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Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 173 - 173
1 Dec 2013
Sonntag R Koch S Merziger J Rieger JS Reinders J Reiner T Kretzer JP
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Background. Migration analysis after total joint arthroplasty are performed using EBRA analysis (Krismer et al., 1997) or - more accurate but also much more cost-intensive and time-consuming – via radiostereometric analysis (RSA). For the latter, additional radiographs from two inclined perspectives are needed in regular intervals in order to define the position of the implant relative to tantalum bone markers which have been implanted during surgery of the artificial joint (Fig. 1). Modern analysis software promises a migration precision along the stem axis of a hip implant of less than 100 μm (Witvoet-Brahm et al., 2007). However, as the analysis is performed semi-automatically, the results are still dependent on the subjective evaluation of the X-rays by the observer. Thus, the present phantom study aims at evaluating the inter- and intra-observer reliability, the repeatability as well as the precision and gives insight into the potential and limits of the RSA method. Materials and Methods. Considering published models, an RSA phantom model has been developed which allows a continuous and exact positioning of the prostheses in all six degrees of freedom (Fig. 2). The position sensitivities of the translative and rotative positioning components are 1 μm and 5 to 24, respectively. The roentgen setup and Model-Based RSA software (3.3, Medis specials bv, Leiden, Netherlands) was evaluated using the SL-PLUS® standard hip stem (size 7, Smith & Nephew, Baar, Switzerland). The inter-observer (10 repetitions) and intra-observer (3 observers) reliability have been considered. Additionally, the influences of the model repositioning and inclination as well as the precision after migration and rotation along the stem axis are investigated. Results and Discussion. Precision along the stem axis was determined to 161 μm (± 230 μm), in the lateral plane 100 μm (± 85 μm) and maximal rotations to 0.524° (± 1.268°). High reproducibility (intra-observer reliability) is reported with relevant influences of the inclination of the implant on the radiograph, in particular for the first clinical scene which serves as a reference. Deviations after translations along the stem axis are 0.37 ± 1.92% and −3.28 ± 6.62% after rotations. In conclusion, the precision given by the software producer of less than 100 μm could not be verified. Beside the limitations from the software, potential sources of errors are the subjective analysis by the observer, a small number of bone markers and the positioning of the implant (patient) during X-ray examination. Though, Model-Based RSA largely outmatches the EBRA approach in terms of measuring implant migration. However, standardization of the X-rays and RSA analysis is recommended


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 89 - 89
1 Sep 2012
Amirault DJ Gross M Hennigar A Laende E Dunbar MJ
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Purpose. The foam metal backed Advance BioFoam Knee Arthroplasty components utilize a porous titanium coating on the underside of the tibial baseplate, intended to promote bone in-growth and provide a more robust bone-implant interface without cement. There is also a version of the Biofoam Advance that incorporates screwed fixation that allows for augmented fixation with up to four titanium screws; however, it is not clear that this augmentation is necessary. The purpose of this study was to employ radiostereometric analysis (RSA) to compare implant migration in a randomized controlled trial of this implant design with or without screw fixation. Method. Fifty-one patients were randomized to receive a BioFoam total knee replacement (Wright Medical Technologies) with or without screw fixaiton. During surgery, eight tantalum markers, one millimetre in diameter, were inserted into the proximal tibia. Using a calibration box, stereo RSA radiographs were taken post-operatively and then again at six weeks and three, six and 12 months following surgery. Model Based RSA was used with 3D models of the tibial component to measure migration. Health status and functional outcome measures were recorded to quantify functional status of subjects before surgery and at each follow-up interval. Results. The migration results at one year, calculated as maximum total point motion (MTPM) were 1.751.93 mm for with screw fixation and 1.431.41 mm without screw fixation (p value =0.575). The clinical precision of the MTPM metric is 0.33 mm, calculated as the standard deviation of measurements made from double exams of all patients. There were no significant differences between groups for all other outcomes. Conclusion. The migration results at one year indicate that the addition of screws does not impact implant fixation in the short term. Longer term monitoring of the migration of these two implant groups will continue. Although higher than the migration seen with cemented tibial components, the amount of migration is comparable to other uncemented designs


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 538 - 538
1 Nov 2011
Lebel B Pineau V Gouzy S Geais L Vielpeau C
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Purpose of the study: Several authors have focused attention on the kinematics of total knee arthroplasty. In vitro studies have shown the influence of prosthetic kinematics on wear of the tibial insert. In vivo, investigations are limited for this important parameter. We propose computer algorithm which gives a linear assessment of femur penetration into the tibial insert. The purpose of this work was to test this measurement by radiostereometric analysis (RSA) on pre-worn prosthesis models. Material and methods: A resin plateau was manufactured with four Triatlhon posterior stabilized inserts. Three of these inserts were pre-worn on the medial glenoid; wear varied from 0.8 to 1.2 mm. The wear pattern was controlled by a computer program in order to localize it on a posteromedial gliding band posteriorly to the posterior stabilization implant. A femoral component was implanted on dry bone and loaded on a simulator. RSA images were obtained for each of the plateau. Five series of images were obtained from 0 to 40° flexion. The measurement method consisted in defined a perfect middle plane based on the analysis of tantalum beads embedded in the resin plateau, the to define the point the closest to this plane belonging to the medial condyle. The norm of the normal vector for this plane passing through the lowest point of the femur was the reference. The difference of the norms of the vectors constructed from the healthy plateau and the worn plateaus was defined as penetration of the femur into the tibia insert. The rood mean square (RMS) method was used to measure intraobserver variability and the interclass coefficient of correlation (ICC) was determined. Results and Discussion: Our results were encouraging. 0.8/to 1.12 mm wear was detected with very good accuracy. The data spread was however wide, irrespective of the wear value. The images in flexion of this model provided the most reliable readings. This study is the first offering an approach to wear measurement in vivo. The data spread should be improved by fine tuning the experimental model and the pre-wear pattern. Conclusion: In vivo measurement of TKA wear remains a challenge in clinical medicine. Our work demonstrate the feasibility of using RSA


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 534 - 534
1 Nov 2011
Pineau V Lebel B Gouzy S Emily S Dutheil J Vielpeau C
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Purpose of the study: The concept introduced by Gilles Bousquet is an effective arm against dislocation of total hip arthroplasty (THA), as has been demonstrated in clinical series with a long follow-up. There remain certain questions concerning wear of dual mobility cups. We propose a radiostereometrical analysis (RSA) of femoral head migration in this type of implant. Our objective was to establish an accurate measurement and determine the intra- and interobserver variabilities. Material and methods: A THA model was implanted and loaded with a simulator. Penetration of the implants was measured using a specially designed polyethylene insert with increasingly concentric wear (from 0, 0.25, 0.5 to 0.75 mm). Three investigators analysed (7 times in a double-blind protocol) the RSA images of these four inserts. The investigators were an expert (I), well-trained (II), naive (III). The accuracy of the measurement as well as the intra- and interobserver variabilities were determined using the root mean square (RMS) method, the interclass coefficient of correlation (ICC), the Bland and Altman analyses, and weighted Kappa analysis. Results: Regarding accuracy, the RMS was 0.0388 [CI95: 0.02266–0.05564]. The mean error for preworn inserts was respectively 0.022mm (for 0.25mm prewear), 0.59mm (for 0.5mm), and 0.022mm (for 0.75mm). The intra-observer ICC was 0.9714 [0.9028–0.9918] for investigator I. The interobserver ICCs between investigators I and II and between I and III were respectively 0.943 and 0.968. The weighted kappa coefficients between I and II and between I and III were 0.827 and 0.849. The Bland and Altman analysis confirmed these results. Discussion: Several RSA protocols could be designed to measure wear of the dual mobility cup. We chose detection of the wear pattern instead of the tantalum beads method. Our protocol, using a simple geometric model and not the manufacturers CAD files, showed an accuracy comparable with manufacturing tolerances with low variability. Conclusion: This study validated our measurement method, a prerequisite for a randomized multicentric study which has been initiated to compare, by RSA, penetration of the head into the double mobility insert versus a fixed insert


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 14 - 14
1 Jan 2016
Grosser D Mercer G Wilson C Nilsson K Krishnan J
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Background. Safety and efficacy of novel prostheses relies on the determination of early implant migration and subsequent risk of loosening. Radiostereometric Analysis (RSA) has been used to evaluate the clinical failure risks of femoral stems by reporting distal migration, a measure of stem subsidence, when examining early migration characteristics. The migratory patterns of femoral stems, 24 months postoperatively, have provided a surrogate outcome measure to determine implant stabilisation and predict long-term performance and survivorship. RSA assessed femoral stem migration and provided comparison of the early migration characteristics with published data of a clinically established counterpart. Methods. Twenty five patients undergoing primary total hip arthroplasty were implanted with a hydroxyapatite-coated femoral stem. The median age was 65 years (range, 43–75 years). During surgery tantalum markers were attached onto the distal tip and shoulder of the stem. Eight tantalum markers were inserted into the femur, four placed in each of the greater and lesser trochanter. RSA examinations were performed postoperatively at 4 to 5 days, 6, 12 and 24 months. Eleven patients who had complete RSA follow-up as well as the valid data from five patients were analysed to determine the movement of the femoral stem relative to the femur and were compared to the published data of a clinically established counterpart. Results. At 24 months the magnitude of migration of the femoral stem translations for the y axis of movement was 0.32 mm (range, 0.00 to 2.04 mm) (Figure 1). The data demonstrates that this migration of the femoral stem occurred primarily in the first 6 months postoperatively and that the migration characteristics exhibit a pattern of implant stabilisation between 6 and 24 months. At 24 months the magnitude of migration of the femoral stem rotations for the longitudinal y axis of movement was 0.60. o. (range, 0.08 to 2.08. o. ). The data demonstrates continuing migration of the femoral stem at 12 months postoperatively with early indications of implant stabilisation between 12 and 24 months. At 24 months the mean subsidence/distal migration of the femoral stem was 0.20 mm (range, −2.04 to 0.32 mm) (Figure 2). At 6 months, two patients (12.5%) exhibited subsidence greater than 0.50 mm with one demonstrating a mean subsidence of 2.00 mm. Between 6 and 24 months these two patients exhibited no more than 0.04 mm of subsidence (Figure 3). The mean retroversion rotation of the stem was 0.10. o. (range, −0.99 to 2.08. o. ). One patient rotated more than 2.00. o. into retroversion at 12 and 24 months postoperatively. Conclusions. In comparison the data demonstrates less stem subsidence and retroversion rotation than published data for a cementless hydroxyapatite-coated femoral stem when observing early migration characteristics. The magnitude and pattern of migration exhibited is indicative of good clinical outcomes and is comparable with a clinically established counterpart after short-term follow-up with RSA. These findings and comparisons highlight the early migration characteristics of a hydroxyapatite-coated femoral stem, however the analysis and comparison of the migratory pattern and characteristics over the mid-term follow-up will confirm implant stabilisation


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 387 - 387
1 Jul 2010
Dahl J Rydinge J Rohrl S Snorrason F Nordsletten L
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Introduction: C-stem is a triple taper polished femoral stem. The rationale for this design is to achieve an evenly distributed proximal loading of the cement mantle. This design is thought to enhance stability of the stem inside the mantle and lead to bone remodelling medially. There is to our knowledge no randomized trial comparing this stem to a well documented stem. We chose to compare it to the best documented stem in the Norwegian arthroplasty register, the Charnley monoblock. Methods: 70 patients scheduled for total hip replacement were randomized to either C-stem or Charnley monoblock. All received a 22 mm stainless steel head, OGGEE cup and Palacos Cement with Gentamycin. We used a transgluteal approach in all cases. Harris and Oxford hip scores were measured preoperatively and after two years. Standard X-rays were taken postoperatively and after two years. Radiostereometry (RSA) was done postoperatively and after 3,6,12 and 24 months. Results: There was no significant difference in Harris or Oxford hip scores after two years. RSA after two years: (table deleted). Discussion: Polished tapered stems are designed to sink inside the mantle. Our results confirm this theory for the C-stem. The subsidence is comparable to other collarless tapered stems with good long-term survival. For all other migrations/rotations the C-stem is as stable as the Charnley monoblock. This predicts good long-term results for this stem


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_V | Pages 4 - 4
1 Mar 2012
Karuppiah S Downing M Broadbent R Christie M Carnegie C Ashcroft G Johnstone A
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Due to its popularity of intramedullary nails (IMN) high success rate, newer design (titanium) IMN system have been introduced to replace stainless steel system. However the stability provided by the titanium IMN

may not be adequate, there by influencing the union rate.

We aimed to compare the results of both IMN systems via prospective clinical study and biomechanical testing using RSA.

Biomechanical study

This study was done in an experimental set-up which consisted of a physically simulated femoral shaft fractures models fixed with a stainless steel (Russell Taylor) or Titanium (Trigen) IM nailing system. Two common fracture configurations with stimulated weight bearing conditions were used and the axis of fragment movements recorded.

Clinical study

The data on two groups of patients were collected as part of a prospective cohort study. Details of the implant, such as size of nail, cross screw lengths, screw thickness, etc. was collected. Patients were followed up for a minimum of 4 months and details of clinical complications recorded


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 136 - 136
1 Jul 2014
Penny J Ding M Ovesen O Varmarken J Overgaard S
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Summary

Despite high revision rates, the mean two year migration of the ASRTM cup is within an acceptable threshold. Slightly higher migration rates found for the M2a- Magnum™ Porous Coated Acetabular Component but longer follow up is needed to establish if this implant is at risk.

Introduction

RSA can detect the migration of an implant, and continuous migration is a predictor for failure (1). The ASRTM resurfacing implant was withdrawn from the marked due to excessive failure rate but showed initial femoral component stability. The aim of this study was to investigate the initial implant stability for the ASR cup as a possible explanation for the high revision rate, and to compare it to another metal on metal (MoM) cup.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 392 - 392
1 Jul 2010
Dahl J Nivbrant B Søderlund P Nordsletten L Röhrl SM
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Introduction: Increased wear is associated with aseptic loosening and late dislocations. Hard on hard bearings may reduce wear but still have topics of concern such as free metal ions in metal on metal bearings and the risk for fracture in ceramic articulations. Ceramic heads against conventional polyethylene is also used with the intention to reduce wear. But this effect has not been conclusively documented in the literature and is still discussed. 87 patients were operated consecutively by the same surgeon with the same surgical technique. All patients received a cemented all poly cup sterilized with irradiation in inert atmosphere and a cemented stem. Head size was 28 mm in all patients. 40 patients received cobalt-chrome heads and 47 patients aluminiumoxid heads. The patients were followed with RSA for 10 years and analysed for wear.

Results: Mean (SEM) wear for the group with cobalt chrome heads was 0.93 mm (0.13) and for the group with aluminiumoxide was 0.43 mm (0.08) (p = 0.001).

Discussion: We found significantly less wear with aluminumoxide heads compared to cobalt-chrome heads. The wear results in the cobalt-chrome group correlate well to wear values in the literature for conventional polyethylene. Although the polyethylene in this study is partly cross-linked (3Mrad) it is not clear whether these results can be extrapolated directly to the use of highly cross-linked PE. If longer follow-ups confirm the mechanical stability of highly cross-linked PE, ceramic heads might contribute additionally to the reduction of wear.

In conclusion we found significantly reduced wear for aluminumoxide heads compared to cobalt chrome heads which could be beneficial for young and active patients.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 83 - 83
1 Jan 2016
Nebergall A Malchau H Greene M
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Introduction

RSA is widely accepted as a precise method to asses wear and migration early in the postoperative period. In traditional RSA, one segment defines both the acetabular shell and the polyethylene liner. However, inserting beads into the liner permits employment of the shell and liner as two separate segments, thus enabling distinct analysis of the precision of three measurement methods in determining wear and acetabular shell migration. The purpose of this in vivo follow-up study was to determine if assigning the shell and liner as one combined, or two individual segments affected the precision of RSA measurements of wear and shell stability.

Methods

The UmRSA program was used to analyze the double examinations of 51 hips to determine if there was a difference in precision among 3 measurement methods: the shell only, the liner only, and the shell + liner combined segment. Tantalum beads were inserted into the liner and pelvic bone surrounding the shell intraoperatively for the purpose of RSA. Polyethylene wear was measured using point motion of the center of the head with respect to 3 different segments: 1) liner only, 2) the shell only and, 3) shell + liner segment. Cup stability was measured by segment motion comparing the stable pelvic segment to 1) the liner segment, 2) the shell only segment, and 3) the shell + liner segment. The Wilcoxon paired signed-ranks test was used to determine differences in condition number and bead counts among the 3 measurement methods (p ≤0.05).


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLI | Pages 64 - 64
1 Sep 2012
Humad A Freeman B Moore R Callary S Halldin K
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Anterior lumbar inter-body fusion (ALIF) is a surgical procedure that is available to chronic lower back pain patients who fail to respond to conservative treatments. Failure to achieve fusion may result in persistence of pain. Fusion of the lumber vertebral segment is more accurately assessed using fine-cut helical Computed tomography (CT) scans (0.25 mm thickness slices). Unfortunately this technique exposes the body to high radiation dose with hazard of increase risk of late malignancy. An alternative imaging tool is radiostereometry (RSA) which developed as a means to determine the magnitude of relative motion between two rigid bodies. In this study we used RSA to detect movement at the fused lumbar segment (ALIF site) during flexion and extension and compare the results obtained with fine-cut helical CT scan using histopathology as final gold standard assessment tool. ALIF of three levels of lumbar spine (L1-L2, L3-L4, and L5-L6) was done in 9 sheep. The sheep divided into three groups (3sheep each). The first group had RSA assessment immediately, 3, and 6 months after surgery. The second group had RSA immediately, 3, 6, 9 months after surgery. The third group had an RSA immediately, 3, 6, 9, 12 months after surgery All the animals were humanly killed immediately after having the last scheduled RSA (group1, group2, and group 3 sheep were killed 6 month, 9month and 12 months after surgery respectively). This followed by in vitro fine cut CT and histopathology after the animals are scarified. Micro CT scan has been also used to identify the area where histopathology slide should be made to pick up fusion. Fine cut CT scan assessment for all sheep were done. The CT scan has been reported by two independent radiologists. Histopathology has been started and will finish in 2 weeks. RSA showed there was significant increasing stiffness of the spine though the fused segments as the time pass on compare to immediate postoperative assessment. CT scan were done and showed variable fusion though out the spinal segments. Histopathology of all sheep has been started and the results will be available in 2 weeks which will be followed by statistical assessment to decide how accurate RSA compare to CT scan in assessment of fusion


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 912 - 919
1 Aug 2023
Cunningham LJ Walton M Bale S Trail IA

Aims. Reverse total shoulder arthroplasty (rTSA) can be used in complex cases when the glenoid requires reconstruction. In this study, a baseplate with composite bone autograft and a central trabecular titanium peg was implanted, and its migration was assessed for two years postoperatively using radiostereometric analysis (RSA). Methods. A total of 14 patients who underwent a rTSA with an autograft consented to participate. Of these, 11 had a primary rTSA using humeral head autograft and three had a revision rTSA with autograft harvested from the iliac crest. The mean age of the patients was 66 years (39 to 81). Tantalum beads were implanted in the scapula around the glenoid. RSA imaging (stereographic radiographs) was undertaken immediately postoperatively and at three, six, 12, and 24 months. Analysis was completed using model-based RSA software. Outcomes were collected preoperatively and at two years postoperatively, including the Oxford Shoulder Score, the American Shoulder and Elbow Score, and a visual analogue score for pain. A Constant score was also obtained for the assessment of strength and range of motion. Results. RSA analysis showed a small increase in all translation and rotational values up to six months postoperatively, consistent with settling of the implant. The mean values plateaued by 12 months, with no evidence of further migration. In four patients, there was significant variation outside the mean, which corresponded to postoperative complications. There was a significant improvement in the clinical and patient-reported outcomes from the preoperative values to those at two years postoperatively (p < 0.001). Conclusion. These findings show, using RSA, that a glenoid baseplate composite of a trabecular titanium peg with autograft stabilizes within the glenoid about 12 months after surgery, and reinforce findings from a previous study of this implant/graft with CT scans at two years postoperatively, indicating that this type of structural composite results in sound early fixation. Cite this article: Bone Joint J 2023;105-B(8):912–919


Bone & Joint Open
Vol. 4, Issue 11 | Pages 839 - 845
6 Nov 2023
Callary SA Sharma DK D’Apollonio TM Campbell DG

Aims. Radiostereometric analysis (RSA) is the most accurate radiological method to measure in vivo wear of highly cross-linked polyethylene (XLPE) acetabular components. We have previously reported very low wear rates for a sequentially irradiated and annealed X3 XLPE liner (Stryker Orthopaedics, USA) when used in conjunction with a 32 mm femoral heads at ten-year follow-up. Only two studies have reported the long-term wear rate of X3 liners used in conjunction with larger heads using plain radiographs which have poor sensitivity. The aim of this study was to measure the ten-year wear of thin X3 XLPE liners against larger 36 or 40 mm articulations with RSA. Methods. We prospectively reviewed 19 patients who underwent primary cementless THA with the XLPE acetabular liner (X3) and a 36 or 40 mm femoral head with a resultant liner thickness of at least 5.8 mm. RSA radiographs at one week, six months, and one, two, five, and ten years postoperatively and femoral head penetration within the acetabular component were measured with UmRSA software. Of the initial 19 patients, 12 were available at the ten-year time point. Results. The median proximal, 2D, and 3D wear rates calculated between one and ten years were all less than 0.005 mm/year, with no patient recording a proximal wear rate of more than 0.021 mm/year. Importantly, there was no increase in the wear rate between five and ten years. Conclusion. The very low wear rate of X3 XLPE liners with larger articulations remains encouraging for the future clinical performance of this material. Cite this article: Bone Jt Open 2023;4(11):839–845


Bone & Joint Open
Vol. 4, Issue 5 | Pages 385 - 392
24 May 2023
Turgeon TR Hedden DR Bohm ER Burnell CD

Aims. Instability is a common cause of failure after total hip arthroplasty. A novel reverse total hip has been developed, with a femoral cup and acetabular ball, creating enhanced mechanical stability. The purpose of this study was to assess the implant fixation using radiostereometric analysis (RSA), and the clinical safety and efficacy of this novel design. Methods. Patients with end-stage osteoarthritis were enrolled in a prospective cohort at a single centre. The cohort consisted of 11 females and 11 males with mean age of 70.6 years (SD 3.5) and BMI of 31.0 kg/m. 2. (SD 5.7). Implant fixation was evaluated using RSA as well as Western Ontario and McMaster Universities Osteoarthritis Index, Harris Hip Score, Oxford Hip Score, Hip disability and Osteoarthritis Outcome Score, 38-item Short Form survey, and EuroQol five-dimension health questionnaire scores at two-year follow-up. At least one acetabular screw was used in all cases. RSA markers were inserted into the innominate bone and proximal femur with imaging at six weeks (baseline) and six, 12, and 24 months. Independent-samples t-tests were used to compare to published thresholds. Results. Mean acetabular subsidence from baseline to 24 months was 0.087 mm (SD 0.152), below the critical threshold of 0.2 mm (p = 0.005). Mean femoral subsidence from baseline to 24 months was -0.002 mm (SD 0.194), below the published reference of 0.5 mm (p < 0.001). There was significant improvement in patient-reported outcome measures at 24 months with good to excellent results. Conclusion. RSA analysis demonstrates excellent fixation with a predicted low risk of revision at ten years of this novel reverse total hip system. Clinical outcomes were consistent with safe and effective hip replacement prostheses. Cite this article: Bone Jt Open 2023;4(5):385–392


Bone & Joint Open
Vol. 5, Issue 1 | Pages 37 - 45
19 Jan 2024
Alm CE Karlsten A Madsen JE Nordsletten L Brattgjerd JE Pripp AH Frihagen F Röhrl SM

Aims. Despite limited clinical scientific backing, an additional trochanteric stabilizing plate (TSP) has been advocated when treating unstable trochanteric fractures with a sliding hip screw (SHS). We aimed to explore whether the TSP would result in less post operative fracture motion, compared to SHS alone. Methods. Overall, 31 patients with AO/OTA 31-A2 trochanteric fractures were randomized to either a SHS alone or a SHS with an additional TSP. To compare postoperative fracture motion, radiostereometric analysis (RSA) was performed before and after weightbearing, and then at four, eight, 12, 26, and 52 weeks. With the “after weightbearing” images as baseline, we calculated translations and rotations, including shortening and medialization of the femoral shaft. Results. Similar migration profiles were observed in all directions during the course of healing. At one year, eight patients in the SHS group and 12 patients in the TSP group were available for analysis, finding a clinically non-relevant, and statistically non-significant, difference in total translation of 1 mm (95% confidence interval -4.7 to 2.9) in favour of the TSP group. In line with the migration data, no significant differences in clinical outcomes were found. Conclusion. The TSP did not influence the course of healing or postoperative fracture motion compared to SHS alone. Based on our results, routine use of the TSP in AO/OTA 31-A2 trochanteric fractures cannot be recommended. The TSP has been shown, in biomechanical studies, to increase stability in sliding hip screw constructs in both unstable and intermediate stable trochanteric fractures, but the clinical evidence is limited. This study showed no advantage of the TSP in unstable (AO 31-A2) fractures in elderly patients when fracture movement was evaluated with radiostereometric analysis. Cite this article: Bone Jt Open 2024;5(1):37–45


The Bone & Joint Journal
Vol. 104-B, Issue 7 | Pages 875 - 883
1 Jul 2022
Mills K Wymenga AB van Hellemondt GG Heesterbeek PJC

Aims. Both the femoral and tibial component are usually cemented at revision total knee arthroplasty (rTKA), while stems can be added with either cemented or press-fit (hybrid) fixation. The aim of this study was to compare the long-term stability of rTKA with cemented and press-fitted stems, using radiostereometric analysis (RSA). Methods. This is a follow-up of a randomized controlled trial, initially involving 32 patients, of whom 19 (nine cemented, ten hybrid) were available for follow-up ten years postoperatively, when further RSA measurements were made. Micromotion of the femoral and tibial components was assessed using model-based RSA software (RSAcore). The clinical outcome was evaluated using the Knee Society Score (KSS), the Knee injury and Osteoarthritis Outcome Score (KOOS), and visual analogue scale (pain and satisfaction). Results. The median total femoral translation and rotation at ten years were 0.39 mm (interquartile range (IQR) 0.20 to 0.54) and 0.59° (IQR 0.46° to 0.73°) for the cemented group and 0.70 mm (IQR 0.15 to 0.77) and 0.78° (IQR 0.47° to 1.43°) for the hybrid group. For the tibial components this was 0.38 mm (IQR 0.33 to 0.85) and 0.98° (IQR 0.38° to 1.34°) for the cemented group and 0.42 mm (IQR 0.30 to 0.52) and 0.72° (IQR 0.62° to 0.82°) for the hybrid group. None of these values were significantly different between the two groups and there were no significant differences between the clinical scores in the two groups at this time. There was only one re-revision, in the hybrid group, for infection and not for aseptic loosening. Conclusion. These results show good long-term fixation with no difference in micromotion and clinical outcome between fully cemented and hybrid fixation in rTKA, which builds on earlier short- to mid-term results. The patients all had type I or II osseous defects, which may in part explain the good results. Cite this article: Bone Joint J 2022;104-B(7):875–883


The Bone & Joint Journal
Vol. 105-B, Issue 2 | Pages 148 - 157
1 Feb 2023
Koster LA Rassir R Kaptein BL Sierevelt IN Schager M Nelissen RGHH Nolte PA

Aims. The primary aim of this study was to compare the migration of the femoral and tibial components of the cementless rotating platform Attune and Low Contact Stress (LCS) total knee arthroplasty (TKA) designs, two years postoperatively, using radiostereometric analysis (RSA) in order to assess the risk of the development of aseptic loosening. A secondary aim was to compare clinical and patient-reported outcome measures (PROMs) between the designs. Methods. A total of 61 TKAs were analyzed in this randomized clinical RSA trial. RSA examinations were performed one day and three, six, 12, and 24 months postoperatively. The maximal total point motion (MPTM), translations, and rotations of the components were analyzed. PROMs and clinical data were collected preoperatively and at six weeks and three, six, 12, and 24 months postoperatively. Linear mixed effect modelling was used for statistical analyses. Results. The mean MTPM two years postoperatively (95% confidence interval (CI)) of the Attune femoral component (0.92 mm (0.75 to 1.11)) differed significantly from that of the LCS TKA (1.72 mm (1.47 to 2.00), p < 0.001). The Attune femoral component subsided, tilted (anteroposteriorly), and rotated (internal-external) significantly less. The mean tibial MTPM two years postoperatively did not differ significantly, being 1.11 mm (0.94 to 1.30) and 1.17 mm (0.99 to 1.36, p = 0.447) for the Attune and LCS components, respectively. The rate of migration in the second postoperative year was negligible for the femoral and tibial components of both designs. The mean pain-at-rest (numerical rating scale (NRS)-rest) in the Attune group was significantly less compared with that in the LCS group during the entire follow-up period. At three months postoperatively, the Knee injury and Osteoarthritis Outcome Physical Function Shortform score, the Oxford Knee Score, and the NRS-activity scores were significantly better in the Attune group. Conclusion. The mean MTPM of the femoral components of the cementless rotating platform Attune was significantly less compared with that of the LCS design. This was reflected mainly in significantly less subsidence, posterior tilting, and internal rotation. The mean tibial MTPMs were not significantly different. During the second postoperative year, the components of both designs stabilized and low risks for the development of aseptic loosening are expected. Cite this article: Bone Joint J 2023;105-B(2):148–157


The Bone & Joint Journal
Vol. 104-B, Issue 4 | Pages 444 - 451
1 Apr 2022
Laende EK Mills Flemming J Astephen Wilson JL Cantoni E Dunbar MJ

Aims. Thresholds of acceptable early migration of the components in total knee arthroplasty (TKA) have traditionally ignored the effects of patient and implant factors that may influence migration. The aim of this study was to determine which of these factors are associated with overall longitudinal migration of well-fixed tibial components following TKA. Methods. Radiostereometric analysis (RSA) data over a two-year period were available for 419 successful primary TKAs (267 cemented and 152 uncemented in 257 female and 162 male patients). Longitudinal analysis of data using marginal models was performed to examine the associations of patient factors (age, sex, BMI, smoking status) and implant factors (cemented or uncemented, the size of the implant) with maximum total point motion (MTPM) migration. Analyses were also performed on subgroups based on sex and fixation. Results. In the overall group, only fixation was significantly associated with migration (p < 0.001). For uncemented tibial components in males, smoking was significantly associated with lower migration (p = 0.030) and BMI approached significance (p = 0.061). For females with uncemented components, smoking (p = 0.081) and age (p = 0.063) approached significance and were both associated with increased migration. The small number of self-reported smokers in this study warrants cautious interpretation and further investigation. For cemented components in females, larger sizes of tibial component were significantly associated with increased migration (p = 0.004). No factors were significant for cemented components in males. Conclusion. The migration of uncemented tibial components was more sensitive to patient factors than cemented implants. These differences were not consistent by sex, suggesting that it may be of value to evaluate female and male patients separately following TKA. Cite this article: Bone Joint J 2022;104-B(4):444–451


Aims. The aim of this study was to compare the mid-term patient-reported outcome, bone remodelling, and migration of a short stem (Collum Femoris Preserving; CFP) with a conventional uncemented stem (Corail). Methods. Of 81 patients who were initially enrolled, 71 were available at five years’ follow-up. The outcomes at two years have previously been reported. The primary outcome measure was the clinical result assessed using the Oxford Hip Score (OHS). Secondary outcomes were the migration of the stem, measured using radiostereometric analysis (RSA), change of bone mineral density (BMD) around the stem, the development of radiolucent lines, and additional patient-reported outcome measures (PROMs). Results. There were no statistically significant differences between the groups regarding PROMs (median OHS (CFP 45 (interquartile range (IQR) 35 to 48); Corail 45 (IQR 40 to 48); p = 0.568). RSA showed stable stems in both groups, with little or no further subsidence between two and five years. Resorption of the femoral neck was evident in nine patients in the CFP group and in none of the 15 Corail stems with a collar that could be studied. Dual X-ray absorbiometry showed a significantly higher loss of BMD in the proximal Gruen zones in the CFP group (mean changes in BMD: Gruen zone 1, CFP -9.5 (95% confidence interval (CI) -14.8 to -4.2), Corail 1.0 (95% CI 3.4 to 5.4); Gruen zone 7, CFP -23.0 (95% CI -29.4 to -16.6), Corail -7.2 (95% CI -15.9 to 1.4). Two CFP stems were revised before two years’ follow-up due to loosening, and one Corail stem was revised after two years due to chronic infection. Conclusion. The CFP stem has a similar clinical outcome and subsidence pattern when compared with the Corail stem. More pronounced proximal stress-shielding was seen with the CFP stem, suggesting diaphyseal fixation, and questioning its femoral neck-sparing properties in the long term. Cite this article: Bone Joint J 2022;104-B(5):581–588


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 19 - 26
1 Jan 2022
Sevaldsen K Schnell Husby O Lian ØB Farran KM Schnell Husby V

Aims. Highly polished stems with force-closed design have shown satisfactory clinical results despite being related to relatively high early migration. It has been suggested that the minimal thickness of cement mantles surrounding the femoral stem should be 2 mm to 4 mm to avoid aseptic loosening. The line-to-line cementing technique of the femoral stem, designed to achieve stem press-fit, challenges this opinion. We compared the migration of a highly polished stem with force-closed design by standard and line-to-line cementing to investigate whether differences in early migration of the stems occur in a clinical study. Methods. In this single-blind, randomized controlled, clinical radiostereometric analysis (RSA) study, the migration pattern of the cemented Corail hip stem was compared between line-to-line and standard cementing in 48 arthroplasties. The primary outcome measure was femoral stem migration in terms of rotation and translation around and along with the X-, Y-, and Z- axes measured using model-based RSA at three, 12, and 24 months. A linear mixed-effects model was used for statistical analysis. Results. Results from mixed model analyses revealed a lower mean retroversion for line-to-line (0.72° (95% confidence interval (CI) 0.38° to 1.07°; p < 0.001), but no significant differences in subsidence between the techniques (-0.15 mm (95% CI -0.53 to 0.227; p = 0.429) at 24 months. Radiolucent lines measuring < 2 mm wide were found in three and five arthroplasties cemented by the standard and line-to-line method, respectively. Conclusion. The cemented Corail stem with a force-closed design seems to settle earlier and better with the line-to-line cementing method, although for subsidence the difference was not significant. However, the lower rate of migration into retroversion may reduce the wear and cement deformation, contributing to good long-term fixation and implant survival. Cite this article: Bone Joint J 2022;104-B(1):19–26


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 76 - 82
1 Jan 2022
ten Brinke B Hesseling B Eygendaal D Hoelen MA Mathijssen NMC

Aims. Stemless humeral implants have been developed to overcome stem-related complications in total shoulder arthroplasty (TSA). However, stemless implant designs may hypothetically result in less stable initial fixation, potentially affecting long-term survival. The aim of this study is to investigate early fixation and migration patterns of the stemless humeral component of the Simpliciti Shoulder System and to evaluate clinical outcomes. Methods. In this prospective cohort study, radiostereometric analysis (RSA) radiographs were obtained in 24 patients at one day, six weeks, six months, one year, and two years postoperatively. Migration was calculated using model-based RSA. Clinical outcomes were evaluated using the visual analogue scale (VAS), the Oxford Shoulder Score (OSS), the Constant-Murley Score (CMS), and the Disabilities of the Arm, Shoulder and Hand (DASH) score. Results. At two years, median translation along the x-, y-, and z-axis was -0.12 mm (interquartile range (IQR) -0.18 to 0.02), -0.17 mm (IQR -0.27 to -0.09), and 0.09 mm (IQR 0.02 to 0.31). Median rotation around the x-, y-, and z-axis was 0.12° (IQR -0.50 to 0.57), -0.98° (IQR -1.83 to 1.23), and 0.09° (IQR -0.76 to 0.30). Overall, 20 prostheses stabilized within 12 months postoperatively. Four prostheses showed continuous migration between 12 and 24 months. At two-year follow-up, with the exception of one revised prosthesis, all clinical scores improved significantly (median VAS difference at rest: -3.0 (IQR -1.5 to -6.0); OSS 22.0 (IQR 15.0 to 25.0); CMS 29.5 (IQR 15.0 to 35.75); and DASH -30.0 (IQR -20.6 to -41.67) (all p < 0.001)) with the exception of one revised prosthesis. Conclusion. In conclusion, we found that 20 out of 24 implants stabilized within 12 months postoperatively. The significance of continuous migration in four implants is unclear and future research on the predictive value of early migration for future loosening in TSA is required. Clinical results revealed a clinically relevant improvement. Cite this article: Bone Joint J 2022;104-B(1):76–82


Bone & Joint Open
Vol. 2, Issue 9 | Pages 737 - 744
1 Sep 2021
Øhrn F Lian ØB Tsukanaka M Röhrl SM

Aims. Medial pivot (MP) total knee arthroplasties (TKAs) were designed to mimic native knee kinematics with their deep medial congruent fitting of the tibia to the femur almost like a ball-on-socket, and a flat lateral part. GMK Sphere is a novel MP implant. Our primary aim was to study the migration pattern of the tibial tray of this TKA. Methods. A total of 31 patients were recruited to this single-group radiostereometric analysis (RSA) study and received a medial pivot GMK Sphere TKA. The distributions of male patients versus female patients and right versus left knees were 21:10 and 17:14, respectively. Mean BMI was 29 kg/m. 2. (95% confidence interval (CI) 27 to 30) and mean age at surgery was 63 years (95% CI 61 to 66). Maximum total point motions (MTPMs), medial, proximal, and anterior translations and transversal, internal, and varus rotations were calculated at three, 12, and 24 months. Patient-reported outcome measure data were also retrieved. Results. MTPMs at three, 12, and 24 months were 1.0 mm (95% CI 0.8 to 1.2), 1.3 mm (95% CI 0.9 to 1.7), and 1.4 mm (0.8 to 2.0), respectively. The Forgotten Joint Score was 79 (95% CI 39 to 95) and Knee Injury and Osteoarthritis Outcome Score obtained at two years was 94 (95% CI 81 to 100), 86 (95% CI 75 to 93), 94 (95% CI 88 to 100), 69 (95% CI 48 to 88), and 81 (95% CI59 to 100) for Pain, Symptoms, Activities of Daily Living, Sport & Recreation, and Quality of Life, respectively. Conclusion. In conclusion, we found that the mean increase in MTPM was lower than 0.2 mm between 12 and 24 months and thus apparently stable. Yet the GMK Sphere had higher migration at one and two years than anticipated. Based on current RSA data, we therefore cannot conclude on the long-term performance of the implant, pending further assessment. Cite this article: Bone Jt Open 2021;2(9):737–744


Bone & Joint Open
Vol. 5, Issue 1 | Pages 20 - 27
17 Jan 2024
Turgeon TR Vasarhelyi E Howard J Teeter M Righolt CH Gascoyne T Bohm E

Aims

A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis.

Methods

Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits.


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 435 - 441
1 May 2024
Angelomenos V Mohaddes M Kärrholm J Malchau H Shareghi B Itayem R

Aims

Refobacin Bone Cement R and Palacos R + G bone cement were introduced to replace the original cement Refobacin Palacos R in 2005. Both cements were assumed to behave in a biomechanically similar fashion to the original cement. The primary aim of this study was to compare the migration of a polished triple-tapered femoral stem fixed with either Refobacin Bone Cement R or Palacos R + G bone cement. Repeated radiostereometric analysis was used to measure migration of the femoral head centre. The secondary aims were evaluation of cement mantle, stem positioning, and patient-reported outcome measures.

Methods

Overall, 75 patients were included in the study and 71 were available at two years postoperatively. Prior to surgery, they were randomized to one of the three combinations studied: Palacos cement with use of the Optivac mixing system, Refobacin with use of the Optivac system, and Refobacin with use of the Optipac system. Cemented MS30 stems and cemented Exceed acetabular components were used in all hips. Postoperative radiographs were used to assess the quality of the cement mantle according to Barrack et al, and the position and migration of the femoral stem. Harris Hip Score, Oxford Hip Score, Forgotten Joint Score, and University of California, Los Angeles Activity Scale were collected.


Bone & Joint Open
Vol. 4, Issue 5 | Pages 306 - 314
3 May 2023
Rilby K Mohaddes M Kärrholm J

Aims

Although the Fitmore Hip Stem has been on the market for almost 15 years, it is still not well documented in randomized controlled trials. This study compares the Fitmore stem with the CementLeSs (CLS) in several different clinical and radiological aspects. The hypothesis is that there will be no difference in outcome between stems.

Methods

In total, 44 patients with bilateral hip osteoarthritis were recruited from the outpatient clinic at a single tertiary orthopaedic centre. The patients were operated with bilateral one-stage total hip arthroplasty. The most painful hip was randomized to either Fitmore or CLS femoral component; the second hip was operated with the femoral component not used on the first side. Patients were evaluated at three and six months and at one, two, and five years postoperatively with patient-reported outcome measures, radiostereometric analysis, dual-energy X-ray absorptiometry, and conventional radiography. A total of 39 patients attended the follow-up visit at two years (primary outcome) and 35 patients at five years. The primary outcome was which hip the patient considered to have the best function at two years.


Bone & Joint 360
Vol. 11, Issue 2 | Pages 15 - 18
1 Apr 2022


Bone & Joint Open
Vol. 2, Issue 12 | Pages 1035 - 1042
1 Dec 2021
Okowinski M Hjorth MH Mosegaard SB Jürgens-Lahnstein JH Storgaard Jakobsen S Hedevang Christensen P Kold S Stilling M

Aims

Femoral bone preparation using compaction technique has been shown to preserve bone and improve implant fixation in animal models. No long-term clinical outcomes are available. There are no significant long-term differences between compaction and broaching techniques for primary total hip arthroplasty (THA) in terms of migration, clinical, and radiological outcomes.

Methods

A total of 28 patients received one-stage bilateral primary THA with cementless femoral stems (56 hips). They were randomized to compaction on one femur and broaching on the contralateral femur. Overall, 13 patients were lost to the ten-year follow-up leaving 30 hips to be evaluated in terms of stem migration (using radiostereometry), radiological changes, Harris Hip Score, Oxford Hip Score, and complications.


Aims. The aim of this study was to compare the migration of the femoral component, five years postoperatively, between patients with a highly cross-linked polyethylene (HXLPE) insert and those with a conventional polyethylene (PE) insert in an uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary aims included clinical outcomes and patient-reported outcome measures (PROMs). We have previously reported the migration and outcome of the tibial components in these patients. Methods. A double-blinded randomized controlled trial was conducted including 96 TKAs. The migration of the femoral component was measured with radiostereometry (RSA) at three and six months and one, two, and five years postoperatively. PROMs were collected preoperatively and at all periods of follow-up. Results. There was no clinically relevant difference in terms of migration of the femoral component or PROMs between the HXLPE and PE groups. The mean difference in migration (maximum total point motion), five years postopeatively, was 0.04 mm (95% CI -0.06 to 0.16) in favour of the PE group. Conclusion. There was no clinically relevant difference in migration of the femoral component, for up to five years between the two groups. These findings will help to establish a benchmark for future studies on migration of femoral components in TKA. Cite this article: Bone Joint J 2024;106-B(8):826–833


Bone & Joint Research
Vol. 13, Issue 5 | Pages 226 - 236
9 May 2024
Jürgens-Lahnstein JH Petersen ET Rytter S Madsen F Søballe K Stilling M

Aims. Micromotion of the polyethylene (PE) inlay may contribute to backside PE wear in addition to articulate wear of total knee arthroplasty (TKA). Using radiostereometric analysis (RSA) with tantalum beads in the PE inlay, we evaluated PE micromotion and its relationship to PE wear. Methods. A total of 23 patients with a mean age of 83 years (77 to 91), were available from a RSA study on cemented TKA with Maxim tibial components (Zimmer Biomet). PE inlay migration, PE wear, tibial component migration, and the anatomical knee axis were evaluated on weightbearing stereoradiographs. PE inlay wear was measured as the deepest penetration of the femoral component into the PE inlay. Results. At mean six years’ follow-up, the PE wear rate was 0.08 mm/year (95% confidence interval 0.06 to 0.09 mm/year). PE inlay external rotation was below the precision limit and did not influence PE wear. Varus knee alignment did not influence PE wear (p = 0.874), but increased tibial component total translation (p = 0.041). Conclusion. The PE inlay was well fixed and there was no relationship between PE stability and PE wear. The PE wear rate was low and similar in the medial and lateral compartments. Varus knee alignment did not influence PE wear. Cite this article: Bone Joint Res 2024;13(5):226–236


Aims. The primary objective of this study was to compare the five-year tibial component migration and wear between highly crosslinked polyethylene (HXLPE) inserts and conventional polyethylene (PE) inserts of the uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary objectives included clinical outcomes and patient-reported outcome measures (PROMs). Methods. A double-blinded, randomized study was conducted including 96 TKAs. Tibial component migration and insert wear were measured with radiostereometric analysis (RSA) at three, six, 12, 24, and 60 months postoperatively. PROMS were collected preoperatively and at all follow-up timepoints. Results. There was no clinically relevant difference in terms of tibial component migration, insert wear, and PROMs between the HXLPE and PE groups. The mean difference in tibial component migration (maximal total point migration (MTPM)) was 0.02 mm (95% confidence interval (CI) -0.07 to 0.11), which is below the value of 0.2 mm considered to be clinically relevant. Wear after five years for HXLPE was 0.16 mm (95% CI 0.05 to 0.27), and for PE was 0.23 mm (95% CI 0.12 to 0.35). The mean difference in wear rate was 0.01 mm/year (95% CI -0.02 to 0.05) in favour of the HXLPE group. Wear is mainly present on the medial side of the insert. Conclusion. There is no clinically relevant difference in tibial component migration and insert wear for up to five years between the HXLPE conventional PE inserts. For the implant studied, the potential advantages of a HXLPE insert remain to be proven under clinical conditions at longer-term follow-up. Cite this article: Bone Joint J 2023;105-B(5):518–525


The Bone & Joint Journal
Vol. 105-B, Issue 1 | Pages 35 - 46
1 Jan 2023
Mills K Wymenga AB Bénard MR Kaptein BL Defoort KC van Hellemondt GG Heesterbeek PJC

Aims. The aim of this study was to compare a bicruciate-retaining (BCR) total knee arthroplasty (TKA) with a posterior cruciate-retaining (CR) TKA design in terms of kinematics, measured using fluoroscopy and stability as micromotion using radiostereometric analysis (RSA). Methods. A total of 40 patients with end-stage osteoarthritis were included in this randomized controlled trial. All patients performed a step-up and lunge task in front of a monoplane fluoroscope one year postoperatively. Femorotibial contact point (CP) locations were determined at every flexion angle and compared between the groups. RSA images were taken at baseline, six weeks, three, six, 12, and 24 months postoperatively. Clinical and functional outcomes were compared postoperatively for two years. Results. The BCR-TKA demonstrated a kinematic pattern comparable to the natural knee’s screw-home mechanism in the step-up task. In the lunge task, the medial CP of the BCR-TKA was more anterior in the early flexion phase, while laterally the CP was more posterior during the entire movement cycle. The BCR-TKA group showed higher tibial migration. No differences were found for the clinical and functional outcomes. Conclusion. The BCR-TKA shows a different kinematic pattern in early flexion/late extension compared to the CR-TKA. The difference between both implants is mostly visible in the flexion phase in which the anterior cruciate ligament is effective; however, both designs fail to fully replicate the motion of a natural knee. The higher migration of the BCR-TKA was concerning and highlights the importance of longer follow-up. Cite this article: Bone Joint J 2023;105-B(1):35–46


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 136 - 143
1 Feb 2024
van der Lelij TJN Marang-van de Mheen PJ Kaptein BL Koster LA Ljung P Nelissen RGHH Toksvig-Larsen S

Aims. The objective of this study was to compare the two-year migration and clinical outcomes of a new cementless hydroxyapatite (HA)-coated titanium acetabular shell with its previous version, which shared the same geometrical design but a different manufacturing process for applying the titanium surface. Methods. Overall, 87 patients undergoing total hip arthroplasty (THA) were randomized to either a Trident II HA or Trident HA shell, each cementless with clusterholes and HA-coating. All components were used in combination with a cemented Exeter V40 femoral stem. Implant migration was measured using radiostereometric analysis (RSA), with radiographs taken within two days of surgery (baseline), and at three, 12, and 24 months postoperatively. Proximal acetabular component migration was the primary outcome measure. Clinical scores and patient-reported outcome measures (PROMs) were collected at each follow-up. Results. Mean proximal migrations at three, 12, and 24 months were 0.08 mm (95% confidence interval (CI) 0.03 to 0.14), 0.11 mm (95% CI 0.06 to 0.16), and 0.14 mm (95% CI 0.09 to 0.20), respectively, in the Trident II HA group, versus 0.11 mm (95% CI 0.06 to 0.16), 0.12 mm (95% CI 0.07 to 0.17), and 0.14 mm (95% CI 0.09 to 0.19) in the Trident HA group (p = 0.875). No significant differences in translations or rotations between the two designs were found in any other direction. Clinical scores and PROMs were comparable between groups, except for an initially greater postoperative improvement in Hip disability and Osteoarthritis Outcome Symptoms score in the Trident HA group (p = 0.033). Conclusion. The Trident II clusterhole HA shell has comparable migration with its predecessor, the Trident hemispherical HA cluster shell, suggesting a similar risk of long-term aseptic loosening. Cite this article: Bone Joint J 2024;106-B(2):136–143


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1206 - 1214
1 Jul 2021
Tsikandylakis G Mortensen KRL Gromov K Mohaddes M Malchau H Troelsen A

Aims. We aimed to investigate if the use of the largest possible cobalt-chromium head articulating with polyethylene acetabular inserts would increase the in vivo wear rate in total hip arthroplasty. Methods. In a single-blinded randomized controlled trial, 96 patients (43 females), at a median age of 63 years (interquartile range (IQR) 57 to 69), were allocated to receive either the largest possible modular femoral head (36 mm to 44 mm) in the thinnest possible insert or a standard 32 mm head. All patients received a vitamin E-doped cross-linked polyethylene insert and a cobalt-chromium head. The primary outcome was proximal head penetration measured with radiostereometric analysis (RSA) at two years. Secondary outcomes were volumetric wear, periacetabular radiolucencies, and patient-reported outcomes. Results. At two years, 44 patients in each group were available for RSA assessment. The median total two-year proximal head penetration was -0.02 mm (IQR -0.09 to 0.07; p = 0.548) for the largest possible head and -0.01 mm (IQR -0.07 to 0.10; p = 0.525) for 32 mm heads. Their difference was not statistically significant (p = 0.323). Neither group demonstrated a bedding-in period. The median steady-state volumetric wear rates were 6.1 mm. 3. /year (IQR -59 to 57) and 3.5 mm. 3. /year (-21 to 34) respectively, and did not differ between the groups (p = 0.848). There were no statistically significant differences in periacetabular radiolucencies or patient-reported outcomes. Conclusion. The use of the largest possible metal head did not increase vitamin E-doped cross-linked polyethylene wear compared with 32 mm heads at two years. Linear wear was negligible and volumetric wear rates were very low in both head size groups. There was a tendency towards higher values of volumetric wear in large heads that warrants longer-term evaluation before any definite conclusions about the association between head size and wear can be drawn. Cite this article: Bone Joint J 2021;103-B(7):1206–1214


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 855 - 863
1 May 2021
Koster LA Meinardi JE Kaptein BL Van der Linden - Van der Zwaag E Nelissen RGHH

Aims. The objective of this study was to compare the two-year migration pattern and clinical outcomes of a total knee arthroplasty (TKA) with an asymmetrical tibial design (Persona PS) and a well-proven TKA with a symmetrical tibial design (NexGen LPS). Methods. A randomized controlled radiostereometric analysis (RSA) trial was conducted including 75 cemented posterior-stabilized TKAs. Implant migration was measured with RSA. Maximum total point motion (MTPM), translations, rotations, clinical outcomes, and patient-reported outcome measures (PROMs) were assessed at one week postoperatively and at three, six, 12, and 24 months postoperatively. Results. A linear mixed-effect model using RSA data of 31 asymmetrical and 38 symmetrical TKAs did not show a difference in mean MTPM migration pattern of the tibial or femoral components. Mean tibial component MTPM at two years postoperative of the asymmetrical TKA design was 0.93 mm and 1.00 mm for the symmetrical design. For the femoral component these values were 1.04 mm and 1.14 mm, respectively. No significant differences were observed in other migration parameters or in clinical and PROM measurements. Conclusion. The TKA design with an asymmetrical tibial component has comparable component migration with the proven TKA with a symmetrical tibial component. This suggests the risk of long-term aseptic loosening of the two designs is comparable. Cite this article: Bone Joint J 2021;103-B(5):855–863


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 644 - 649
1 Apr 2021
Alsousou J Oragu E Martin A Strickland L Newman S Kendrick B Taylor A Glyn-Jones S

Aims. The aim of this prospective cohort study was to evaluate the early migration of the TriFit cementless proximally coated tapered femoral stem using radiostereometric analysis (RSA). Methods. A total of 21 patients (eight men and 13 women) undergoing primary total hip arthroplasty (THA) for osteoarthritis of the hip were recruited in this study and followed up for two years. Two patients were lost to follow-up. All patients received a TriFit stem and Trinity Cup with a vitamin E-infused highly cross-linked ultra-high molecular weight polyethylene liner. Radiographs for RSA were taken postoperatively and then at three, 12, and 24 months. Oxford Hip Score (OHS), EuroQol five-dimension questionnaire (EQ-5D), and adverse events were reported. Results. At two years, the mean subsidence of the head and tip for the TriFit stem was 0.38 mm (SD 0.32) and 0.52 mm (SD 0.36), respectively. The total migration of the head and tip was 0.55 mm (SD 0.32) and 0.71 mm (SD 0.38), respectively. There were no statistically significant differences between the three to 12 months' migration (p = 0.105) and 12 to 24 months' migration (p = 0.694). The OHS and EQ-5D showed significant improvements at two years. Conclusion. The results of this study suggest that the TriFit femoral stem achieves initial stability and is likely to be stable in the mid and long term. A long-term outcome study is required to assess late mechanisms of failure and the effects of bone mineral density (BMD) related changes. Cite this article: Bone Joint J 2021;103-B(4):644–649


Bone & Joint Open
Vol. 1, Issue 10 | Pages 653 - 662
20 Oct 2020
Rahman L Ibrahim MS Somerville L Teeter MG Naudie DD McCalden RW

Aims. To compare the in vivo long-term fixation achieved by two acetabular components with different porous ingrowth surfaces using radiostereometric analysis (RSA). Methods. This was a minimum ten-year follow-up of a prospective randomized trial of 62 hips with two different porous ingrowth acetabular components. RSA exams had previously been acquired through two years of follow-up. Patients returned for RSA examination at a minimum of ten years. In addition, radiological appearance of these acetabular components was analyzed, and patient-reported outcome measures (PROMs) obtained. Results. In all, 15 hips were available at ten years. There was no statistically significant difference in PROMS between the two groups; PROMs were improved at ten years compared to preoperative scores. Conventional radiological assessment revealed well-fixed components. There was minimal movement for both porous surfaces in translation (X, Y, Z, 3D translation in mm (median and interquartile range (IQR)), StikTite (Smith and Nephew, Memphis, Tennessee, USA): 0.03 (1.08), 0.12 (0.7), 0.003 (2.3), 0.37 (0.30), and Roughcoat (Smith and Nephew): -0.6 (0.59),–0.1 (0.49), 0.1 (1.12), 0.48 (0.38)), and rotation (X, Y, Z rotation in degrees (median and IQR), (Stiktite: -0.4 (3), 0.28 (2), -0.2 (1), and Roughcoat: - 0.4 (1),–0.1 (1), 0.2 (2)). There was no statistically significant difference between the two cohorts (p-value for X, Y, Z, 3D translation - 0.54, 0.46, 0.87, 0.55 and for X, Y, Z rotation - 0.41, 0.23, 0.23 respectively) at ten years. There was significant correlation between two years and ten years 3D translation for all components (r = 0.81(p =< 0.001)). Conclusion. Both porous ingrowth surfaces demonstrated excellent fixation on plain radiographs and with RSA at ten years. Short-term RSA data are good predictors for long-term migration data


The Bone & Joint Journal
Vol. 101-B, Issue 10 | Pages 1192 - 1198
1 Oct 2019
Sköldenberg OG Rysinska AD Chammout G Salemyr M Mukka SS Bodén H Eisler T

Aims. Radiostereometric analysis (RSA) studies of vitamin E-doped, highly crosslinked polyethylene (VEPE) liners show low head penetration rates in cementless acetabular components. There is, however, currently no data on cemented VEPE acetabular components in total hip arthroplasty (THA). The aim of this study was to evaluate the safety of a new cemented VEPE component, compared with a conventional polyethylene (PE) component regarding migration, head penetration, and clinical results. Patients and Methods. We enrolled 42 patients (21 male, 21 female) with osteoarthritis and a mean age of 67 years (. sd. 5), in a double-blinded, noninferiority, randomized controlled trial. The subjects were randomized in a 1:1 ratio to receive a reverse hybrid THA with a cemented component of either argon-gas gamma-sterilized PE component (controls) or VEPE, with identical geometry. The primary endpoint was proximal implant migration of the component at two years postoperatively measured with RSA. Secondary endpoints included total migration of the component, penetration of the femoral head into the component, and patient-reported outcome measurements. Results. In total, 19 control implants and 18 implants in the VEPE group were analyzed for the primary endpoint. We found a continuous proximal migration of the component in the VEPE group that was significantly higher with a difference at two years of a mean 0.21 mm (95% confidence interval (CI) 0.05 to 0.37; p = 0.013). The total migration was also significantly higher in the VEPE group, but femoral head penetration was lower. We found no difference in clinical outcomes between the groups. Conclusion. At two years, this cemented VEPE component, although having a low head penetration and excellent clinical results, failed to meet noninferiority compared with the conventional implant by a proximal migration above the proposed safety threshold of RSA. The early proximal migration pattern of the VEPE component is a reason for continued monitoring, although a specific threshold for proximal migration and risk for later failure cannot be defined and needs further study. Cite this article: Bone Joint J 2019;101-B:1192–1198


The Bone & Joint Journal
Vol. 101-B, Issue 7 | Pages 760 - 767
1 Jul 2019
Galea VP Rojanasopondist P Laursen M Muratoglu OK Malchau H Bragdon C

Aims. Vitamin E-diffused, highly crosslinked polyethylene (VEPE) and porous titanium-coated (PTC) shells were introduced in total hip arthroplasty (THA) to reduce the risk of aseptic loosening. The purpose of this study was: 1) to compare the wear properties of VEPE to moderately crosslinked polyethylene; 2) to assess the stability of PTC shells; and 3) to report their clinical outcomes at seven years. Patients and Methods. A total of 89 patients were enrolled into a prospective study. All patients received a PTC shell and were randomized to receive a VEPE liner (n = 44) or a moderately crosslinked polyethylene (ModXLPE) liner (n = 45). Radiostereometric analysis (RSA) was used to measure polyethylene wear and component migration. Differences in wear were assessed while adjusting for body mass index, activity level, acetabular inclination, anteversion, and head size. Plain radiographs were assessed for radiolucency and patient-reported outcome measures (PROMs) were administered at each follow-up. Results. In total, 73 patients (82%) completed the seven-year visit. Mean seven-year linear proximal penetration was -0.07 mm (. sd. 0.16) and 0.00 mm (. sd. 0.22) for the VEPE and ModXLPE cohorts, respectively (p = 0.116). PROMs (p = 0.310 to 0.807) and radiolucency incidence (p = 0.330) were not different between the polyethylene cohorts. The mean proximal shell migration rate was 0.04 mm per year (. sd. 0.09). At seven years, patients with radiolucency (34%) demonstrated greater migration (mean difference: 0.6 mm (. sd. 0.2); p < 0.001). PROMs were lower for patients with radiolucency and greater proximal migration (p = 0.009 to p = 0.045). No implants were revised for aseptic loosening. Conclusion. This is the first randomized controlled trial to report seven-year RSA results for VEPE. All wear rates were below the previously reported osteolysis threshold (0.1 mm per year). PTC shells demonstrated acceptable primary stability through seven years, as indicated by low migration and lack of aseptic loosening. However, patients with acetabular radiolucency were associated with higher shell migration and lower PROM scores. Cite this article: Bone Joint J 2019;101-B:760–767


The Bone & Joint Journal
Vol. 103-B, Issue 1 | Pages 98 - 104
1 Jan 2021
van Ooij B Sierevelt IN van der Vis HM Hoornenborg D Haverkamp D

Aims. For many designs of total knee arthroplasty (TKA) it remains unclear whether cemented or uncemented fixation provides optimal long-term survival. The main limitation in most studies is a retrospective or non-comparative study design. The same is true for comparative trials looking only at the survival rate as extensive sample sizes are needed to detect true differences in fixation and durability. Studies using radiostereometric analysis (RSA) techniques have shown to be highly predictive in detecting late occurring aseptic loosening at an early stage. To investigate the difference in predicted long-term survival between cemented, uncemented, and hybrid fixation of TKA, we performed a randomized controlled trial using RSA. Methods. A total of 105 patients were randomized into three groups (cemented, uncemented, and hybrid fixation of the ACS Mobile Bearing (ACS MB) knee system, implantcast). RSA examinations were performed on the first day after surgery and at scheduled follow-up visits at three months, six months, one year, and two years postoperatively. Patient-reported outcome measures (PROMs) were obtained preoperatively and after two years follow-up. Patients and follow-up investigators were blinded for the result of randomization. Results. RSA secondary stabilization did not show a significant difference between the three types of fixation. A maximum total point motion of less than 0.2 mm in the second postoperative year was shown in each group, which suggests stabilization of the implant. At 24 months after surgery, PROMs significantly improved compared to baseline in all treatment groups. No significant difference was observed between the three groups. Conclusion. Secondary stabilization measurements in this study demonstrated no significant difference between the groups. In all groups migration stabilized after initial settling of the implant. For this implant the long-term outcome is not expected to be influenced by the type of fixation to the bone. Cite this article: Bone Joint J 2021;103-B(1):98–104


Aims. Vitamin E-infused highly crosslinked polyethylene (VEPE) has been introduced into total hip arthroplasty (THA) with the aim of further improving the wear characteristics of moderately and highly crosslinked polyethylenes (ModXLPE and HXLPE). There are few studies analyzing the outcomes of vitamin E-infused components in cemented arthroplasty, though early acetabular component migration has been reported. The aim of this study was to measure five-year polyethylene wear and acetabular component stability of a cemented VEPE acetabular component compared with a ModXLPE cemented acetabular component. Methods. In a prospective randomized controlled trial (RCT), we assessed polyethylene wear and acetabular component stability (primary outcome) with radiostereometric analysis (RSA) in 68 patients with reverse hybrid THA at five years follow-up. Patients were randomized to either a VEPE or a ModXLPE cemented acetabular component. Results. Mean polyethylene wear in the proximal direction was 0.17 mm (SD 0.15) for the VEPE group and 0.20 mm (SD 0.09) for the ModXLPE group (p = 0.005) at five years. Annual proximal wear rates were 0.03 mm/year (VEPE) and 0.04 mm/year (ModXLPE). Total 3D wear was 0.21 mm (SD 0.26) and 0.23 mm (SD 0.10) for the VEPE and ModXLPE groups, respectively (p = 0.009). Total 3D cup translation was 0.72 mm (SD 0.70) (VEPE) and 0.50 mm (SD 0.44) (ModXLPE) (p = 0.409). Conclusion. At five years, there was less polyethylene wear in the VEPE group than in the ModXLPE group. Both VEPE and ModXLPE cemented components showed low annual wear rates. Component stability was similar in the two groups and remained constant up to five years. Whether these results will equate to a lower long-term revision rate is still unknown. Cite this article: Bone Joint J 2020;102-B(12):1646–1653


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 132 - 132
4 Apr 2023
Callary S Abrahams J Zeng Y Clothier R Costi K Campbell D Howie D Solomon L
Full Access

First-time revision acetabular components have a 36% re-revision rate at 10 years in Australia, with subsequent revisions known to have even worse results. Acetabular component migration >1mm at two years following revision THA is a surrogate for long term loosening. This study aimed to measure the migration of porous tantalum components used at revision surgery and investigate the effect of achieving press-fit and/or three-point fixation within acetabular bone. Between May 2011 and March 2018, 55 patients (56 hips; 30 female, 25 male) underwent acetabular revision THR with a porous tantalum component, with a post-operative CT scan to assess implant to host bone contact achieved and Radiostereometric Analysis (RSA) examinations on day 2, 3 months, 1 and 2 years. A porous tantalum component was used because the defects treated (Paprosky IIa:IIb:IIc:IIIa:IIIb; 2:6:8:22:18; 13 with pelvic discontinuity) were either deemed too large or in a position preventing screw fixation of an implant with low coefficient of friction. Press-fit and three-point fixation of the implant was assessed intra-operatively and on postoperative imaging. Three-point acetabular fixation was achieved in 51 hips (92%), 34 (62%) of which were press-fit. The mean implant to host bone contact achieved was 36% (range 9-71%). The majority (52/56, 93%) of components demonstrated acceptable early stability. Four components migrated >1mm proximally at two years (1.1, 3.2, 3.6 and 16.4mm). Three of these were in hips with Paprosky IIIB defects, including 2 with pelvic discontinuity. Neither press-fit nor three-point fixation was achieved for these three components and the cup to host bone contact achieved was low (30, 32 and 59%). The majority of porous tantalum components had acceptable stability at two years following revision surgery despite treating large acetabular defects and poor bone quality. Components without press-fit or three-point fixation were associated with unacceptable amounts of early migration


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1654 - 1661
1 Dec 2020
Perelgut ME Polus JS Lanting BA Teeter MG

Aims. The direct anterior (DA) approach has been associated with rapid patient recovery after total hip arthroplasty (THA) but may be associated with more frequent femoral complications including implant loosening. The objective of this study was to determine whether the addition of a collar to the femoral stem affects implant migration, patient activity, and patient function following primary THA using the DA approach. Methods. Patients were randomized to either a collared (n = 23) or collarless (n = 26) cementless femoral stem implanted using the DA approach. Canal fill ratio (CFR) was measured on the first postoperative radiographs. Patients underwent a supine radiostereometric analysis (RSA) exam postoperatively on the day of surgery and at two, four, six, 12, 26, and 52 weeks postoperatively. Patient-reported outcome measures (Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, the 12-item Short Form Health Survey Mental and Physical Score, and University of California, Los Angeles (UCLA) Activity Score) were measured preoperatively and at each post-surgery clinic visit. Activity and function were also measured as the weekly average step count recorded by an activity tracker, and an instrumented timed up-and-go (TUG) test in clinic, respectively. Results. Comparing the RSA between the day of surgery baseline exam to two weeks postoperatively, subsidence was significantly lower (mean difference 2.23 mm (SD 0.71), p = 0.023) with collared stems, though these patients had a greater CFR (p = 0.048). There was no difference (p = 0.426) in subsidence between stems from a two-week baseline through to one year postoperatively. There were no clinically relevant differences in PROMs; and there was no difference in the change in activity (p = 0.078) or the change in functional capacity (p = 0.664) between the collared stem group and the collarless stem group at any timepoint. Conclusion. Presence of a collar on the femoral stem resulted in reduced subsidence during the first two postoperative weeks following primary THA using the DA approach. However, the clinical implications are unclear, and larger studies examining patient activity and outcomes are required. Cite this article: Bone Joint J 2020;102-B(12):1654–1661


Abstract. Introduction. Cementless fixation of Oxford Unicompartmental Knee Replacements (UKRs) is an alternative to cemented fixation, however, it is unknown whether cementless fixation is as good long-term. This study aimed to compare primary and long-term fixation of cemented and cementless Oxford UKRs using radiostereometric analysis (RSA). Methodology. Twenty-nine patients were randomised to receive cemented or cementless Oxford UKRs and followed for ten years. Differences in primary fixation and long-term fixation of the tibial components (inferred from 0/3/6-month and 6-month/1-year/2-year/5-year/10-year migration, respectively) were analysed using RSA and radiolucencies were assessed on radiographs. Migration rates were determined by linear regression and clinical outcomes measured using the Oxford Knee Score (OKS). Results. Preliminary analysis of Maximum Total Point Motion (MTPM) indicated cementless tibial components undergo significantly more migration than cemented components during the first 6 months (1.6mm/year, SD=0.92 versus 1.3mm/year, SD=1.1, p<0.001). Cementless migration was predominantly subsidence inferiorly (Mean=0.51mm/year, SD=0.29, p<0.001) and posteriorly (0.13mm/year, SD=0.21, p=0.03). Contrastingly, from 6 months to 10 years cemented components migrated significantly (MTPM=0.039mm/year, SD=0.11, p=0.04) whereas cementless components did not (MTPM=0.002mm/year, SD=0.02, p=0.744). Radiolucent lines occurred more frequently below cemented (10/13) than cementless (4/16) tibial components, but radiolucencies did not correlate with differences in migration or OKS. There was no significant difference in OKS between cemented and cementless. Conclusion. These results suggest that cementless tibial components migrate more than cemented before achieving primary fixation. However, long-term fixation of cementless tibial components appears to be as good, if not better, than cemented with the benefit of fewer radiolucent lines


The Bone & Joint Journal
Vol. 102-B, Issue 8 | Pages 1016 - 1024
1 Aug 2020
Hasan S van Hamersveld KT Marang-van de Mheen PJ Kaptein BL Nelissen RGHH Toksvig-Larsen S

Aims. Although bone cement is the primary mode of fixation in total knee arthroplasty (TKA), cementless fixation is gaining interest as it has the potential of achieving lasting biological fixation. By 3D printing an implant, highly porous structures can be manufactured, promoting osseointegration into the implant to prevent aseptic loosening. This study compares the migration of cementless, 3D-printed TKA to cemented TKA of a similar design up to two years of follow-up using radiostereometric analysis (RSA) known for its ability to predict aseptic loosening. Methods. A total of 72 patients were randomized to either cementless 3D-printed or a cemented cruciate retaining TKA. RSA and clinical scores were evaluated at baseline and postoperatively at three, 12, and 24 months. A mixed model was used to analyze the repeated measurements. Results. The mean maximum total point motion (MTPM) at three, 12, and 24 months was 0.33 mm (95% confidence interval (CI) 0.25 to 0.42), 0.42 mm (95% CI 0.33 to 0.51), and 0.47 mm (95% CI 0.38 to 0.57) respectively in the cemented group, versus 0.52 mm (95% CI 0.43 to 0.63), 0.62 mm (95% CI 0.52 to 0.73), and 0.64 mm (95% CI 0.53 to 0.75) in the cementless group (p = 0.003). However, using three months as baseline, no difference in mean migration between groups was found (p = 0.497). Three implants in the cemented group showed a > 0.2 mm increase in MTPM between one and two years of follow-up. In the cementless group, one implant was revised due to pain and progressive migration, and one patient had a liner-exchange due to a deep infection. Conclusion. The cementless TKA migrated more than the cemented TKA in the first two-year period. This difference was mainly due to a higher initial migration of the cementless TKA in the first three postoperative months after which stabilization was observed in all but one malaligned and early revised TKA. Whether the biological fixation of the cementless implants will result in an increased long-term survivorship requires a longer follow-up. Cite this article: Bone Joint J 2020;102-B(8):1016–1024


The Bone & Joint Journal
Vol. 105-B, Issue 11 | Pages 1168 - 1176
1 Nov 2023
Yüksel Y Koster LA Kaptein BL Nelissen RGHH den Hollander P

Aims. Conflicting clinical results are reported for the ATTUNE Total Knee Arthroplasty (TKA). This randomized controlled trial (RCT) evaluated five-year follow-up results comparing cemented ATTUNE and PFC-Sigma cruciate retaining TKAs, analyzing component migration as measured by radiostereometric analysis (RSA), clinical outcomes, patient-reported outcome measures (PROMs), and radiological outcomes. Methods. A total of 74 primary TKAs were included in this single-blind RCT. RSA examinations were performed, and PROMs and clinical outcomes were collected immediate postoperatively, and at three, six, 12, 24, and 60 months’ follow-up. Radiolucent lines (RLLs) were measured in standard anteroposterior radiographs at six weeks, and 12 and 60 months postoperatively. Results. At five-year follow-up, RSA data from 61 patients were available and the mean maximum total point motion (MTPM) of the femoral components were: ATTUNE: 0.96 mm (95% confidence interval (CI) 0.79 to 1.14) and PFC-Sigma 1.37 mm (95% CI 1.18 to 1.59) (p < 0.001). The PFC-Sigma femoral component migrated more in the first postoperative year, but stabilized thereafter. MPTM of the tibial components were comparable at five-year follow-up: ATTUNE 1.12 mm (95% CI 0.95 to 1.31) and PFC-Sigma 1.25 mm (95% CI 1.07 to 1.44) (p = 0.438). RLL at the medial tibial implant-cement interface remained more prevalent for the ATTUNE at five-year follow-up compared to the PFC-Sigma (20% vs 3%). RLL did not progress over time, and varied between patients at different timepoints for both TKA systems. Clinical outcomes and PROMs improved compared with preoperative scores, and were not different between groups. Conclusion. MTPM migration at five-year follow-up of the femoral and tibial component of the ATTUNE were similar and as low as that of the PFC-Sigma. MTPM migration of both knee implants did not significantly change from one year post-surgery, indicating stable fixation. Long-term ATTUNE performance may be expected to be comparable to the clinically well-performing PFC-Sigma. We have not found evidence of increased tibial component migration as measured by RSA to support concerns about cement debonding and a higher risk of aseptic loosening with the ATTUNE TKA. Cite this article: Bone Joint J 2023;105-B(11):1168–1176


The Bone & Joint Journal
Vol. 101-B, Issue 5 | Pages 565 - 572
1 May 2019
Teeter MG Marsh JD Howard JL Yuan X Vasarhelyi EM McCalden RW Naudie DDR

Aims. The purpose of the present study was to compare patient-specific instrumentation (PSI) and conventional surgical instrumentation (CSI) for total knee arthroplasty (TKA) in terms of early implant migration, alignment, surgical resources, patient outcomes, and costs. . Patients and Methods. The study was a prospective, randomized controlled trial of 50 patients undergoing TKA. There were 25 patients in each of the PSI and CSI groups. There were 12 male patients in the PSI group and seven male patients in the CSI group. The patients had a mean age of 69.0 years (. sd. 8.4) in the PSI group and 69.4 years (. sd. 8.4) in the CSI group. All patients received the same TKA implant. Intraoperative surgical resources and any surgical waste generated were recorded. Patients underwent radiostereometric analysis (RSA) studies to measure femoral and tibial component migration over two years. Outcome measures were recorded pre- and postoperatively. Overall costs were calculated for each group. Results. There were no differences (p > 0.05) in any measurement of migration at two years for either the tibial or femoral components. Movement between one and two years was < 0.2 mm, indicating stable fixation. There were no differences in coronal or sagittal alignment between the two groups. The PSI group took a mean 6.1 minutes longer (p = 0.04) and used a mean 3.4 less trays (p < 0.0001). Total waste generated was similar (10 kg) between the two groups. The PSI group cost a mean CAD$1787 more per case (p < 0.01). Conclusion. RSA criteria suggest that both groups will have revision rates of approximately 3% at five years. The advantages of PSI were minimal or absent for surgical resources used and waste eliminated, and for meeting target alignment, yet had significantly greater costs. Therefore, we conclude that PSI may not offer any advantage over CSI for routine primary TKA cases. Cite this article: Bone Joint J 2019;101-B:565–572


The Bone & Joint Journal
Vol. 96-B, Issue 5 | Pages 604 - 608
1 May 2014
von Schewelov T Carlsson Å Sanzén L Besjakov J

In 2005, we demonstrated that the polished triple-tapered C-stem at two years had migrated distally and rotated internally. From that series, 33 patients have now been followed radiologically, clinically and by radiostereometric analysis (RSA) for up to ten years. The distal migration within the cement mantle had continued and reached a mean of 2 mm (0.5 to 4.0) at ten years. Internal rotation, also within the cement mantle, was a mean 3.8° (external 1.6° to internal 6.6°) The cement mantle did not show any sign of migration or loosening in relation to the femoral bone. There were no clinical or radiological signs indicating that the migration or rotation within the cement mantle had had any adverse effects for the patients. Cite this article: Bone Joint J 2014;96-B:604–8


Bone & Joint Research
Vol. 7, Issue 6 | Pages 379 - 387
1 Jun 2018
Hansen L De Raedt S Jørgensen PB Mygind-Klavsen B Kaptein B Stilling M

Objectives. To validate the precision of digitally reconstructed radiograph (DRR) radiostereometric analysis (RSA) and the model-based method (MBM) RSA with respect to benchmark marker-based (MM) RSA for evaluation of kinematics in the native hip joint. Methods. Seven human cadaveric hemipelves were CT scanned and bone models were segmented. Tantalum beads were placed in the pelvis and proximal femoral bone. RSA recordings of the hips were performed during flexion, adduction and internal rotation. Stereoradiographic recordings were all analyzed with DRR, MBM and MM. Migration results for the MBM and DRR with respect to MM were compared. Precision was assessed as systematic bias (mean difference) and random variation (Pitman’s test for equal variance). Results. A total of 288 dynamic RSA images were analyzed. Systematic bias for DRR and MBM with respect to MM in translations (p < 0.018 mm) and rotations (p < 0.009°) were approximately 0. Pitman’s test showed lower random variation in all degrees of freedom for DRR compared with MBM (p < 0.001). Conclusion. Systematic error was approximately 0 for both DRR or MBM. However, precision of DRR was statistically significantly better than MBM. Since DRR does not require marker insertion it can be used for investigation of preoperative hip kinematics in comparison with the postoperative results after joint preserving hip surgery. . Cite this article: L. Hansen, S. De Raedt, P. B. Jørgensen, B. Mygind-Klavsen, B. Kaptein, M. Stilling. Marker free model-based radiostereometric analysis for evaluation of hip joint kinematics: A validation study. Bone Joint Res 2018;7:379–387. DOI: 10.1302/2046-3758.76.BJR-2017-0268.R1


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_4 | Pages 10 - 10
1 Apr 2022
Fontalis A Hansjee S Vanhegan I Ahmad SA Ogilvie A Giebaly D Kayani B Haddad FS
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Cementless stem designs in total hip arthroplasty differ in relation to geometry and area of fixation. We utilised radiostereometric analysis (RSA) to evaluate the 2-year migration of a novel, short, proximally coated femoral stem. 30 participants undergoing primary total hip replacement for any cause (rheumatoid or inflammatory arthritis, osteoarthritis) were prospectively recruited in this study. Osteoporotic patients and cases of suspected infection were excluded. All patients received a short blade stem, proximally coated with a reduced lateral shoulder and narrow triple taper geometry to minimise bone removal. RSA radiographs were performed post-operatively and at 6 weeks, 6 months, 1- and 2 years. The Harris Hip Score (HHS), Oxford Hip Score (OHS) and EQ-5D were collected at baseline and at 2 years post-operatively. The stability of implants and complications were captured during each follow-up visit. A total of 14 female and 16 male patients were recruited with a mean age of 64.8 (range 47 to 75). At two years the mean subsidence of the stem was 0.34 mm (SD 0.62) and the total migration 0.74 mm (SD 0.60). The mean medial translation at two years was 0.059 (0.24) and the mean anterior translation 0.12 (0.59) respectively. Baseline PROM scores improved significantly at 2-years from pre-operatively (median and interquartile range): HHS from 33 (18.25) to 92 (19), EQ5D from 0.5 (0.35) to 0.94 (0.17), OHS from 21 (18.25) to 42 (4.25). P-value for all comparisons was <0.001. 2-year follow up data revealed no complications. There were no stem revisions in study participants and no heterotopic ossifications were identified on radiographs. 2-year migration results of a cementless, short blade, proximally coated tapered femoral stem using RSA, showed the stem exhibits a predictable migration pattern and achieves initial stability. This is highly likely to translate to mid and long-term stability, which needs to be corroborated by long-term outcome studies. Furthermore, participants demonstrated excellent clinical, patient reported and radiological outcomes after 2 years of follow up to support expansion in the use of this prosthesis


The Bone & Joint Journal
Vol. 100-B, Issue 12 | Pages 1579 - 1584
1 Dec 2018
Turgeon TR Gascoyne TC Laende EK Dunbar MJ Bohm ER Richardson CG

Aims. The introduction of a novel design of total knee arthroplasty (TKA) must achieve outcomes at least as good as existing designs. A novel design of TKA with a reducing radius of the femoral component and a modified cam-post articulation has been released and requires assessment of the fixation to bone. Radiostereometric analysis (RSA) of the components within the first two postoperative years has been shown to be predictive of medium- to long-term fixation. The aim of this study was to assess the stability of the tibial component of this system during this period of time using RSA. Patients and Methods. A cohort of 30 patients underwent primary, cemented TKA using the novel posterior stabilized fixed-bearing (ATTUNE) design. There was an even distribution of men and women (15:15). The mean age of the patients was 64 years (sd 8) at the time of surgery; their mean body mass index (BMI) was 35.4 kg/m2 (sd 7.9). RSA was used to assess the stability of the tibial component at 6, 12, and 24 months compared with a six-week baseline examination. Patient-reported outcome measures were also assessed. Results. The mean maximum total point motion (MTPM) of the tibial component between 12 and 24 months postoperatively was 0.08 mm (sd 0.08), which is well below the published threshold of 0.2 mm (p < 0.001). Patient-reported outcome measures consistently improved. Conclusion. The tibial component of this novel design of TKA showed stability between assessment 12 and 24 months postoperatively, suggesting an acceptably low risk of medium- to long-term failure due to aseptic loosening


The Bone & Joint Journal
Vol. 101-B, Issue 7_Supple_C | Pages 55 - 60
1 Jul 2019
Laende EK Richardson CG Dunbar MJ

Aims. Early implant migration measured with radiostereometric analysis (RSA) has been proposed as a useful predictor of long-term fixation of tibial components in total knee arthroplasty. Evaluation of actual long-term fixation is of interest for cemented components, as well as for cementless fixation, which may offer long-term advantages once osseointegration has occurred. The objective of this study was to compare the long-term migration with one- and two-year migration to evaluate the predictive ability of short-term migration data and to compare migration and inducible displacement between cemented and cementless (porous metal monoblock) components at least ten years postoperatively. Patients and Methods. Patients who had participated in RSA migration studies with two-year follow-up were recruited to return for a long-term follow-up, at least ten years from surgery. Two cemented tibial designs from two manufacturers and one porous metal monoblock cementless tibial design were studied. At the long-term follow-up, patients had supine RSA examinations to determine migration and loaded examinations (single leg stance) to determine inducible displacement. In total, 79 patients (54 female) returned, with mean time since surgery of 12 years (10 to 14). There were 58 cemented and 21 cementless tibial components. Results. Migration at one year and two years was significantly correlated with long-term migration (p < 0.001). Median migration at the long-term follow-up was 0.6 mm (maximum total point motion; interquartile range (IQR) 0.4 to 0.9) for the cemented group and 0.6 mm. (IQR 0.3 to 1.1) for the cementless group with no difference between groups (p = 0.99). Inducible displacement was significantly lower for the cementless components (p < 0.001). Conclusion. Long-term migration was strongly correlated with two-year migration. Although long-term migration was not different for cemented or cementless tibial components, inducible displacement at the long-term visit was significantly lower for these cementless components, suggesting superior fixation. These findings support the predictive value of short-term migration in determining long-term fixation. Cite this article: Bone Joint J 2019;101-B(7 Supple C):55–60


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_14 | Pages 43 - 43
1 Nov 2021
Callary S Abrahams J Zeng Y Clothier R Costi K Campbell D Howie D Solomon L
Full Access

First-time revision acetabular components have a 36% re-revision rate at 10 years in Australia, with subsequent revisions known to have even worse results. Acetabular component migration >1mm at two years following revision THA is a surrogate for long term loosening. This study aimed to measure the migration of porous tantalum components used at revision surgery and investigate the effect of achieving press-fit and/or three-point fixation within acetabular bone. Between May 2011 and March 2018, 55 patients (56 hips; 30 female, 25 male) underwent acetabular revision THR with a porous tantalum component, with a post-operative CT scan to assess implant to host bone contact achieved and Radiostereometric Analysis (RSA) examinations on day 2, 3 months, 1 and 2 years. A porous tantalum component was used because the defects treated (Paprosky IIa:IIb:IIc:IIIa:IIIb; 2:6:8:22:18; 13 with pelvic discontinuity) were either deemed too large or in a position preventing screw fixation of an implant with low coefficient of friction. Press-fit and three-point fixation of the implant was assessed intra-operatively and on postoperative imaging. Three-point acetabular fixation was achieved in 51 hips (92%), 34 (62%) of which were press-fit. The mean implant to host bone contact achieved was 36% (range 9–71%). The majority (52/56, 93%) of components demonstrated acceptable early stability. Four components migrated >1mm proximally at two years (1.1, 3.2, 3.6 and 16.4mm). Three of these were in hips with Paprosky IIIB defects, including 2 with pelvic discontinuity. Neither press-fit nor three-point fixation was achieved for these three components and the cup to host bone contact achieved was low (30, 32 and 59%). The majority of porous tantalum components had acceptable stability at two years following revision surgery despite treating large acetabular defects and poor bone quality. Components without press-fit or three-point fixation were associated with unacceptable amounts of early migration


The Bone & Joint Journal
Vol. 99-B, Issue 3 | Pages 317 - 324
1 Mar 2017
Schilcher J Palm L Ivarsson I Aspenberg P

Aims. Post-operative migration of cemented acetabular components as measured by radiostereometric analysis (RSA) has a strong predictive power for late, aseptic loosening. Also, radiolucent lines predict late loosening. Migration has been reduced by systemic bisphosphonate treatment in randomised trials of hip and knee arthroplasty. Used as a local treatment, a higher local dose of bisphosphonate can be achieved without systemic exposure. We wished to see if this principle could be applied usefully in total hip arthroplasty (THA). Patients and Methods. In this randomised placebo-controlled, double-blinded trial with 60 participants, we compressed gauze soaked in bisphosphonate solution (ibandronate) or saline against the acetabular bone bed immediately before cementing the acetabular component. RSA, classification of radiolucent lines, the Harris Hip Score (HHS) and the Western Ontario McMasters Universities Osteoarthritis Index (WOMAC) were carried out at three-, six-, 12-, and 24-month follow-up. Results. Migration of the cemented acetabular component relative to the pelvis was reduced by movement almost half in the ibandronate group, when measured as maximum total point or as movement of the femoral head (p = 0.001 and 0.004, respectively). Radiolucent lines after one year were classified as absent, partial or complete, and correlated with treatment (rho 0.37; p = 0.004). Only three of 30 patients in the ibandronate group had complete lines, compared with 13 of 28 in the placebo group (p = 0.002). There were no significant effects on HHS or WOMAC score. Conclusion. Considering the power of RSA to predict loosening of cemented acetabular components, and the likelihood that radiolucent lines indicate risk of loosening, these data suggest that local treatment with a bisphosphonate can reduce the risk of late aseptic loosening. Cite this article: Bone Joint J 2017;99-B:317–24


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_14 | Pages 16 - 16
1 Nov 2021
McCalden R Salipas A Teeter M Somerville L Naudie D MacDonald S
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The purpose of this study was to precisely measure the 10-year polyethylene wear rate of primary total hips using Radiostereometric analysis (RSA) comparing Oxidized Zirconium (OxZi) to cobalt chrome (CoCr) femoral heads articulating with highly cross-linked polyethylene (XLPE). RSA was performed on 46 patients who underwent total hip arthroplasty − 23 who received OxZi femoral heads and 23 who received CoCr heads in combination with XLPE at a minimum of 10 years follow-up. All patients had identical THR systems implanted except for the femoral head utilized. The Centre Index method was utilised to assess total wear rates (from index surgery until final evaluation) using a dedicated RSA Software program (UmRSA Digital Measure v.2.2.1). In addition, the Martell technique was used to subtract head penetration occurring in the first 1–2 years (i.e. bedding-in phase) to allow calculation of the ‘steady state’ wear rates. There were no significant differences in demographics (i.e age, BMI, gender) between the groups. The average time from surgery of the RSA examinations was 11.7 and 12.6 years for the CoCr and OxZi groups respectively. Using the Centre Index Method to calculate total head penetration, wear rates were slightly higher in the OxZi group (0.048 +/− 0.021mm/year) compared to the CoCr group (0.035 +/− 0.017mm/year) with no statistical difference between the groups (p= 0.02). After correction for the bedding-in period, there was no statistically significant difference in mean ‘steady-state’ wear rate between OxZi (0.031 +/− 0.021mm/year) and CoCr (0.024 +/− 0.019mm/year) at 10 year follow up (p= 0.24). A comparison of preoperative and postoperative SF12, HHS, and WOMAC scores showed no statistical difference between the groups. RSA demonstrated the 10 year in-vivo wear rates of both bearing combinations to be well below the threshold for osteolysis. There was no significant difference between either the total or ‘steady-state’ wear rates of the OxZi and CoCr groups at 10 years


The Bone & Joint Journal
Vol. 100-B, Issue 2 | Pages 170 - 175
1 Feb 2018
Lam Tin Cheung K Lanting BA McCalden RW Yuan X MacDonald SJ Naudie DD Teeter MG

Aims. The aim of this study was to evaluate the long-term inducible displacement of cemented tibial components ten years after total knee arthroplasty (TKA). Patients and Methods. A total of 15 patients from a previously reported prospective trial of fixation using radiostereometric analysis (RSA) were examined at a mean of 11 years (10 to 11) postoperatively. Longitudinal supine RSA examinations were acquired at one week, one year, and two years postoperatively and at final follow-up. Weight-bearing RSA examinations were also undertaken with the operated lower limb in neutral and in maximum internal rotation positions. Maximum total point motion (MTPM) was calculated for the longitudinal and inducible displacement examinations (supine versus standing, standing versus internal rotation, and supine versus standing with internal rotation). Results. All patients showed some inducible displacement. Two patients with radiolucent lines had greater mean standing-supine MTPM displacement (1.35; . sd. 0.38) compared with the remaining patients (0.68; . sd. 0.36). These two patients also had a greater mean longitudinal MTPM at ten years (0.64; . sd. 0.50) compared with the remaining patients (0.39; . sd. 0.13 mm). Conclusion. Small inducible displacements in well-fixed cemented tibial components were seen ten years postoperatively, of a similar magnitude to that which has been reported for well-fixed components one to two years postoperatively. Greater displacements were found in components with radiolucent lines. Cite this article: Bone Joint J 2018;100-B:170–5


The Bone & Joint Journal
Vol. 100-B, Issue 12 | Pages 1592 - 1599
1 Dec 2018
Galea VP Connelly JW Shareghi B Kärrholm J Sköldenberg O Salemyr M Laursen MB Muratoglu O Bragdon C Malchau H

Aims. The primary aim of this study was to compare the wear properties of vitamin E-diffused, highly crosslinked polyethylene (VEPE) and one formulation of moderately crosslinked and mechanically annealed ultra-high molecular weight polyethylene (ModXLPE) in patients five years after primary total hip arthroplasty (THA). The secondary aim was to assess the clinical results of patients treated with VEPE by evaluating patient-reported outcome measures (PROMs), radiological evidence of fixation, and the incidence of mechanical failure. Patients and Methods. A total of 208 patients (221 THAs) from four international centres were recruited into a prospective study involving radiostereometric analysis (RSA) and the assessment of clinical outcomes. A total of 193 hips (87%) were reviewed at the five-year follow-up. Of these, 136 (70%) received VEPE (vs ModXLPE) liners and 68 (35%) received ceramic (vs metal) femoral heads. PROMs and radiographs were collected preoperatively and at one, two, and five years postoperatively. In addition, RSA images were collected to measure PE wear postoperatively and at one, two, and five years after surgery. Results. We observed similar bedding in one year postoperatively and wear two years postoperatively between the two types of liner. However, there was significantly more penetration of the femoral head in the ModXLPE cohort compared with the VEPE cohort five years postoperatively (p < 0.001). The only variables independently predictive of increased wear were ModXLPE (vs VEPE) liner type (β = 0.22, p = 0.010) and metal (vs ceramic) femoral head (β = 0.21, p = 0.013). There was no association between increased wear and the development of radiolucency (p = 0.866) or PROMs. No patient had evidence of osteolysis. Conclusion. Five years postoperatively, patients with VEPE (vs ModXLPE) and ceramic (vs metal) femoral heads had decreased wear. The rates of wear for both liners were very low and have not led to any osteolysis or implant failure due to aseptic loosening


The Bone & Joint Journal
Vol. 99-B, Issue 5 | Pages 674 - 679
1 May 2017
Nuttall D Birch A Haines JF Watts AC Trail IA

Aims. Radiostereometric analysis (RSA) allows an extremely accurate measurement of early micromotion of components following arthroplasty. . Patients and Methods. In this study, RSA was used to measure the migration of 11 partially cemented fluted pegged glenoid components in patients with osteoarthritis who underwent total shoulder arthroplasty using an improved surgical technique (seven men, four women, mean age 68). Patients were evaluated clinically using the American Shoulder and Elbow Surgeons (ASES) and Constant-Murley scores and by CT scans two years post-operatively. . Results. There were two patterns of migration, the first showing little, if any, migration and the second showing rotation by > 6° as early as three months post-operatively. At two years, these two groups could be confirmed on CT scans, one with osseointegration around the central peg, and the second with cystic changes. Patients with osteolysis around the central peg were those with early migration and those with osseointegration had minimal early migration. Both groups,however,had similar clinical results. . Conclusion. Rapid early migration associated with focal lucency and absence of osseointegration was observed in three of 11 glenoid components, suggesting that lack of initial stability leads to early movement and failure of osseointegration. Cite this article: Bone Joint J 2017;99-B:674–9


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_7 | Pages 11 - 11
1 May 2021
Skipsey DA Downing MR Ashcroft GP Cairns DA Kumar K
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Over the last decade stemless shoulder arthroplasty has become increasingly popular. However, stability of metaphyseal loading humeral components remains a concern. This study aimed to assess the stability of the Affinis stemless humeral component using Radiostereometric analysis (RSA). Patients underwent total shoulder arthroplasty via a standardised technique with a press-fit stemless humeral component and a cemented pegged glenoid. Tantalum beads were inserted into the humerus at the time of operation. RSA of the relaxed shoulder was completed at weeks 1, 6, 13, 26, 52 and 104 post-operatively. Stressed RSA with 12 newtons of abduction force was completed from week 13 onwards. ABRSA 5.0 software (Downing Imaging Limited, Aberdeen) was used to calculate humeral component migration and induced movement. 15 patients were recruited. Precision was: 0.041, 0.034, 0.086 and 0.101 mm for Superior, Medial, Posterior and Total Point Motion (TPM) respectively. The mean TPM over 2 years was 0.24 (0.30) mm, (Mean (Standard deviation)). The mean rate of migration per 3 month time period decreased from 0.45 (0.31) to 0.02 (0.01) mm over 2 years. Mean inducible movement TPM peaked at 26 weeks at 0.1 (0.08) mm, which reduced to 0.07 (0.06) mm by 104 weeks when only 3 patients had measurable inducible motion. There was no clear trend in direction of induced movement. There were no adverse events or revisions required. We conclude migration of the humeral component was low with little inducible movement in the majority of patients implying initial and 2 year stability of the stemless humeral component


The Bone & Joint Journal
Vol. 98-B, Issue 12 | Pages 1604 - 1610
1 Dec 2016
Callary SA Field JR Campbell DG

Aims. The increased in vivo resistance to wear of highly crosslinked polyethylene (HXLPE) in total hip arthroplasty (THA) has led to an increased use of larger articulations which have been shown to reduce the incidence of early dislocation. To date, there are few reports of the wear of larger articulations using second generation HXLPE liners. Our prospective cohort study measured the bedding-in and early wear of large (36 mm and 40 mm diameter) articulations involving a second generation X3 HXLPE liner and compared our findings with previous clinical and in vitro studies of the same material. Patients and Methods. The proximal penetration of the femoral head five years post-operatively was measured for 15 patients using radiostereometric analysis (RSA). Results. The median proximal bedding-in within the first post-operative year was 0.022 mm (interquartile range (IQR) -0.050 to 0.091). The median proximal rate of wear between one and five years was -0.004 mm/year (IQR -0.021 to 0.022). The rates of proximal, medial, 2D or 3D wear between one and five years post-operatively of the X3 HXLPE liner did not increase with larger articulations compared with our previous study of 32 mm articulations. Conclusion. Although reassuring, the use of larger articulations requires continued monitoring to determine whether the low wear observed in the short-term continues to the mid- to long-term. Cite this article: Bone Joint J 2016;98-B:1604–10


Bone & Joint Research
Vol. 5, Issue 6 | Pages 206 - 214
1 Jun 2016
Malak TT Broomfield JAJ Palmer AJR Hopewell S Carr A Brown C Prieto-Alhambra D Glyn-Jones S

Objectives. High failure rates of metal-on-metal hip arthroplasty implants have highlighted the need for more careful introduction and monitoring of new implants and for the evaluation of the safety of medical devices. The National Joint Registry and other regulatory services are unable to detect failing implants at an early enough stage. We aimed to identify validated surrogate markers of long-term outcome in patients undergoing primary total hip arthroplasty (THA). Methods. We conducted a systematic review of studies evaluating surrogate markers for predicting long-term outcome in primary THA. Long-term outcome was defined as revision rate of an implant at ten years according to National Institute of Health and Care Excellence guidelines. We conducted a search of Medline and Embase (OVID) databases. Separate search strategies were devised for the Cochrane database and Google Scholar. Each search was performed to include articles from the date of their inception to June 8, 2015. Results. Our search strategy identified 1082 studies of which 115 studies were included for full article review. Following review, 17 articles were found that investigated surrogate markers of long-term outcome. These included one systematic review, one randomised control trial (RCT), one case control study and 13 case series. Validated surrogate markers included Radiostereometric Analysis (RSA) and Einzel-Bild-Röntgen-Analyse (EBRA), each measuring implant migration and wear. We identified five RSA studies (one systematic review and four case series) and four EBRA studies (one RCT and three case series). Patient Reported Outcome Measures (PROMs) at six months have been investigated but have not been validated against long-term outcomes. Conclusions. This systematic review identified two validated surrogate markers of long-term primary THA outcome: RSA and EBRA, each measuring implant migration and wear. We recommend the consideration of RSA in the pre-market testing of new implants. EBRA can be used to investigate acetabular wear but not femoral migration. Further studies are needed to validate the use of PROMs for post-market surveillance. Cite this article: T. T. Malak, J. A. J. Broomfield, A. J. R. Palmer, S. Hopewell, A. Carr, C. Brown, D. Prieto-Alhambra, S. Glyn-Jones. Surrogate markers of long-term outcome in primary total hip arthroplasty: A systematic review. Bone Joint Res 2016;5:206–214. DOI: 10.1302/2046-3758.56.2000568


Bone & Joint Research
Vol. 6, Issue 6 | Pages 376 - 384
1 Jun 2017
Stentz-Olesen K Nielsen ET De Raedt S Jørgensen PB Sørensen OG Kaptein BL Andersen MS Stilling M

Objectives. Static radiostereometric analysis (RSA) using implanted markers is considered the most accurate system for the evaluation of prosthesis migration. By using CT bone models instead of markers, combined with a dynamic RSA system, a non-invasive measurement of joint movement is enabled. This method is more accurate than current 3D skin marker-based tracking systems. The purpose of this study was to evaluate the accuracy of the CT model method for measuring knee joint kinematics in static and dynamic RSA using the marker method as the benchmark. Methods. Bone models were created from CT scans, and tantalum beads were implanted into the tibia and femur of eight human cadaver knees. Each specimen was secured in a fixture, static and dynamic stereoradiographs were recorded, and the bone models and marker models were fitted to the stereoradiographs. Results. Results showed a mean difference between the two methods in all six degrees of freedom for static RSA to be within -0.10 mm/° and 0.08 mm/° with a 95% limit of agreement (LoA) ranging from ± 0.49 to 1.26. Dynamic RSA had a slightly larger range in mean difference of -0.23 mm/° to 0.16 mm/° with LoA ranging from ± 0.75 to 1.50. Conclusions. In a laboratory-controlled setting, the CT model method combined with dynamic RSA may be an alternative to previous marker-based methods for kinematic analyses. Cite this article: K. Stentz-Olesen, E. T. Nielsen, S. De Raedt, P. B. Jørgensen, O. G. Sørensen, B. L. Kaptein, M. S. Andersen, M. Stilling. Validation of static and dynamic radiostereometric analysis of the knee joint using bone models from CT data. Bone Joint Res 2017;6:376–384. DOI: 10.1302/2046-3758.66.BJR-2016-0113.R3


Bone & Joint Research
Vol. 4, Issue 5 | Pages 78 - 83
1 May 2015
Martinkevich P Rahbek O Møller-Madsen B Søballe K Stilling M

Objectives. Lengthening osteotomies of the calcaneus in children are in general grafted with bone from the iliac crest. Artificial bone grafts have been introduced, however, their structural and clinical durability has not been documented. Radiostereometric analysis (RSA) is a very accurate and precise method for measurements of rigid body movements including the evaluation of joint implant and fracture stability, however, RSA has not previously been used in clinical studies of calcaneal osteotomies. We assessed the precision of RSA as a measurement tool in a lateral calcaneal lengthening osteotomy (LCLO). Methods. LCLO was performed in six fixed adult cadaver feet. Tantalum markers were inserted on each side of the osteotomy and in the cuboideum. Lengthening was done with a plexiglas wedge. A total of 24 radiological double examinations were obtained. Two feet were excluded due to loose and poorly dispersed markers. Precision was assessed as systematic bias and 95% repeatability limits. Results. Systematic bias was generally below 0.10 mm for translations. Precision of migration measurements was below 0.2 mm for translations in the osteotomy. Conclusion. RSA is a precise tool for the evaluation of stability in LCLO. Cite this article: Bone Joint Res 2015;4:78–83


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_7 | Pages 27 - 27
1 Jul 2020
Hurry J Spurway A Dunbar MJ El-Hawary R
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Radiostereometric analysis (RSA) allows for precise measurement of interbody distances on X-ray images, such as movement between a joint replacement implant and the bone. The low radiation biplanar EOS imager (EOS imaging, France) scans patients in a weight-bearing position, provides calibrated three-dimensional information on bony anatomy, and could limit the radiation during serial RSA studies. Following the ISO-16087 standard, 15 double exams were conducted to determine the RSA precision of total knee arthroplasty (TKA) patients in the EOS imager, compared to the standard instantaneous, cone-beam, uniplanar digital X-ray set-up. At a mean of 5 years post-surgery, 15 TKA participants (mean 67 years, 12 female, 3 male) were imaged twice in the biplanar imager. To reduce motion during the scan, a support for the foot was added and the scan speed was increased. The voltage was also increased compared to standard settings for better marker visibility over the implant. A small calibration object was included to remove any remaining sway in post-processing. The 95% confidence interval precision was 0.11, 0.04, and 0.15 mm in the x, y, and z planes, respectively and 0.15, 0.20, and 0.14° in Rx, Ry, and Rz. Two participants had motion artifacts successfully removed during post-processing using the small calibration object. With faster speeds and stabilization support, this study found an in vivo RSA precision of ≤ 0.15 mm and ≤ 0.20° for TKA exams, which is within published uniplanar values for arthroplasty RSA. The biplanar imager also adds the benefits of weight bearing imaging, 3D alignment measurements, a lower radiation dose, and does not require a reference object due to known system geometry and automatic image registration


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 239 - 240
1 May 2006
Khan R Fick D Lee M Alakeson R Bowers A Wood D Nivbrant B
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Introduction Primary and revision total hip surgery in the face of poor neuromuscular function, cognitive impairment or recurrent dislocation are fraught with complications. A useful option for such cases is the constrained acetabular component, or “captive cup”. We present the largest series reported to date, and use radiostereometric analysis (RSA) to assess cup migration. Method Between February 1999 and September 2003 133 patients (141 hips) were identified as high risk of dislocation and were treated with a constrained acetabular component. One hundred and twenty cases were revision arthroplasties and 21 were primary replacements. Patients were assessed pre-operatively (WOMAC, Harris Hip Scores and SF-36). Defects were reconstructed with allograft (massive, morsellised or strut) where required. Most components were inserted into uncemented metal cups. Radiostereometric beads were inserted. Post-operatively patients were followed up regularly and clinical scores repeated. Radiostereometric analysis (RSA) was performed at 6 months, and then annually to assess prosthesis migration. Results Mean follow-up was 3.1 years (range 1 – 5.6 years). At last review 26 patients had died, and 7 were lost to follow-up. There were 8 revisions for cup loosening. There were 5 dislocations and 2 dissociations in 6 patients. There was a statistically significant improvement in WOMAC and Harris Hip scores. RSA confirmed cup migration was greater than for non-captive cups, but was nevertheless minimal. Interestingly there was no statistically significant difference at 6, 12 and 24 months suggesting most migration occurs early on. Conclusion Our results suggest the “captive cup” is an effective and safe option for the treatment of primary and revision arthroplasty in those at high risk of dislocation


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_4 | Pages 4 - 4
1 Mar 2021
Bragonzoni L Cardinale U Bontempi M Di Paolo S Zinno R Alesi D Muccioli G Pizza N Di Sarsina T Agostinone P Zaffagnini S
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Physiological kinematics is very difficult to restore after total knee arthroplasty (TKA). A new model of medial stabilized (MS) TKA prosthesis has a high spherical congruence of the internal compartment, which guarantees anteroposterior (AP) stability associated with a flat surface of the insert in the lateral compartment, that allows a greater AP translation of the external condyle during knee flexion. The aim of our study is to evaluate, by dynamic radiostereometric analysis (RSA), the knee in vivo kinematics after the implantation of a MS prosthesis during sit to stand and lunge movements. To describe the in vivo kinematics of the knee after MS Fixed Bearing TKA (GMK Sphere (TM) Medacta International AG, Castel San Pietro, Switzerland) using Model Based dynamic RSA. A cohort of 18 patients (72.1 ± 7.4 years old) was evaluated by dynamic RSA 9 months after TKA. The kinematic evaluation was carried out using the dynamic RSA tool (BI-STAND DRX 2), developed at our Institute, during the execution of sit to stand and lunge movements. The kinematic data were processed using the Grood and Suntay decomposition and the Low Point method. The patients performed two motor tasks: a sit-to-stand and a lunge. Data were related to the flexion angle versus internal-external, varus-valgus rotations and antero-posterior translations of the femur with respect to the tibia. During the sit to stand, the kinematic analysis showed the presence of a medial pivot, with a significantly greater (p=0.0216) anterior translation of the lateral condyle (3.9 ± 0.8 mm) than the medial one (1.6 ± 0.8 mm) associated with a femoral internal rotation (4.5 ± 0.9 deg). During the lunge, in the flexion phase, the lateral condyle showed a larger posterior translation than the medial one (6.2 ± 0.8 mm vs 5.3 ± 0.8 mm) associated with a femoral external rotation (3.1 ± 0.9 deg). In the extension phase, there is a larger anterior translation of the lateral condyle than the medial one (5.8 ± 0.8 mm vs 4.6 ± 0.8 mm) associated with femoral internal rotation (6.2 ± 0.9 deg). Analysing individual kinematics, we also found a negative correlation between clinical scores and VV laxity during sit to stand (R= −0.61) and that the higher femoral extra-rotation, the poorer clinical scores (R= 0.65). The finding of outliers in the VV and IE rotations analysis highlights the importance of a correct soft tissue balancing in order to allow the prosthetic design to manifest its innovative features


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_9 | Pages 72 - 72
1 Oct 2020
Howard JL Williams HA Lanting BA Teeter MG
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Background. In recent years, the use of modern cementless implants in total knee arthroplasty has been increasing in popularity. These implants take advantage of new technologies such as additive manufacturing and potentially provide a promising alternative to cemented implant designs. The purpose of this study was to compare implant migration and tibiofemoral contact kinematics of a cementless primary total knee arthroplasty (TKA) implanted using either a gap balancing (GB) or measured resection (MR) surgical technique. Methods. Thirty-nine patients undergoing unilateral TKA were recruited and assigned based on surgeon referral to an arthroplasty surgeon who utilizes either a GB (n = 19) or a MR (n = 20) surgical technique. All patients received an identical fixed-bearing, cruciate-retaining beaded peri-apatite coated cementless femoral component and a pegged highly porous cementless tibial baseplate with a condylar stabilizing tibial insert. Patients underwent a baseline radiostereometric analysis (RSA) exam at two weeks post-operation, with follow-up visits at six weeks, three months, six months, and one year post-operation. Migration including maximum total point motion (MTPM) of the femoral and tibial components was calculated over time. At the one year visit patients also underwent a kinematic exam using the RSA system. Results. Mean MTPM of the tibial component at one year post-operation was not different (mean difference = 0.09 mm, p = 0.980) between the GB group (0.85 ± 0.37 mm) and the MR group (0.94 ± 0.41 mm). Femoral component MTPM at one year post-operation was also not different (mean difference = 0.27 mm, p = 0.463) between the GB group (0.62 ± 0.34 mm) and the MR group (0.89 ± 0.44 mm). Both groups displayed a lateral pivot pattern with similar frequencies of condylar separation. Conclusion. There was no difference in implant migration and kinematics of a single-radius, cruciate retaining cementless TKA performed using a GB or MR surgical technique. The magnitude of migration suggests there is no risk of early loosening. The results provide support for the use of a cementless TKA as a viable alternative to cemented fixation


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 10 | Pages 1344 - 1350
1 Oct 2012
Penny JO Ding M Varmarken JE Ovesen O Overgaard S

Radiostereometric analysis (RSA) can detect early micromovement in unstable implant designs which are likely subsequently to have a high failure rate. In 2010, the Articular Surface Replacement (ASR) was withdrawn because of a high failure rate. In 19 ASR femoral components, the mean micromovement over the first two years after implantation was 0.107 mm (. sd. 0.513) laterally, 0.055 mm (. sd. 0.204) distally and 0.150 mm (. sd. 0.413) anteriorly. The mean backward tilt around the x-axis was -0.08° (. sd. 1.088), mean internal rotation was 0.165° (. sd. 0.924) and mean varus tilt 0.238° (. sd. 0.420). The baseline to two-year varus tilt was statistically significant from zero movement, but there was no significant movement from one year onwards. We conclude that the ASR femoral component achieves initial stability and that early migration is not the mode of failure for this resurfacing arthroplasty


The Bone & Joint Journal
Vol. 95-B, Issue 5 | Pages 605 - 608
1 May 2013
Murray DW Gulati A Gill HS

The Exeter femoral stem is a double-tapered highly polished collarless cemented implant with good long-term clinical results. In order to determine why the stem functions well we have undertaken a long-term radiostereometric analysis (RSA) study. A total of 20 patients undergoing primary Exeter total hip replacement for osteoarthritis using the Hardinge approach were recruited and followed with RSA for ten years. The stems progressively subsided and internally rotated with posterior head migration. The mean subsidence was 0.7 mm (95% confidence interval (CI) 0.5 to 0.9) at two years and 1.3 mm (95% CI 1.0 to 1.6) at ten years. The mean posterior migration of the head was 0.7 mm (95% CI 0.5 to 0.9) at two years and 1.2 mm (95% CI 1.0 to 1.4) at ten years. There was no significant cement restrictor migration. The Exeter stem continues to subside slowly into the cement mantle in the long term. This appears to compress the cement and the cement bone interface, contributing to secure fixation in the long term. Cite this article: Bone Joint J 2013;95-B:605–8


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 67 - 67
1 Mar 2006
Khan R Fick D Lee M Alakeson R De Cruz M Wood D Nivbrant B
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Introduction: Primary and revision total hip surgery in the face of poor neuromuscular function, cognitive impairment or recurrent dislocation are fraught with complications. A useful option for such cases is the constrained acetabular component, or “captive cup”. We present the largest series reported to date, and use radiostereometric analysis (RSA) to assess cup migration. Method: Between February 1999 and September 2003 126 patients were identified as high risk of dislocation and were treated with a constrained acetabular component. One hundred and sixteen cases were revision arthroplasties and 10 were primary replacements. Patients were assessed pre-operatively (WOMAC, Harris Hip Scores and SF-36). Defects were reconstructed with allograft (massive, morsellised or strut) where required. All components were inserted into uncemented metal cups. Radiostereometric beads were inserted. Post-operatively patients were followed up regularly and clinical scores repeated. Radiostereometric analysis (RSA) was performed at 6 months, and then annually to assess prosthesis migration. Results: Mean follow-up was 3.1 years (range 1 – 5.6 years). At last review 8 patients had died, and 2 were lost to follow-up. There were 7 revisions: 3 for infection, 2 for periprosthetic fractures, and 2 for aseptic loosening. There was one case of cup disassociation successfully treated with open reduction. There have been no further dislocations. There was a statistically significant improvement in WOMAC and Harris Hip scores. RSA confirmed cup migration was greater than for non-captive cups, but was nevertheless acceptable: 0.16mm medially, 0.47mm proximally, 0.16mm posteriorly. Interestingly there was no statistically significant difference at 6, 12 and 24 months suggesting most migration occurs early on. Conclusion: Our results suggest the “captive cup” is an effective and safe option for the treatment of primary and revision arthroplasty in those at high risk of dislocation. RSA analysis confirms minimal prosthesis migration


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 139 - 139
1 Jul 2014
Ayers D Snyder B Porter A Walcott M Aubin M Drew J Greene M Bragdon C
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Summary Statement. In young, active patients cementless THR demonstrates excellent prosthetic stability by RSA and outstanding clinical outcomes at 5 years using a tapered titanium femoral stem, crosslinked polyethylene liners and either titanium or tantalum shells. Introduction. Early femoral implant stability is essential to long-term success in total hip replacement. Radiostereometric analysis (RSA) provides precise measurements of micromotion of the stem relative to the femur that are otherwise not detectable by routine radiographs. This study characterised micromotion of a tapered, cementless femoral stem and tantalum porous-coated vs. titanium acetabular shells in combination with highly cross-linked UHMWPE or conventional polyethylene liners using radiostereometric analysis (RSA) for 5 years following THR. Patients and Methods. This IRB-approved, prospective, double randomised, blinded study, involved 46 patients receiving a primary THR by a single surgeon. Each patient was randomised to receive a titanium (23) (Trilogy, Zimmer) or tantalum (23) (Modular Tantalum shell, Zimmer) uncemented hemispheric shell and either a highly-crosslinked or conventional polyethylene liner. Tantalum RSA markers were implanted in each patient. All patients had a Dorr A or B femoral canal and received a cementless, porous-coated titanium tapered stem (M/L Taper, Zimmer). All final femoral broaches were stable to rotational and longitudinal stress. RSA examinations, Harris Hip, UCLA, WOMAC, SF-12 scores were obtained at 10 days, 6 months, and annually through 5 years. Results. All patients demonstrated statistically significant improvement in Harris Hip, WOMAC, and SF-12 PCS scores post-operatively. Evaluation of polyethylene wear demonstrated that median penetration measurements were significantly greater in the conventional compared to the HXPLE liner cohorts at 1 year through 5 years follow-up (p<0.003). At 5 years, conventional liners showed 0.38 ± 0.05mm vertical wear whereas HXLPE liners showed 0.08 ± 0.02mm (p<0.003). Evaluation of the femoral stems demonstrated that the rate of subsidence was highest in the first 6 months (0.09mm/yr), with no other detectable motion through 5 years. Two outlying patients had significantly higher stem subsidence values at 6 months (0.7 mm and 1.0mm). One stem stabilised without further subsidence after 6 months (0.7mm), and the other stem stabilised at 1 year (1.5mm). Neither patient has clinical evidence of loosening. Evaluation of acetabular shells demonstrated less median vertical translation in tantalum than titanium shells at each time-point except at 3-years follow-up, however due to large standard errors, there was no significant difference between the two designs (p>0.05). These large standard errors were predominantly caused by two outliers, neither of which had clinical evidence of loosening. Discussion/Conclusion. In this RSA study of young THR patients, cementless tapered femoral stems, highly crosslinked polyethylene liners, and tantalum or titanium acetabular shells all demonstrated excellent performance through 5 years follow-up. Highly crosslinked polyethylene liners demonstrated significantly less wear than conventional liners. The femoral stem showed excellent stability through 5 years, with no clinical or radiologic episodes of failure. The small amount of micromotion seen is less than that previously reported for similar tapered, cementless stems and approaches the accuracy of RSA (0.05mm). Both acetabular shells demonstrated excellent stability with minimal micromotion at 5 years without significant differences in migration. All patients demonstrated significant clinical improvement in pain and function and additional RSA evaluation of these patients is planned


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 90 - 90
1 Feb 2020
Gascoyne T Parashin S Zarrabian M
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Introduction. This research determines the feasibility of radiostereometric analysis (RSA) as a diagnostic tool for assessing fusion following spinal arthrodesis. Further, to estimate clinical thresholds for precision and accuracy of the proposed method in the cervical and lumbar spine. Methods. Two-level lumbo-sacral and three-level cervical posterior arthrodesis procedures were performed on an artificial spine model and a cadaveric spine (Figure 1). Using a spring-loaded inserter, RSA marker beads were placed within each of the L4-S1 and C3-C6 vertebrae, then analyzed for optimal bead distribution and detection. RSA imaging consisted of 12 double exams (24 exams) of the cervical and lumbar regions for both the Sawbones and cadaveric spine to assess precision of measurement under zero-displacement conditions, defined as the 95% confidence interval of error. Accuracy assessment was performed on the Sawbones model in which the middle vertebrae (L5 and C4-C5) were moved relative to the superior (L4 and C3) and inferior (S1 and C6) vertebrae by known, incremental displacements (Figure 2). RSA images were obtained at each displacement (Figure 3). Accuracy was defined as the mean difference between known and measured displacements. Results. Median RSA bead detection was 100% in cervical vertebrae and >75% in lumbar vertebrae in the artificial and cadaveric models. Translational RSA precision for both spine models was better than 0.25mm and 0.82mm for the lumbar and cervical regions, respectively. Rotational precision was better than 0.4° and 1.9° for the lumbar and cervical regions, respectively. RSA accuracy for the artificial spine overall demonstrated less than 0.11 mm translational bias (margin < ±0.02 mm) and less than 0.22° rotational bias (margin < ±0.15°). Discussion and Conclusion. This study demonstrates that RSA achieves sufficient precision and accuracy to detect intervertebral micromotion for the purpose of assessing arthrodesis. Well dispersed bead placement is critical to achieving sufficient accuracy and avoiding occlusion by metal hardware. The results of this work will aid in the development of a clinical study to assess arthrodesis in patients. For any figures or tables, please contact the authors directly


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 6 | Pages 730 - 735
1 Jun 2007
Derbyshire B Porter ML

We performed a three-year radiostereometric analysis (RSA) study of the Elite Plus femoral component on 25 patients undergoing primary total hip replacement. Additional assessments and measurements from standard radiographs were also made. Subsidence of the stem occurred at the cement-stem interface. At 36 months the subsidence of the stem centroid was a mean of 0.30 mm (0.02 to 1.28), and was continuing at a slow rate. At the same time point, internal rotation and posterior migration of the femoral head had ceased. One stem migrated excessively and additional assessments suggested that this was probably due to high patient demand. The failure rate of 4% in our study is consistent with data from arthroplasty registers but contrasts with poor results from another RSA study, and from some clinical studies. We believe that the surgical technique, particularly the use of high-viscosity cement, may have been an important factor contributing to our results


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 43 - 43
1 Aug 2020
Laende E Dunbar MJ Richardson G
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The dual mobility design concept for acetabular components is intended to reduce the risk of dislocation and increase range of motion, but the wear pattern of this design is unclear and may have implications in implant fixation. Additionally, the solid back cups do not have the option for supplementary screw fixation, providing an additional smooth articulating surface for the liner to move against. The objective of this study was to assess cup fixation by measuring implant migration as well as proximal femoral head penetration to evaluate wear performance. Thirty subjects were recruited in a consecutive series prospective study and received dual mobility uncemented acetabular components with mobile bearing polyethylene liners through a direct lateral approach. Femoral stems were cemented or uncemented. All subjects had 28 mm femoral heads. The femur, acetabulum, and non-articulating surface of the mobile polyethylene liner were marked with tantalum beads. Radiostereometric analysis (RSA) exams were performed post-operatively and at 6 weeks, 3 months, 6 months, 1 year, 2 years, and 3 years. Oxford 12 Hip and Satisfaction questionnaire responses were recorded. Mobile bearing motion was assessed under fluoroscopy for a single case under loaded and unloaded conditions. Twenty-nine subjects (17 female) proceeded to surgery. Subjects were 63±11 years of age with BMIs of 28±4.7 kg/m2. Cup migration reached 0.16 ± 0.31 mm of proximal translation and 0.29±1.03 degrees of sagittal rotation at three years. A single individual had more than 3 degrees of cup rotation, occurring by 6 months and not substantially increasing after this time. Proximal translation was low for this subject. Wear of the highly cross-linked mobile bearings was 0.18 ± 0.30 mm of proximal femoral head penetration from 0 to 3 years. The mean wear rate from 1 to 3 years was 0.02 mm/year. One subject was an outlier for wear, with more than 1 mm of femoral head penetration at 1 year. However, wear did not increase after 1 year for this subject and cup migrations were below average for this individual. Similarly, the outlier for cup rotation had below average wear. Satisfaction (out of 100%) improved from 25±27% to 96±7% pre-operatively to 3 years post-operatively. Oxford 12 scores (best possible score of 48) improved from 21±7 to 43±7 over the same period. The fluoroscopic case study demonstrated visible motion of the mobile bearing during hip rotation tasks. The overall migration of the cup was low and demonstrated favorable patterns suggesting low risk of aseptic loosening. Wear rates are also within the expected range of 0 to 0.06 mm/year for highly cross-linked polyethylene. The combination of low subsidence and low sagittal rotations of the cup, and low wear of the polyethylene are favorable predictors of good long-term performance


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 56 - 56
1 Feb 2020
Broberg J Howard J Lanting B Vasarhelyi E Yuan X Naudie D Teeter M
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Introduction. Surgeons performing a total knee replacement (TKR) have two available techniques available to help them achieve the proper bone resections and ligament tension – gap balancing (GB) and measured resection (MR). GB relies on balancing ligaments prior to bony resections whereas bony resections are made based on anatomical landmarks in MR. Many studies have been done to compare the joint kinematics between the two techniques, however the results have been varied. These studies were not done with anatomically designed prostheses. The Journey II (Smith & Nephew, Memphis, TN) is one such design which attempts to mimic the normal knee joint structure to return more natural kinematics to the joint, with emphasis on eliminating both paradoxical anterior motion and reduced posterior femoral rollback. Given the design differences between anatomical and non-anatomical prostheses, it is important to investigate whether one technique provides superior kinematics when an anatomical design is used. We hypothesize that there will be no difference between the two techniques. Methods. A total of 56 individuals were recruited to receive a Journey II prosthesis and randomized evenly to groups where the GB technique or MR technique is used. For all patients in the study, a series of radiostereometric analysis (RSA) images were acquired at 3-months post-operatively at different knee flexion angles, ranging in 20° increments from 0° to 120°. Model-based RSA software (RSACore, Leiden, Netherlands) was used to obtain the 3D positions and orientations of the femoral and tibial implant components, which were in turn used to obtain kinematic measures (contact locations and magnitude of excursion) for each condyle. Results. Preliminary results for the anterior-posterior (AP) contact locations from 33 patients (18 GB, 15 MR) are displayed in Figure 1. There were no significant differences in medial and lateral contact locations between the GB and MR groups for all angles of flexion. However, the pattern of medial contact for the MR technique displays more paradoxical anterior motion at mid-flexion (40°–60°) than the GB group. There were no significant differences in magnitude of excursion between groups on both medial (mean difference=1.96 mm, p=0.16) and lateral (mean difference=0.21 mm, p=0.79) condyles, indicating that posterior femoral rollback is similar between groups. Conclusions. Early results suggest that the MR technique is associated with slightly more abnormal kinematics than the GB technique when an anatomical prosthesis design is used for TKR. The GB technique may be more appropriate than MR technique for implanting anatomically designed knee replacements. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 2 - 2
1 Feb 2020
Turgeon T Burnell C Hedden D Gascoyne T Bohm E
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Introduction. Total hip arthroplasty (THA) is a highly successful procedure achieving excellent clinical outcomes beyond 10 years post-surgery. With exception of periprosthetic infection, dislocation is the most common cause of failure in THA. A novel reverse total hip (RTH) replacement has been developed to address dislocation through reversal of the typical THA articulation in which a femoral cup and acetabular ball interlock at the extremes of motion to enhance mechanical stability in all planes. The purpose of this study was to assess the safety and efficacy of this novel RTH in a series of 22 patients and to monitor implant fixation using radiostereometric analysis (RSA). Methods. Twenty two patients with end-stage osteoarthritis of the hip were enrolled between 2017 and 2019 at a single center. All surgeries were performed by a group of four high-volume fellowship-trained arthroplasty surgeons. All patients received at least 1 acetabular cup screw and RSA markers inserted into the acetabulum and proximal femur. Follow-up time points were 6 weeks, 6, 12 and 24 months and included patient reported outcome measures (HOOS, Oxford-12, Harris Hip Score, SF-36 and Satisfaction) as well as RSA assessment. Results. The patient cohort consisted of 11 females and 11 males with mean age of 70.8 years and body mass index 31.3 kg/m. 2. At the time of writing, 21, 15 and 3 patients had completed their 6-month, 1- and 2-year clinical follow-ups, respectively. There was a significant improvement in function and pain with the RTH between pre-operative and six and twelve month follow up as collected by the HOOS, Oxfrod-12, HHS, WOMAC, EQ-5D and SF-36 PCS with p<0.001 for all. The sole exception was the SF-36 MCS which had a non-statistical improvement. Eighteen of 20 patients were satisfied or very satisfied with the outcome of surgery. Average vertical migration of the acetabular cup at 6 and 12 months was 0.082 mm and 0.110 mm, respectively. Average distal migration of the femoral stem at 6 and 12 months was 0.015 mm and 0.035 mm, respectively. Conclusions. Early results indicate acceptable safety and efficacy of this novel RTH for treating osteoarthritis of the hip. The femoral and acetabular components both appear well fixed at near-term follow-up, as assessed with RSA. Further follow-up will determine if these results are maintained at 24 months post-surgery. Additional patient enrollment will assess acetabular cup fixation without the use of screws. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 55 - 55
1 Feb 2020
Broberg J Howard J Lanting B Vasarhelyi E Yuan X McCalden R Naudie D Teeter M
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Introduction. Despite improvements in the survivorship of total knee replacements (TKR) over the years, patient satisfaction following TKR has not improved, with approximately 20% of patients recording dissatisfaction with their new knee joint. It is unclear why many patients feel this way, but it may relate in part to implant designs that do not provide a “natural” feeling knee. Implant manufacturers continue to introduce new concepts for implant design, which are essential for reaching the goal of a “normal” knee after TKR surgery. The Journey II TKR (Smith & Nephew) was developed with this goal in mind. Its anatomical design attempts to mimic the normal knee joint structure to return more natural kinematics to the joint, with emphasis on eliminating both paradoxical anterior motion and reduced posterior femoral rollback. Our objective is to examine patients receiving the Journey II TKR to measure the knee joint contact kinematics of the Journey II TKR compared to a non-anatomically designed implant by the same manufacturer. We hypothesize that the Journey II TKR will have more natural contact kinematics that differ from the non-anatomically designed implant. Methods. A total of 28 individuals were recruited to receive a Journey II TKR, matching an existing prior cohort with a non-anatomical design from the same manufacturer (Legion TKR, Smith & Nephew). For both groups, a series of radiostereometric analysis (RSA) images were acquired at different knee flexion angles, ranging in 20° increments from 0° to 120°. Model-based RSA software (RSACore, Leiden, Netherlands) was used to obtain the 3D positions and orientations of the femoral and tibial implant components, which were in turn used to obtain kinematic measures (contact locations and magnitude of excursion) for each condyle. Results from the Journey II TKR group at 3 months post-operation were compared to the 2-year post-operative measurements from the Legion TKR group. Results. Preliminary results for the anterior-posterior (AP) contact locations from 38 patients (15 Journey II TKR, 23 Legion TKR) are displayed in Figure 1. The Journey II TKR group showed more anterior contact medially and laterally relative to the Legion TKR group at many angles, however the overall pattern from 0°–120° was similar. There was no significant difference between groups with respect to magnitude of excursion on both medial (mean difference=1.29 mm, p=0.19) and lateral (mean difference=0.69 mm, p=0.60) condyles. Conclusions. Early results suggest that paradoxical anterior motion and reduced posterior femoral rollback are present in the anatomically designed Journey II TKR, suggesting that it does not provide substantially different knee kinematics compared to the non-anatomically designed Legion TKR. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 22 - 22
1 Feb 2020
Van De Kleut M Athwal G Yuan X Teeter M
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Introduction. Reverse total shoulder arthroplasty (RTSA) is rapidly being adopted as the standard procedure for a growing number of shoulder arthropathies. Though short-term outcomes are promising, mid- and long-term follow-ups present a number of complications – among them, humeral stem and glenosphere component loosening. Though not the primary complication, previously reported aseptic loosening required revision in 100% of cases. As the number of patients undergoing RTSA increases, especially in the younger population, it is important for surgeons to identify and utilize prostheses with stable long-term fixation. It has previously been shown in the hip and knee literature that implant migration in the first two years following surgery is predictive of later failure due to loosening in the 5=10-year postoperative window. The purpose of this study is to, for the first time, evaluate the pattern and total magnitude of implant migration in reverse shoulder arthroplasty using the gold standard imaging technique radiostereometric analysis (RSA). Methods. Forty patients were prospectively randomized to receive either a cemented or press-fit humeral stem, and a glenosphere secured to the glenoid with either autologous bone graft or 3D printed porous titanium for primary reverse total shoulder arthroplasty. Following surgery, participants are imaged using RSA, a calibrated, stereo x-ray technique. Radiographs are acquired at 6 weeks (baseline), 3 months, 6 months, 1 year, and 2 years. Migration of the humeral stem and glenosphere at each time point is compared to baseline. Migration of the prostheses is independently compared between humeral stem fixation groups and glenosphere fixation groups using a two-way repeated measures ANOVA with Tukey's test for multiple comparisons. Results. Follow-ups are ongoing and preliminary results are presented. Significant differences were observed at the 6-month and 1-year time points for superior-inferior translation (p = 0.0067, p = 0.0048), and total three-dimensional translation (p = 0.0011, p = 0.0272) between humeral stems, with press-fit humeral stems subsiding significantly more than cemented stems. Migration between the 6-month and 1-year time points was minimal for both stem fixation groups (less than 0.2 mm). No significant differences were observed along any axis at any time point for the glenosphere fixation groups. Conclusion. There is a trend towards increased subsidence with the use of press-fit stems compared to cemented stems in the first six months postoperatively, as is expected. Both implant fixation techniques demonstrate stability from six months through one year, and this trend is expected through two-year follow-up. Similarly, both glenosphere fixation techniques demonstrate immediate and stable fixation through one year


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 50 - 50
1 Jul 2020
Gascoyne T Parashin S Zarrabian M
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The purpose of this research was to determine the feasibility of radiostereometric analysis (RSA) as a diagnostic tool for assessing non-union following spinal arthrodesis procedures. Further, to estimate clinical thresholds for precision and accuracy of the proposed method in the cervical and lumbar spine. A three-level lumbo-sacral and a four-level cervical posterior arthrodesis procedures were performed on an artificial spine model (Sawbones, WA). Using a spring loaded inserter (RSA Biomedical, Sweden), eight to ten RSA markers were placed within each of the L4 and L5 segments in the spinous process (L4 only), lamina, transverse processes, posterior and anterior (down the pedicle) wall of the vertebral body. Eight to ten markers were placed within the proximal sacrum (S1) at the medial and lateral crests, tuberosity, and within the sacral canal wall. Four to eight RSA markers were placed into the C3-C6 lateral masses. Titanium screws and rods were applied to the spinal segments. Identical procedures were then performed on a cadaveric spine using similar bead placement and hardware. RSA imaging consisted of 12 double exams (24 exams) of the cervical and lumbar regions for both the Sawbones and cadaveric spine to assess precision of measurement under zero-displacement conditions. The most distal vertebrae were considered the datum against which the movement of all other vertebrae was compared. The artificial spine was then dismantled for accuracy assessment in which the middle vertebrae (L5 and C4-C5) were moved relative to the superior (L4 and C3) and inferior (S1 and C6) vertebrae by known, incremental displacements on an imaging phantom device. Displacements occurred along the superior-inferior, anterior-posterior, and flexion-extension (rotational) axes of motion. RSA images were obtained at each displacement. Image analysis was performed using model-based software (RSACore v3.41, Leiden, Netherlands) to visualize implanted RSA beads in 3-D space. Precision was defined as the 95% confidence interval of error in measuring zero-displacement. Accuracy was defined as the mean difference (with 95% confidence interval) between the known and measured displacement. The rate of RSA bead detection was high with 5–8 implanted beads being visible in both the lumbar and cervical regions of the artificial and cadaveric spines. Translational RSA precision for both spines was better than 0.25 mm and 0.82 mm for the lumbar and cervical regions, respectively. Rotational precision was better than 0.40° and 1.9° for the lumbar and cervical regions, respectively. RSA accuracy for the artificial spine overall demonstrated less than 0.11 mm translational bias (margin < ±0.02 mm) and less than 0.22° rotational bias (margin < ±0.15°). This study demonstrates that RSA achieves sufficient precision and accuracy to detect intervertebral micromotion for the purpose of assessing arthrodesis. Well dispersed RSA bead placement is critical to achieving sufficient accuracy as well as avoiding occlusion by metal hardware. Cervical bead implantation is particularly sensitive to bead clustering due to small vertebrae size and proximity to critical structures. The results of this work will aid in the development of a clinical study to assess arthrodesis in patients


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 8 - 8
1 Apr 2019
Wilson C Critchely O Callary S Campbell D
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Introduction & aims. The magnitude and pattern of acceptable migration in clinically successful cementless stems is not well understood. Radiostereometric analysis (RSA) is a well-recognised method of assessing implant migration. Previous studies have reported long term RSA results for cemented stems. The aim of this study was to assess the long-term migration characteristics of the Corail hydroxyapatite-coated cementless stem at 10 years using RSA. Method. A prospective cohort of 30 patients undergoing primary total hip arthroplasty for primary hip osteoarthritis were enrolled into a study to characterise the migration behaviour of a cementless stem. Tantalum markers were attached to the stem and placed in the bone intraoperatively, allowing for RSA measurements to be taken in vivo. Previous 5-year results have been presented. A total of 14 patients (total 15 hips, one bilateral) with mean age 82 years (range, 69–92 years) underwent repeat long-term RSA radiographs at minimum 10 years post op. The mean time to follow up was 13.9 years (range, 13.3–14.4 years). The RSA radiographs were analysed to assess for implant rotation and translation. Results. None of the 14 patients (15 hips) followed up have been revised. The migration (rotation and translation) at 6 months, 1 year, 2 years, and 6 years has been described previously. No stems had additional subsidence of more than 0.25 mm between 6 months and 6 years. The resultant mean subsidence between 2 years and 6 years was 0.03 mm, which is below the limit measurable by RSA. The long-term, 10-year results, on implant rotation and translation will be presented. Conclusions. The Corail stem exhibited variable subsidence within the first 6 months after which there is persistent stabilisation through to 6 years. 10-year results on long-term migration show no further migration. These results can be used as a gold standard for other uncemented stems


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 32 - 32
1 Jul 2020
Perelgut M Teeter M Lanting B Vasarhelyi E
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Increasing pressure to use rapid recovery care pathways when treating patients undergoing total hip arthroplasty (THA) is evident in current health care systems for numerous reasons. Patient autonomy and health care economics has challenged the ability of THA implants to maintain functional integrity before achieving bony union. Although collared stems have been shown to provide improved axial stability, it is unclear if this stability correlates with activity levels or results in improved early function to patients compared to collarless stems. This study aims to examine the role of implant design on patient activity and implant fixation. The early follow-up period was examined as the majority of variation between implants is expected during this time-frame. Patients (n=100) with unilateral hip OA who were undergoing primary THA surgery were recruited pre-operatively to participate in this prospective randomized controlled trial. All patients were randomized to receive either a collared (n=50) or collarless (n=50) cementless femoral stem. Patients will be seen at nine appointments (pre-operative, < 2 4 hours post-operation, two-, four-, six-weeks, three-, six-months, one-, and two-years). Patients completed an instrumented timed up-and-go (TUG) test using wearable sensors at each visit, excluding the day of their surgery. Participants logged their steps using Fitbit activity trackers and a seven-day average prior to each visit was recorded. Patients also underwent supine radiostereometric analysis (RSA) imaging < 2 4 hours post-operation prior to leaving the hospital, and at all follow-up appointments. Nineteen collared stem patients and 20 collarless stem patients have been assessed. There were no demographic differences between groups. From < 2 4 hours to two weeks the collared implant subsided 0.90 ± 1.20 mm and the collarless implant subsided 3.32 ± 3.10 mm (p=0.014). From two weeks to three months the collared implant subsided 0.65 ± 1.54 mm and the collarless implant subsided 0.45 ± 0.52 mm (p=0.673). Subsidence following two weeks was lower than prior to two weeks in the collarless group (p=0.02) but not different in the collared group. Step count was reduced at two weeks compared to pre-operatively by 4078 ± 2959 steps for collared patients and 4282 ± 3187 steps for collarless patients (p=0.872). Step count increased from two weeks to three months by 6652 ± 4822 steps for collared patients and 4557 ± 2636 steps for collarless patients (p=0.289). TUG test time was increased at two weeks compared to pre-operatively by 4.71 ± 5.13 s for collared patients and 6.54 ± 10.18 s for collarless patients (p=0.551). TUG test time decreased from two weeks to three months by 7.21 ± 5.56 s for collared patients and 8.38 ± 7.20 s for collarless patients (p=0.685). There was no correlation between subsidence and step count or TUG test time. Collared implants subsided less in the first two weeks compared to collarless implants but subsequent subsidence after two weeks was not significantly different. The presence of a collar on the stem did not affect patient activity and function and these factors were not correlated to subsidence, suggesting that initial fixation is instead primarily related to implant design


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 56 - 56
1 Feb 2020
Perelgut M Lanting B Teeter M
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Background. There is increasing impetus to use rapid recovery care pathways when treating patients undergoing total hip arthroplasty (THA). The direct anterior (DA) approach is a muscle sparing technique that is believed to support these new pathways. Implants designed for these approaches are available in both collared and collarless variations and understanding the impact each has is important for providing the best treatment to patients. Purpose/Aim of Study. This study aims to examine the role of implant design on implant fixation and patient recovery. Materials and Methods. Patients (n=50) with unilateral hip OA who were undergoing primary DA THA surgery were recruited pre-operatively to participate in this prospective randomized controlled trial. All patients were randomized to receive either a collared (n=25) or collarless (n=25) cementless, fully hydroxyapatite coated femoral stem. Patients were seen at nine appointments (pre-operative, <24 hours post-operation, two-, four-, six-weeks, three-, six-months, one-, and two-years). Patients underwent supine radiostereometric analysis (RSA) imaging <24 hours post-operation prior to leaving the hospital, and at all follow-up appointments. Patients also completed an instrumented timed up-and-go (TUG) test using wearable sensors at each visit, excluding the day of their surgery. Participants logged their steps using Fitbit activity trackers and a seven-day average prior to each visit was recorded. Findings/Results. Twenty-two patients that received a collared stem and 27 patients that received a collarless stem have been assessed. There were no demographic differences between groups. From <24 hours to two weeks the collared implants subsided 0.90 ± 1.20 mm and the collarless implants subsided 3.80 ± 3.37 mm (p=0.001). From two weeks to three months the collared implants subsided 0.67 ± 1.61 mm and the collarless implants subsided 0.45 ± 0.46 mm (p=0.377). Step count was reduced at two weeks to 3108 ± 1388 steps for collared patients and 2340 ± 1685 steps for collarless patients (p=0.072). Step count was increased at three months to 8939 ± 3494 steps for collared patients and 6114 ± 2529 steps for collarless patients (p=0.034). TUG test time was increased at two weeks compared to pre-operatively by 3.45 ± 6.01 s for collared patients and 2.29 ± 4.92 s for collarless patients (p=0.754). TUG test time decreased from two weeks to three months by 6.30 ± 6.05 s for collared patients and 5.68 ± 4.68 s for collarless patients (p=0.922). Conclusions. Collared implants subsided less in the first two weeks compared to collarless implants but subsequent subsidence after two weeks was not significantly different. Presence of a collar on the stem impacted patient activity but not function. This suggests that both the implant design as well as the surgical technique may play a role in the patient's early post-operative experience


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 27 - 27
1 Oct 2018
Sporer S MacLean L Burger A
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Introduction. Uncemented highly porous titanium implants have been shown to promote osseointegration, and may result in a durable construct for total knee arthroplasty (TKA). Given the mixed results of uncemented TKA, it is important to evaluate the early stability for this product. The objective of the following study was to use radiostereometric analysis (RSA) to assess early fixation of a highly porous tibial baseplate and metal backed patella. Methods. Twenty-seven patients (mean age 64 years, 30% female) undergoing primary TKA consented to participate in this prospective cohort study. All patients received a highly porous tibial baseplate, a metal backed patella and tantalum RSA bone markers. Implant migration was assessed using model-based RSA at 1.5, 3, 6, 12 and 24 months post-operative. Patient reported outcome measures were captured using the same follow-up schedule, and compared to pre-operative measures. Results. There were no adverse events affecting implant fixation, and no revisions. Patient function significantly improved by 3 months post-operation (p < 0.001). The highest rate of tibia and patellar component migration occurred over the first six post-operative weeks, with minimal migration thereafter. Mean maximum total point motion (MTPM) at 24 months was 0.72 (SD 0.34) mm for the tibia, and 0.44 (SD 0.25) mm for the patella. Three tibia baseplates migrated more than 1 standard deviation greater than the mean at 24 months, and also had continuous migration (> 0.2mm of MTPM) in the second post-operative year. One patellar component showed a rapid rate of migration between 6 and 24 months, whereas all other patellar components appeared to stabilize. Conclusions. Osseointegration appears to occur on the highly porous implant surface of the tibia baseplate and metal backed patella, as evidenced by implant stability. Further follow-up is required to determine if clinical loosening will manifest in the continuously migrating implants


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 14 - 14
1 Apr 2019
Van De Kleut M Athwal G Yuan X Teeter M
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Introduction. Total shoulder arthroplasty is the fastest growing joint replacement in recent years, with projected compound annual growth rates of 10% for 2016 through 2021 – higher than those of both the hip and knee combined. Reverse total shoulder arthroplasty (RTSA) has gained particular interest as a solution for patients with irreparable massive rotator cuff tears and failed conventional shoulder replacement, for whom no satisfactory intervention previously existed. As the number of indications for RTSA continues to grow, so do implant designs, configurations, and fixation techniques. It has previously been shown that continuous implant migration within the first two years postoperatively is predictive of later loosening and failure in the hip and knee, with aseptic loosening of implant components a guaranteed cause for revision in the reverse shoulder. By identifying implants with a tendency to migrate, they can be eliminated from clinical practice prior to widespread use. The purpose of this study is to, for the first time, evaluate the pattern and magnitude of implant component migration in RTSA using the gold standard imaging technique radiostereometric analysis (RSA). Methods. Forty patients were prospectively randomized to receive either a cemented or press-fit humeral stem, and a glenosphere secured to the glenoid with either autologous bone graft or 3D printed porous titanium (Aequalis Ascend Flex, Wright Medical Group, Memphis, TN, USA) for primary reverse total shoulder arthroplasty. Following surgery, partients are imaged using RSA, a calibrated, stereo x-ray technique, at 6 weeks (baseline), 3 months, 6 months, 1 year, and 2 years. Migration of the humeral stem and glenosphere at each time point is compared to baseline. Preliminary results are presented, with 15 patients having reached the 6-month time point by presentation. Results. Implant migration of ten participants at the 3-month time point is presented. Maximum total point motion (MTPM) is a measure of translation and rotation of the point on the implant that has moved the most from baseline. Average MTPM ± SD of the humeral stem is 1.18 ± 0.65 mm and 0.98 ± 0.46 mm for press-fit (n = 6) and cemented (n = 4) stems, respectively; and 0.25 ± 0.09 mm and 0.47 ± 0.24 mm for bone graft (n = 4) and porous titanium (n = 6) glenosphere fixations, respectively, at the 3-month time point. Conclusion. There is a trend towards increased migration with the use of press-fit humeral stems and porous titanium glenosphere fixation, though no conclusions can be made from the current sample size. Further, though differences in migration magnitude may be observed at early postoperative time points, it is expected that all fixation techniques will show stability from 1 to 2 years postoperatively


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 109 - 109
1 Jan 2017
van Hamersveld K Valstar E Toksvig-Larsen S
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Whether it is best to retain the posterior cruciate ligament in the degenerated knee, i.e. using a cruciate-retaining (CR) total knee prosthesis (TKP), or to use a more constraint posterior-stabilized (PS) TKP is of debate. There are limited studies comparing the effect of both methods on implant fixation and clinical outcome, leaving it up to the surgeon to base this decision on anything but conclusive evidence. We assessed the effect of two different philosophies in knee arthroplasty on clinical outcome and tibial component migration measured with radiostereometric analysis (RSA), by directly comparing the CR and PS version of an otherwise similarly designed cemented TKP. Sixty patients were randomized and received a Triathlon TKP (Stryker, NJ, USA) of either CR (n=30) or PS (n=30) design. RSA measurements (primary outcome) and clinical scores including the Knee Society Score and Knee injury and Osteoarthritis Outcome Score were evaluated at baseline, at three months postoperatively and at one, two, five and seven years. A linear mixed-effects model was used to analyse the repeated measurements. Both groups showed a similar implant migration pattern, with a maximum total point motion at seven years follow-up of around 0.8 mm of migration (mean difference between groups 95% CI −0.11 to 0.15mm, p=0.842). Two components (one of each group) were considered to have an increased risk of aseptic loosening. Both groups improved equally after surgery on the KSS and KOOS scores and no differences were seen during the seven years of follow-up. No differences in implant migration nor clinical results were seen seven years after cruciate-retaining compared to posterior-stabilized total knee prostheses


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 26 - 26
1 Oct 2018
Dunbar MJ Laende E Richardson CG
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Introduction. Cementless fixation in total knee arthroplasty has been proposed to offer advantages long-term once osteointegration has occurred as there is no substrate between the implant and the bone to fail. Radiostereometric analysis (RSA) is a useful tool to study fixation, but typically focused on early migration in the first two post-operative years. Few studies have looked at 10-year RSA migration in cementless fixation and those that have contain small numbers of subjects. The objective of this study was to compare implant migration and inducible displacement between cemented and cementless TKA at 10 years and to compare the 10-year migration to the 2-year data in an effort to validate the predictive modelling of RSA. Methods. Subjects who had previously participated in RSA migration studies with 2-year follow-up were recruited to return for a long-term follow-up exam, at least 10 years from their surgery. The implants under study included two cemented designs from two manufacturers and one porous metal monoblock cementless design. At the 10-year visit, subjects had supine RSA exams to determine long-term migration as well as a loaded exam (single leg stance) to determine inducible displacement. Differences between cemented and cementless groups were evaluated with the Mann Whitney U test and Spearman's rank correlation coefficients were calculated for early and late migrations. Significance was set at p < 0.05. Results. Seventy-five subjects were available for long-term follow-up, with average time since surgery of 12 years. This cohort contained 51 women and 24 men with cemented tibial components in 53 cases (37 female) and cementless tibial components in 22 cases (14 female). At the time of surgery, the subjects were 62±7 years old with BMIs of 33±6 m/kg2 (mean±standard deviation). Median migration at the long-term follow-up was 0.6 mm (MTPM; range 0.2–2.8 mm) and was not different between the cemented and cementless groups (p = 0.9, Mann Whitney U Test). Inducible displacement at 10 years was significantly lower for the cementless implants (p<0.001, Figure 1). Migration at one, two, and 10 years did not correlate with inducible displacement at 10 years. However, migration at one year and two years did correlate with long-term migration, with the strongest correlation at two years (Spearman's rank correlation coefficient for all components = 0.74, p < 0.001, Figure 2). Conclusion. Although long-term migration was not different for cemented or cementless (porous metal monoblock) tibial components, inducible displacement at the 10-year visit was significantly lower for these cementless components, suggesting superior fixation. Additionally, long-term migration was strongly correlated to two-year migration, regardless of fixation. These findings support the predictive value of short-term migration in determining long-term fixation. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_1 | Pages 25 - 25
1 Jan 2018
Malchau H Galea V Connelly J Shareghi B Kärrholm J Sköldenberg O Laursen M Bragdon C Muratoglu O
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Osteolysis secondary to ultra-high molecular weight polyethylene (UHMWPE) wear is a leading cause of late-term implant failure via aseptic loosening in patients treated with total hip arthroplasty (THA). Radiation crosslinking of UHMWPE has been shown to decrease wear. However, the resulting polymer (crosslinked-PE) has a high free radical content. Two different methods that have been used to reduce the remaining free radicals are mechanical annealing and chemical stabilization using Vitamin E, a free radical scavenger. The primary purpose of the current study was to evaluate and compare the wear properties of vitamin E-doped crosslinked-PE (VEPE) and one formulation of mechanically annealed crosslinked-PE using radiostereometric analysis (RSA) in patients five years after primary THA. We also sought to understand the association between polyethylene wear and patient-reported outcome measures (PROMs). Three-hundred and five patients from six international centers were enrolled. Seventy-six percent were treated with highly-crosslinked (95 kGy) VEPE liners, and the rest received moderately-crosslinked (50 kGy) (ModXL), mechanically annealed liners. Data was collected prospectively at one-, two-, and five-year intervals. At the 5-year follow-up, proximal femoral head penetration into the VEPE liners (median = 0.05mm (range, −0.03–1.20)) was significantly lower than the penetration into the ModXL liners (median = 0.15mm (range, −0.22–1.04)) (p<0.001). In the VEPE cohort the median proximal penetration did not increase from one- to five-year follow-up (p=0.209). In contrast, there was a significant increase in femoral head penetration for the ModXL group (p<0.001) during that same time. Multivariable regression showed that the only variable predictive of increased wear was ModXL liner type (B=0.12, p<0.001). There were no differences in PROMs between the liner groups, and there was no correlation between polyethylene wear and PROMs for the cohort as a whole. The current study is the largest analysis of polyethylene wear at five-year follow-up using the RSA technique. We observed similar bedding in through the two-year interval between the two liner types, however, there was significantly more wear in the ModXL cohort at five-years. Currently, the wear rates for both liner groups are below the osteolysis threshold and have not led to any implant failures via aseptic loosening. Continued follow-up will provide a better understanding of the association between wear rate and clinical outcomes


The primary aim of this study was to determine dislocation and revision total hip replacement (THR) up to ten years following primary THR, as well as rates of polyethylene wear, in patients previously enrolled in a randomised controlled trial (RCT) which compared 28 mm and 36 mm metal on highly cross-linked polyethylene (XLPE) articulations. 328 primary THR patients were enrolled in the RCT in Australia. Dislocation was identified from hip instability and hospital visit questionnaires completed by patients or, if they were unable to do so, by their next of kin or primary carer, or General Practitioner. All reported dislocations were confirmed radiographically. Patients' names were cross-matched with the Australian National Joint Replacement Registry to determine whether the index hip had undergone revision THR. Linear wear was measured on plain radiographs using PolyWare (Rev 5, Draftware Developers, Vevay IN, USA). A separate RCT examined the mean proximal wear rate of 28 and 36 mm articulations using radiostereometric analysis (RSA). At 10 years, 110 patients were deceased and 3 patients were lost to follow-up. Overall, dislocation was identified in 8 of 167 (5%) patients with a 28 mm articulation and 2 of 158 (1%) patients with a 36 mm articulation. Three patients experienced recurrent dislocation; all had a 28 mm articulation. 320 (163 28 mm; 157 36 mm) patients were successfully cross-matched with Registry data to identify revision THR. Three patients, all with a 28 mm articulation, underwent revision because of dislocation. Other reasons for revision were infection (1:2), periprosthetic fracture (0:3), loosening/lysis (1:2) and liner fracture (0:1). Adequate radiographs were available to measure wear in 122 hips (67:55) using PolyWare. Excluding bedding in, the mean annual linear wear rate from 1–10 years was 0.04 mm/yr for both 28 and 36 mm articulations (p=0.48). The more sensitive RSA data indicated that at 7 years following primary THR, the mean annual wear rate did not exceed 0.02 mm/yr with either articulation. Up to 10 years following primary THR, 36 mmm articulations were associated with fewer dislocations and revisions for dislocation and did not increase the mean annual linear wear rate


The Bone & Joint Journal
Vol. 97-B, Issue 11 | Pages 1463 - 1469
1 Nov 2015
Jonsson BA Kadar T Havelin LI Haugan K Espehaug B Indrekvam K Furnes O Hallan G

We report the five-year outcome of a randomised controlled trial which used radiostereometric analysis (RSA) to assess the influence of surface oxidised zirconium (OxZr, Oxinium) on polyethylene wear in vivo. A total of 120 patients, 85 women and 35 men with a mean age of 70 years (59 to 80) who were scheduled for primary cemented total hip arthroplasty were randomly allocated to four study groups. Patients were blinded to their group assignment and received either a conventional polyethylene (CPE) or a highly cross-linked (HXL) acetabular component of identical design. On the femoral side patients received a 28 mm head made of either cobalt-chromium (CoCr) or OxZr. . The proximal head penetration (wear) was measured with repeated RSA examinations over five years. Clinical outcome was measured using the Harris hip score. . There was no difference in polyethylene wear between the two head materials when used with either of the two types of acetabular component (p = 0.3 to 0.6). When comparing the two types of polyethylene there was a significant difference in favour of HXLPE, regardless of the head material used (p < 0.001). . In conclusion, we found no advantage of OxZr over CoCr in terms of polyethylene wear after five years of follow-up. Our findings do not support laboratory results which have shown a reduced rate of wear with OxZr. They do however add to the evidence on the better resistance to wear of HXLPE over CPE. Cite this article: Bone Joint J 2015;97-B:1463–9


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_1 | Pages 26 - 26
1 Jan 2018
MacDonald S Howard J Goyal P Yuan X Lanting B Teeter M Naudie D McCalden R
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Lewinnek's safe zone recommendation to minimise dislocations was a target of 5–25° for anteversion angle and 30–50° for inclination angle. Subsequently, it was demonstrated that mal-positioning of the acetabular cup can also lead to edge loading, liner fracture, and greater conventional polyethylene wear. The purpose of this study was to measure the effect of acetabular cup position on highly crosslinked polyethylene wear in total hip arthroplasty (THA) at long-term follow-up. We identified all patients that underwent primary THA with a minimum of 10 years follow-up using an institutional database in London, Ontario, Canada. Patients with a single implant design consisting of a 28 mm cobalt chromium head and highly crosslinked polyethylene liner (ram extruded, GUR 1050, 100 kGy gamma irradiated, remelted, ethylene oxide sterilised) were selected for inclusion. In total, 85 hips from 79 recruited patients were analysed. Patients underwent a supine radiostereometric analysis (RSA) exam in which the x-ray sources and detectors were positioned to obtain an anterior-posterior and cross-table lateral radiograph. Acetabular cup anteversion angle, inclination angle, and 3D penetration rate (including wear and creep) were measured from the stereo radiograph pairs. At a mean follow-up of 13 years (range, 10–17 years) the mean penetration rate was 0.059 mm/year (95% CI: 0.045 to 0.073 mm/year). Mean anteversion angle was 18.2° (range, −14 to 40°) and mean inclination angle was 43.6° (range, 27 to 61°). With respect to the Lewinnek safe zone, 67% hips met the target for anteversion angle, 77% met the target for inclination angle, and 51% met the target for both. There was no correlation between anteversion angle and penetration rate (r = −0.14, p = 0.72) or between inclination angle and penetration rate (r = 0.11, p = 0.35). There was also no difference (p = 0.07) in penetration rate between hips located within the Lewinnek safe zone for both anteversion angle and inclination angle (mean 0.057 mm/year, 95% CI: 0.036 to 0.079 mm/year) and those outside the safe zone (mean 0.062 mm/year, 95% CI: 0.042 to 0.083 mm/year). Acetabular cup position had no effect on the wear rate of highly crosslinked polyethylene at long-term follow-up. Although care should still be taken to correctly position the acetabular cup for stability, highly crosslinked polyethylene is a forgiving bearing material that can withstand a wide range of cup positions without negatively impacting longevity due to wear


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_11 | Pages 57 - 57
1 Oct 2019
Broberg JS Teeter MG Lanting B Vasarhelyi EM Howard JL Yuan X Naudie DDR
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Introduction. Surgeons performing a total knee replacement (TKR) have two techniques to assist them achieve proper bone resections and ligament tension – gap balancing (GB) and measured resection (MR). GB relies on balancing ligaments prior to bony resections, whereas bony resections are made based on anatomical landmarks in MR. Many studies have been done to compare the implant migration and kinematics between the two techniques, but the results have been varied. However, these studies have not been done on modern anatomically designed prostheses using radiostereometric analysis (RSA). Anatomical designs attempt to mimic the normal knee joint structure to return more natural kinematics to the joint, with emphasis on eliminating both paradoxical anterior motion and reduced posterior femoral rollback. Given the major design differences between anatomical and non-anatomical prostheses, it is important to investigate whether one surgical technique may have advantages another. We hypothesize that there would be no difference between GB and MR techniques in implant migration, but that GB might provide better knee kinematics. Methods. Patients were recruited to receive an anatomically designed prosthesis and randomized to groups where the GB or MR technique is used. For all patients in the study, RSA images were acquired at a 2 week baseline, as well as at 6 weeks, 3 months, and 6 months post-operatively. These images were used to collect the maximum total point motion (MTPM) of the tibial and femoral implant components relative to the bone using a model-based RSA software. A series of RSA images were also acquired at 3-months post-operatively at different knee flexion angles, ranging in 20° increments from 0° to 100°. Model-based RSA software was used to obtain the 3D positions and orientations of the femoral and tibial components, which were used to obtain the anterior-posterior (AP) contact locations for each condyle. Results. Results from 47 patients (27 GB, 20 MR) were analyzed. No significant differences were present between the two surgical techniques for tibial component MTPM at 6 weeks (mean difference=0.02 mm, p=0.61), 3 months (mean difference=0.01 mm, p=0.92), and 6 months (mean difference=0.01 mm, p=0.93) post-operatively. No significant differences were present between the two surgical techniques for femoral component MTPM at 6 weeks (mean difference=0.12 mm, p=0.08), 3 months (mean difference=0.05 mm, p=0.54), and 6 months (mean difference=0.13 mm, p=0.05) post-operatively. On the medial condyle, no significant differences in AP contact location were found at all angles between 0° and 80° of flexion (p-values from 0.28 to 0.95). There was a significant difference medially between the AP contact location of the two surgical techniques at 100° of flexion (p=0.01), indicating more posterior rollback on the medial condyle in the GB technique. On the lateral condyle, no significant differences in AP contact location were found at all angles of flexion (p-values from 0.13 to 0.62). On the medial condyle of the GB group, the AP contact location moved posteriorly 5.83 mm from 0° to 20°, anteriorly 2.60 mm from 20° to 60°, and posteriorly 7.40 mm from 60° to 100°. On the medial condyle of the MR group, the AP contact location moved posteriorly 5.36 mm from 0° to 20°, anteriorly 2.87 mm from 20° to 60°, and posteriorly 3.65 mm from 60° to 100°. On the lateral condyle of the GB group, the AP contact location moved posteriorly 6.87 mm from 0° to 20°, 0.30 mm from 20° to 60°, and 3.61 mm from 60° to 100°. On the lateral condyle of the MR group, the AP contact location moved posteriorly 6.86 mm from 0° to 20°, anteriorly 0.02 mm from 20° to 60°, and posteriorly 3.56 mm from 60° to 100°. Conclusions. The GB and MR techniques are very similar in terms of implant migration and overall kinematics when an anatomical prosthesis design is used for TKR. This study suggests that surgeon preference should be used when deciding which technique to use for implanting this anatomically designed knee replacement. For figures, tables, or references, please contact authors directly


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 57 - 57
1 Dec 2016
Laende E Dunbar M Richardson G Reardon G Amirault D
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The trabecular metal Monoblock TKR is comprised of a porous tantalum base plate with the polyethylene liner embedded directly in the porous metal. An alternative design, the trabecular metal Modular TKR, allows polyethylene liner insertion into the locking base plate after base plate implantation, but removes the low modulus of elasticity that was inherent in the Monoblock design. The purpose of this study was to compare the fixation of the Monoblock and Modular trabeucular metal base plates in a randomised controlled trial. Fifty subjects (30 female) were randomly assigned to receive the uncemented trabecular metal Monoblock or uncemented trabecular metal Modular knee replacement. A standard procedure of tantalum marker insertion in the proximal tibial and polyethylene liner was followed with uniplanar radiostereometric analysis (RSA) examinations immediately post-operatively and at 6 week, 3 month, 6 month, and 12 month follow-ups. The study was approved by the Research Ethics Board and all subjects signed an Informed Consent Form. Twenty-one subjects received Monoblock components and 20 received Modular components. An intra-operative decision to use cemented implants occurred in 5 cases and 4 subjects did not proceed to surgery after enrollment. The clinical precision of implant migration measured as maximum total point motion (MTPM) was 0.13 mm (upper limit of 95% confidence interval of double exams). Implant migration at 12 months was 0.88 ± 0.64 mm (mean and standard deviation; range 0.21 – 2.84 mm) for the Monoblock group and 1.60 ± 1.51 mm (mean and standard deviation; range 0.27 – 6.23 mm) for the Modular group. Group differences in 12 month migration approached clinical significance (p = 0.052, Mann Whitney U-test). High early implant migration is associated with an increased risk for late aseptic loosening. Although not statistically significant, the mean migration for the Modular component group was nearly twice that of the Monoblock, which places it at the 1.6 mm threshold for “unacceptable” early migration (Pijls et al 2012). This finding is concerning in light of the recent recall of a similar trabecular metal modular knee replacement and adds validity to the use of RSA in the introduction of new or modified implant designs. Reference: Pijls, B.G., et al., Early migration of tibial components is associated with late revision: a systematic review and meta-analysis of 21,000 knee arthroplasties. Acta Orthop, 2012. 83(6): p. 614–24


The Bone & Joint Journal
Vol. 97-B, Issue 5 | Pages 595 - 602
1 May 2015
McCalden RW Korczak A Somerville L Yuan X Naudie DD

This was a randomised controlled trial studying the safety of a new short metaphyseal fixation (SMF) stem. We hypothesised that it would have similar early clinical results and micromovement to those of a standard-length tapered Synergy metaphyseal fixation stem. Using radiostereometric analysis (RSA) we compared the two stems in 43 patients. A short metaphyseal fixation stem was used in 22 patients and a Synergy stem in 21 patients. No difference was found in the clinical outcomes pre- or post-operatively between groups. RSA showed no significant differences two years post-operatively in mean micromovement between the two stems (except for varus/valgus tilt at p = 0.05) (subsidence 0.94 mm (. sd.  1.71) vs 0.32 mm (. sd. 0.45), p = 0.66; rotation 0.96° (. sd. 1.49) vs 1.41° (. sd. 2.95), p = 0.88; and total migration 1.09 mm (. sd. 1.74) vs 0.73 mm (. sd. 0.72), p = 0.51). A few stems (four SMF and three Synergy) had initial migration > 1.0 mm but stabilised by three to six months, with the exception of one SMF stem which required revision three years post-operatively. For most stems, total micromovement was very low at two years (subsidence < 0.5 mm, rotation < 1.0°, total migration < 0.5 mm), which was consistent with osseous ingrowth. The small sample makes it difficult to confirm the universal applicability of or elucidate the potential contraindications to the use of this particular new design of stem. Cite this article: Bone Joint J 2015; 97-B:595–602


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 55 - 55
1 Dec 2016
Lanting B Thoren J Yuan X McCalden R McAuley J MacDonald S Vasarhelyi E Howard J Naudie D Teeter M
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Adequate fixation of implant components is an important goal for all arthroplasty procedures. Aseptic loosening is one of the leading causes of revision surgery in total knee arthroplasty. Radiostereometric analysis (RSA) is an imaging technique to measure implant migration, with established migration thresholds for well-fixed, at risk, and unacceptably migrating components. The purpose of the present study was to examine the long-term fixation of a cemented titanium fixed bearing polished tibial baseplate. Patients enrolled in a previous two-year prospective trial were recalled at ten years. All patients received a cemented, posterior-stabilised total knee replacement of the same design implanted by one of three surgeons. Of the original 35 patients, 16 were available for long-term follow-up, with one patient lost to follow-up, nine patients deceased, and a further nine patients unwilling to return to the clinic. Each patient underwent RSA imaging in a supine position using a conventional RSA protocol. Migration of the tibial component in all planes as well as maximum total point motion (MTPM) was compared between all time points (baseline, six weeks, three months, six months, one year, two years) up to the ten year follow-up visits. Outcome scores including the Knee Society Score (KSS), WOMAC, SF-12, and UCLA Activity Score were recorded. At ten years, the mean migrations of the tibial component were less than 0.1 mm and 0.1 degree in all planes relative to the post-operative RSA exam. There was no significant difference in tibial component migration between time points. However, MTPM increased significantly over time (p = 0.002), from 0.23 ± 0.18 mm at six weeks to 0.42 ± 0.20 mm at ten years. At one year, 13 patients had an acceptable MTPM level, three patients had an ‘at risk’ level, and no patient had an ‘unacceptable’ level. No patients were revised at ten years. WOMAC and KSS were significantly improved (p < 0.0001) at the latest follow-up compared to pre-operatively, but there was no difference in SF-12. The median UCLA Activity Score at latest follow-up was six (range, two to eight). The tibial baseplate demonstrated solid fixation at ten years. No patients had an unacceptable MTPM level at one year and no patients were revised at ten years, supporting the use of RSA to predict long-term loosening risk. The low level of tibial baseplate migration found in the present study correlates to the low rate of revision for this implant as reported in individual studies and in joint replacement registries


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 52 - 52
1 Oct 2018
Naudie DD Broberg JS Howard JL Vasarhelyi EM Yuan X McCalden RW Teeter MG
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Introduction. The effectiveness of patient specific instrumentation (PSI) to perform total knee arthroplasty (TKA) remains controversial. Multiple studies have been published that reveal conflicting results on the effectiveness of PSI, but no study has analyzed the contact kinematics within knee joints replaced with the use of PSI. Since a departure from normal kinematics can lead to eccentric loading, premature wear, and component loosening, studying the kinematics in patients who have undergone TKA with PSI can provide valuable insight on the ability of PSI to improve functionality and increase longevity. The goal of the present study was to compare femoral and tibial component migration (predictive of long-term loosening and revision) and contact kinematics following TKA using conventional instruments (CI) and PSI based surgical techniques. Methods. The study was designed as a prospective, randomized controlled trial of 50 patients, with 25 patients each in the PSI and CI groups, powered for radiostereometric analysis (RSA). Patients in the PSI group received an MRI and standing 3-foot x-rays to construct patient-specific cut-through surgical guides for the femur and tibia with a mechanical limb alignment. All patients received the same posterior-stabilized implant with marker beads inserted in the bone around the implants to enable RSA imaging. Patients underwent supine RSA exams at multiple time points (two and six weeks, three and six months, and one and two years). At 2 years post-op, a series of RSA radiographs were acquired at different knee flexion angles, ranging in 20° increments from 0° to 120°, to measure the tibiofemoral contact kinematics. Migrations of the femoral and tibial components were calculated using model-based RSA software. Kinematics were measured for each condyle for magnitude of excursion, contact location, and stability. Results. There were no differences (p > 0.05) between the PSI and CI groups for demographics or pre- and post-operative patient reported outcome scores. Three patients in the PSI group and seven patients in the CI group (p = 0.28) had a post-operative limb alignment outside of the neutral target (>3° varus or valgus). There was no difference in the change of tibial slope from pre- to post-operation between groups (p = 0.49). There were no differences (p > 0.05) in translations or rotations in any individual plane across all time points for either the tibial or femoral components. Maximum total point motion (MTPM) at 6 months for the tibial component was 0.54 ± 0.25 mm in the CI group and 0.51 ± 0.22 mm in the PSI group (p = 0.77), placing both groups at the low end of the “at risk” category for predicted loosening. Change in MTPM from 6 months to 1 year and again from 1 year to 2 years was <0.2 mm, indicating both groups of implants had stable fixation. Femoral component MTPM was also not different (p > 0.05) between groups. There was no significant difference between PSI and CI groups with respect to magnitude of excursion on both medial (p = 0.54) and lateral (p = 0.81) condyles. There was also no difference in contact locations on both the medial and lateral condyles (p = 0.28 to 0.91) for all angles of flexion. There was no significant difference present between PSI and CI groups when comparing the stability for both the medial (p = 0.06) and lateral (= 0.85) condyles. Condylar separation was present in 3/20 CI patients and 0/16 PSI patients (p = 0.24). Conclusion. Using the latest RSA criteria for predicting failure from early migration, the use of PSI does not provide an advantage over CI for preventing aseptic loosening. Moreover, PSI did not provide any substantial advantage over CI for TKA surgery with respect to contact kinematics


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_20 | Pages 64 - 64
1 Nov 2016
Teeter M Naudie D McCalden R Yuan X MacDonald S
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The philosophy of cemented total hip arthroplasty (THA) femoral components has become polarised. At one extreme are polished, collarless, tapered devices that are expected to subside; at the other extreme are roughened, non-tapered implants with a collar designed not to subside. Radiostereometric analysis (RSA) allows the accurate measurement of implant movement and has been extensively used for measurement of the in vivo migration of implants. The degree of migration as measured by RSA during the first years after surgery has been shown to correlate with the long-term performance of cemented femoral implants. The purpose of this study was to review the two-year RSA results of two different designs of primary cemented THA stems. Data from two previous prospective RSA trials with two-year follow-up were pooled. The first group included 36 patients who received a Spectron (Smith & Nephew, Memphis, USA) cemented stem. The second group included 13 patients who received an Exeter (Stryker, Mahwah, USA) cemented stem, and 15 patients who received a CPCS (Smith & Nephew, Memphis, USA) cemented stem. All patients underwent RSA examinations shortly post-operation, at 6 weeks, 3 months, 6 months, 1 years, and 2 years. Migration and rotation of the femoral stems was measured at each time point relative to the post-operative exam, and compared between the two groups. There was no difference in age at surgery (Spectron 78 ± 6 years, Exeter/CPCS 77 ± 5 years, p = 0.43), BMI (Spectron and Exeter/CPCS 28 ± 5 kg/m2, p = 0.92), or percentage of male patients (Spectron 23% male, Exeter/CPCS 21% male) between the implant groups. Subsidence was significantly greater (p < 0.0001) at all time points from three months to two years for the Exeter and CPCS stems (0.94 ± 0.39 mm at two years) compared to the Spectron stem (0.05 ± 0.16 mm at two years). There was no significant difference between the stem types for medial-lateral translation (p = 0.07) or anterior-posterior translation (p = 0.49), or for anterior-posterior tilt (p = 0.15), internal-external rotation (p = 0.89), or varus-valgus rotation (p = 0.05). Implant material, design, and surface finish are all factors in the long-term performance of cemented femoral hip implants. In this study, both femoral stem designs had a magnitude of sub-sidence that was within the limits of what is considered to be safe with respect to long-term performance. The continuous subsidence of the Exeter and CPCS stems is consistent with previous reports in the literature


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_20 | Pages 5 - 5
1 Nov 2016
Teeter M Lam K Howard J Lanting B Yuan X
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Radiostereometric analysis (RSA) has become the gold standard technique for measuring implant migration and wear following joint replacement due to its high measurement precision and accuracy. However, RSA is conventionally performed using two oblique radiographic views with the presence of a calibration cage. Thus, a second set of radiographs must be acquired for clinical interpretation, for example anterior-posterior and cross-table lateral views following total hip arthroplasty (THA). We propose a modification to the RSA setup for examining THA, in which RSA measurements are performed from anterior-posterior and lateral views, with the calibration cage images acquired separately from the patient images. The objective of the current study was to compare the accuracy and precision of the novel technique to the conventional technique using a phantom. X-ray cassette holders were developed to enable simultaneous acquisition of anterior-posterior and cross-table lateral radiographs with the patient in a supine position in the RSA suite. A Sawbones phantom with total hip implant components was attached to a micrometer-driven stage. The femoral component was translated known distances relative to the acetabular cup in all planes, mimicking head penetration due to wear. Double RSA examinations were acquired for each increment using the traditional and novel radiograph orientations. Translations were measured from the radiographic images using RSA software. For both techniques, accuracy was calculated by comparing the measured translations to the known translation from the micrometer, and reported as the 95% confidence interval. Precision was measured by comparing the measured translations between the double exams, and reported as the standard deviation. Accuracy was greater for the conventional technique in the inferior-superior axis (p = 0.03), greater for the novel technique in the anterior-posterior axis (p = 0.01), and equivalent in the medial-lateral axis (p = 0.06). Overall accuracy for both the conventional and novel techniques was identical at ±0.022 mm. Precision was equivalent between both techniques for the medial-lateral (p = 0.68), inferior-superior (p = 0.14), and anterior-posterior axes (p = 0.86). Overall precision for the conventional technique was ±0.127 mm and for the novel technique was ±0.095 mm. Utilising standard clinical radiograph view angles within an RSA exam had no detrimental effect on wear measurement accuracy or precision. This reduces the barriers to implementing RSA imaging in routine follow-up of arthroplasty patients, potentially greatly increasing the numbers of patients that can have quantitative data on implant performance. Future applications can involve applying more clinically relevant radiograph view angles to RSA exams of the knee and shoulder


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_8 | Pages 35 - 35
1 May 2016
Heesterbeek P Kaptein B Wymenga A
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Introduction. Measuring the step off during total knee replacement (TKR) is a newly developed operative strategy (“spacer technique”; Heesterbeek et al, KSSTA 2014;22(3):650–9) to determine the optimal contact point (CP) of the femur with the tibia postoperative and to balance the posterior cruciate ligament (PCL) in cruciate-retaining TKR. Engineers have calculated the ideal step off for every size of the TKR, for which the tibiofemoral contact point in 90° will be at the designed position. With this study we determined the postoperative CP in CR-TKA and investigated whether (adverse) clinical outcome was correlated with the CP. Methods. 23 patients presenting with non-inflammatory osteoarthritis, a good functioning PCL, and indication for surgery with a PCL-retaining TKR were selected. Intraoperative PCL balancing was performed with the spacer technique. At 3 months postoperative, a pair of mediolateral radiographs was made using a set-up used for radiostereometric analysis (RSA). The patient was positioned standing with the operated leg in 90 degrees, 50% weight-bearing, knee flexion on a 30 cm-step. Model-based RSA software (RSAcore) was used to determine the 3D positions of the femur and tibia component, that were exported to custom-written software for determining the CP. The CP was defined as the point with the smallest distance between both the medial and lateral femur condyles and tibia plateau. It is expressed as the ratio of the anterior-posterior CP distance and the maximum anterior-posterior tibia plateau size, with 0 being anterior, 1 being posterior. Patients with reduced flexion capacity at follow-up, leading to manipulation under anaesthesia and/or scopic releases, were categorized as COMP, the other patients as no-COMP. CP was compared between these groups. Results. Preliminary data show that the mean medial CP of the total group was 0.51 (sd 0.05), mean lateral CP was 0.61 (sd 0.03) (p<0.001). Six out of 23 patients had flexion-related complications and for this reason further patient inclusion was stopped. The medial CP of the COMP-group (n=6) was at 0.54 (sd 0.01), which was significantly more posterior than the medial CP of the no-COMP group (n=17) (0.50 (sd 0.05)) (p=0.004). (Figure 1) The lateral CP was similar for both groups (p=0.76). Discussion. The medial CP relates to clinical outcome; patients with reduced flexion capacity had a more posterior CP. This might be an indication for a too tightly balanced PCL, but we need to investigate this further. None of the patients had a medial CP at the theoretically optimal position


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 137 - 137
1 Jan 2016
Laende E Richardson G Biddulph M Dunbar M
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Introduction. Debate over appropriate alignment in total knee arthroplasty has become a topical subject as technology allows planned alignments that differ from a neutral mechanical axis. These surgical techniques employ patient-specific cutting blocks derived from 3D reconstructions of pre-operative imaging, commonly MRI or CT. The patient-specific OtisMed system uses a detailed MRI scan of the knee for 3D reconstruction to estimate the kinematic axis, dictating the cutting planes in the custom-fit cutting blocks machined for each patient [1, 2]. The purpose of this study was to evaluate the correlation between post-operative limb alignment and implant migration in subjects receiving shape match derived kinematic alignment. Methods. In a randomized controlled trial comparing patient-specific cutting blocks to navigated surgery, seventeen subjects in the patient specific group had complete 1 year data. They received cruciate retaining cemented total knee replacements (Triathlon, Stryker) using patient-specific cutting blocks (OtisMed custom-fit blocks, Stryker). Intra-operatively, 6–8 tantalum markers (1 mm diameter) were inserted in the proximal tibia. Radiostereometric analysis (RSA) [3, 4] exams were performed with subjects supine on post-operative day 1 and at 6 week, 3, 6, and 12 month follow-ups with dual overhead tubes (Rad 92, Varian Medical Systems, Inc., Palo Alto, CA, USA), digital detectors (CXDI-55C, Canon Inc., Tokyo, Japan), and a uniplanar calibration box (Halifax Biomedical Inc., Mabou, NS, Canada). RSA exams were analyzed in Model-based RSA (Version 3.32, RSAcore, Leiden, The Netherlands. Post-operative limb alignment was evaluated from weight-bearing long-leg films. Results. Post-operative limb alignments ranged from 5 degrees of varus to 5 degrees of valgus. Comparing implant migration to post-operative alignment did not demonstrate a relationship between deviation from neutral mechanical alignment and increased migration (Pearson correlation coefficient = 0.25, P = 0.33) (Figure 1). Conclusions. Previous studies have suggested that alignment of greater than 3 degrees from neutral may have adverse effects on implant survivorship [5], but this early data does not suggest increased migration with non-neutral alignment. Continued evaluation with RSA to 2 years will be performed to monitor these subjects over the longer term


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 138 - 138
1 Jan 2016
Laende E Dunbar M Richardson G Biddulph M
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Introduction. The dual mobility design concept for acetabular liners is intended to reduce the risk of dislocation and increase range of motion, but the wear pattern of this design is unclear and may have implications in implant fixation. Additionally, the solid back cups do not have the option for supplementary screw fixation, providing an additional smooth articulating surface for the liner to move against. The objective of this study was to assess cup fixation by measuring implant migration. A secondary objective was to evaluate the mobile bearing motion after rotating the hip. Methods. Thirty subjects were recruited in a consecutive series prospective study and received Anatomic Dual Mobility (Stryker Orthopedics) uncemented acetabular components with mobile bearing polyethylene liners through a direct lateral approach. Femoral stems were cemented (Exeter) or uncemented (Accolade, Stryker Orthopedics). The femur, acetabulum, and non-articulating surface of the polyethylene liner were marked with tantalum beads. Radiostereometric analysis (RSA) exams were performed post-operatively and at 6 weeks, 3, 6, months, and at 1 year. At the 1 year exam, a frog leg RSA exam was performed to assess the mobility of the cup compared to its position during a supine exam. Results. Proximal translation of the cup was 0.16 ± 0.28 mm (range −0.18 to 0.92 mm) and sagittal rotation was 0.08 ± 0.86 degrees (range −1.81 to 2.18 degrees) at 1 year. Analysis of the motion of the mobile bearing liner during the frog leg RSA exam showed total motions of between 0.10 to 5.58 mm (maximum total point motion). Discussion & Conclusions. The migration of the cup has a low group average and is on track to be in the “acceptable” range as defined by Pijls et al. [1] of less than 0.2 mm of subsidence at 2 years. The combination of low subsidence and low sagittal rotations of the cup are favorable predictors of good long-term performance [2]. The wide range of motions of the mobile bearing suggest that in some patients the liner is moving freely, while in a subset of subjects there is no motion. The implications of this in terms of the generation of wear particles and affect on implant migration will be monitored to 3 years


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 83 - 83
1 Feb 2017
Kosse N Van Hellemondt G Wymenga A Heesterbeek P
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Introduction. The number of revisions of total knee replacements (TKR) increases annually. Because of reduced bone stock, stable fixation of the implant is important. The femoral and tibial components are usually cemented whereas stems can be placed either cemented or press-fit (hybrid construct). To assess the stability of revision TKR with either cemented or hybrid places implants a randomized controlled trial (RCT) was executed, by using radiostereometric analysis (RSA). The short-term results of this RCT showed no differences between the two groups in stability and clinical outcomes. Although there were no clinical or radiological signs of loosening, both groups showed implants micromotion > 1 mm or degree. These findings might indicate the possibility of loosening later in time; therefore, the current study investigated the stability of cemented versus hybrid-placed revision TKR 6.5 years after surgery. Additionally, clinical results were evaluated. Methods. Of the 32 patients in the original RCT, 23 (12 cement, 11 press-fit) were available for mid-term follow-up measures. RSA images taken at baseline, 6 weeks, 3, 6, 12 and 24 months postoperatively were used from the previous study. New RSA images were taken at median 6.5 years (range 5.4–7.3) postoperatively. Stability of the femoral and tibial implants was assessed by using model-based RSA software (RSAcore, Leiden, The Netherlands) to determine micromotion. Clinical results were evaluated using the Knee Society Score (KSS), the Knee injury and Osteoarthritis Outcome Score (KOOS), active flexion, and VAS pain and satisfaction. Stability and clinical outcome were compared between the two groups using independent t-tests or Mann-Whitney U tests when applicable. Results. The median total translation at 6.5 years was 0.37 (0.13–1.96) mm and median total rotation 0.62 (0.11 – 2.81)° for the femoral component. For the tibia component the median total translation was 0.41 (0.10 – 1.04) mm and the median total rotation 0.61 (0.09 – 1.99)°. There were no differences in total translation and total rotation of the femoral and tibial component between the two groups. Additionally, none of the clinical scores differed between the groups. Interestingly, in the group with cemented stems five tibia implants showed > 1 mm or degree migration compared to zero in the hybrid group (p=0.02; Figure 1). Conclusion. There was no difference in stability and clinical outcome between fully cemented and hybrid-placed revision TKR 6.5 years postoperatively. Until now micromotion >1 mm or degree in the tibial components of the cemented group has not yet resulted in re- revisions. The patients will be followed to examine the consequences of these amounts of micromotion in this type of implant in the long-term. Figure 1. Scatter plot of total translation (x-axis) and total rotation (y-axis) for the tibia component at 6.5 years follow-up for fully cemented and hybrid-placed revision TKA