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Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 43 - 43
1 Aug 2020
Laende E Dunbar MJ Richardson G
Full Access

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_6 | Pages 49 - 49
1 Jul 2020
Gascoyne T Parashin S Teeter M Bohm E Laende E Dunbar MJ Turgeon T
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The purpose of this study was to examine the influence of weight-bearing on the measurement of in vivo wear of total knee replacements using model-based RSA at 1 and 2 years following surgery.

Model-based RSA radiographs were collected for 106 patients who underwent primary TKR at a single institution. Supine RSA radiographs were obtained post-operatively and at 6-, 12-, and 24-months. Standing (weight-bearing) RSA radiographs were obtained at 12-months (n=45) and 24-months (n=48). All patients received the same knee design with a fixed, conventional PE insert of either a cruciate retaining or posterior stabilized design. Ethics approval for this study was obtained.

In order to assess in vivo wear, a highly accurate 3-dimensional virtual model of each in vivo TKA was developed. Coordinate data from RSA radiographs (mbRSA v3.41, RSACore) were applied to digital implant models to reconstruct each patient's replaced knee joint in a virtual environment (Geomagic Studio, 3D Systems). Wear was assessed volumetrically (digital model overlap) on medial and lateral condyles separately, across each follow-up. Annual rate of wear was calculated for each patient as the slope of the linear best fit between wear and time-point. The influence of weight-bearing was assessed as the difference in annual wear rate between standing and supine exams. Age, BMI, and Oxford-12 knee improvement were measured against wear rates to determine correlations.

Weight bearing wear measurement was most consistent and prevalent in the medial condyle with 35% negative wear rates for the lateral condyle. For the medial condyle, standing exams revealed higher mean wear rates at 1 and 2 years, supine, 16.3 mm3/yr (SD: 27.8) and 11.2 mm3/yr (SD: 18.5) versus standing, 51.3 mm3/yr (SD: 55.9) and 32.7 mm3/yr (SD: 31.7). The addition of weight-bearing increased the measured volume of wear for 78% of patients at 1 year (Avg: 32.4 mm3/yr) and 71% of patients at 2 years (Avg: 48.9 mm3/yr). There were no significant (95% CI) correlations between patient demographics and wear rates.

Volumetric, weight-bearing wear measurement of TKR using model-based RSA determined an average of 33 mm3/yr at 2 years post-surgery for a modern, non-cross-linked polyethylene bearing. This value is comparable to wear rates obtained from retrieved TKRs. Weight-bearing exams produced better wear data with fewer negative wear rates and reduced variance. Limitations of this study include: supine patient imaging performed at post-op, no knee flexion performed, unknown patient activity level, and inability to distinguish wear from plastic creep or deformation under load. Strengths of this study include: large sample size of a single TKR system, linear regression of wear measurements and no requirement for implanted RSA beads with this method. Based on these results, in vivo volumetric wear of total knee replacement polyethylene can be reliably measured using model-based RSA and weight-bearing examinations in the short- to mid–term. Further work is needed to validate the accuracy of the measurements in vivo.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 73 - 73
1 Feb 2020
Gascoyne T Parashin S Teeter M Bohm E Laende E Dunbar M Turgeon T
Full Access

Purpose

The purpose of this study was to examine the influence of weight-bearing on the measurement of in vivo wear of total knee replacements using model-based RSA at 1 and 2 years following surgery.

Methods

Model-based RSA radiographs were collected for 106 patients who underwent primary TKR at a single institution. Supine RSA radiographs were obtained post-operatively and at 6-, 12-, and 24-months. Standing (weight-bearing) RSA radiographs were obtained at 12-months (n=45) and 24-months (n=48). All patients received the same knee design with a fixed, conventional PE insert of either a cruciate retaining or posterior stabilized design. Ethics approval for this study was obtained.

In order to assess in vivo wear, a highly accurate 3-dimensional virtual model of each in vivoTKA was developed. Coordinate data from RSA radiographs (mbRSA v3.41, RSACore) were applied to digital implant models to reconstruct each patient's replaced knee joint in a virtual environment (Geomagic Studio, 3D Systems). Wear was assessed volumetrically (digital model overlap) on medial and lateral condyles separately, across each follow-up. Annual rate of wear was calculated for each patient as the slope of the linear best fit between wear and time-point. The influence of weight-bearing was assessed as the difference in annual wear rate between standing and supine exams. Age, BMI, and Oxford-12 knee improvement were measured against wear rates to determine correlations.


The Bone & Joint Journal
Vol. 101-B, Issue 11 | Pages 1348 - 1355
1 Nov 2019
Gascoyne T Parashin S Teeter M Bohm E Laende E Dunbar M Turgeon T

Aims

A retrospective study was conducted to measure short-term in vivo linear and volumetric wear of polyethylene (PE) inserts in 101 total knee arthroplasty (TKA) patients using model-based radiostereometric analysis (MBRSA).

Patients and Methods

Nonweightbearing supine RSA exams were performed postoperatively and at six, 12, and 24 months. Weightbearing standing RSA exams were performed on select patients at 12 and 24 months. Wear was measured both linearly (joint space) and volumetrically (digital model overlap) at each available follow-up. Precision of both methods was assessed by comparing double RSA exams. Patient age, sex, body mass index, and Oxford Knee Scores were analyzed for any association with PE wear.


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.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 61 - 61
1 Dec 2016
Gascoyne T Parashin S Turgeon T Bohm E Laende E Dunbar M
Full Access

Articulation of the polyethylene (PE) insert between the metal femoral and tibial components in total knee replacements (TKR) results in wear of the insert which can necessitate revision surgery. Continuous PE advancements have improved wear resistance and durability increasing implant longevity. Keeping up with these material advancements, this study utilises model-based radiostereometric analysis (mbRSA) as a tool to measure in vivo short-term linear PE wear to thus predict long-term wear of the insert.

Radiographic data was collected from the QEII Health Sciences Centre in Halifax, NS. Data consisted of follow-up RSA examinations at post-operative, six-, 12-, and 24-month time periods for 72 patients who received a TKR. Implanted in all patients were Stryker Triathlon TKRs with a fixed, conventional PE bearing of either a cruciate retaining or posterior stabilised design. Computer-aided design (CAD) implant models were either provided by the manufacturer or obtained from 3D scanned retrieved implants. Tibial and femoral CAD models were used in mbRSA to capture pose data in the form of Cartesian coordinates at all follow-ups for each patient. Coordinate data was manually entered into a 3D modeling software (Geomagic Studio) to position the implant components in virtual space as presented in the RSA examinations. PE wear was measured over successive follow-ups as the linear change in joint space, defined as the shortest distance between the tibial baseplate and femoral component, independently for medial and lateral sides. A linear best-fit was applied to each patient's wear data; the slope of this line determined the annual wear rate per individual patient. Wear rates were averaged to provide a mean rate of in vivo wear for the Triathlon PE bearing.

Mean linear wear per annum across all 72 patients was 0.088mm/yr (SD: 0.271 mm/yr) for the medial condyle and 0.032 mm/yr (SD: 0.230 mm/yr) for the lateral condyle. Cumulative linear wear at the 2-year follow-up interval was 0.207mm (SD: 0.565mm) and 0.068mm (SD: 0.484mm) for the medial and lateral condyles, respectively.

Linear PE wear measurements using mbRSA and Geomagic Studio resulted in 0.056mm/yr additional wear on the medial condyle than the lateral condyle. Large standard deviations for yearly wear rates and cumulative measurements demonstrate this method does not yet exhibit the accuracy needed to provide short-term in vivo wear measurement. Inter-patient variability from RSA examinations is likely a source of error when dealing with such small units of measure. Further analysis on patient age and body mass index may eliminate some variability in the data to improve accuracy. Despite high standard deviations, the results from this research are in proximity to previously reported linear wear measurements 0.052mm/yr and 0.054mm/yr. Linear wear analysis will continue upon completion of >100 patients, in addition to volumetric PE wear over the entire articulating surface.


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.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 137 - 137
1 Jan 2016
Laende E Richardson G Biddulph M Dunbar M
Full Access

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.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 136 - 136
1 Jan 2016
Laende E Richardson G Biddulph M Dunbar M
Full Access

Introduction

Surgical techniques for implant alignment in total knee arthroplasty (TKA) is a expanding field as manufacturers introduce 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. The resulting planned alignment can vary greatly from a neutral mechanical axis. The purpose of this study was to evaluate the early fixation of components in subjects randomized to receive shape match derived kinematic alignment or conventional alignment using computer navigation. A subset of subjects were evaluated with gait analysis.

Methods

Fifty-one patients were randomized to receive a cruciate retaining cemented total knees (Triathlon, Stryker) using computer navigation aiming for neutral mechanical axis (standard of care) or patient-specific cutting blocks (OtisMed custom-fit blocks, Stryker). Pre-operatively, all subjects had MRI scans for cutting block construction to maintain blinding. RSA exams and health outcome questionnaires were performed post-operatively at 6 week, 3, 6, and 12 month follow-ups. A subset (9 subjects) of the patient-specific group underwent gait analysis (Optotrak TM 3020, AMTI force platforms) one-year post-TKA, capturing three dimensional (3D) knee joint angles and kinematics. Principal component analysis (PCA) was applied to the 3D gait angles and moments of the patient-specific group, a case-matched control group, and 60 previously collected asymptomatic subjects.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 138 - 138
1 Jan 2016
Laende E Dunbar M Richardson G Biddulph M
Full Access

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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 158 - 158
1 Sep 2012
Hennigar A Gross M Amirault D Laende E Dunbar MJ
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Purpose

To determine if minimally invasive surgery (MIS) for primary hip replacement surgery increases the risk of long term aseptic loosening as predicted by implant micromotion measured with radiostereometric analysis (RSA).

Method

Ninety patients undergoing primary THA for osteoarthritis (exclusion criteria: post-traumatic arthritis, rheumatoid arthritis, hip dysplasia, previous hip infection) were randomized to undergo THR surgery utilizing the standard direct lateral approach (n=45; 24 male; age=58 yrs; BMI=27) or MIS via a one-incision direct lateral approach using specific instrumentation (n=45; 23 male; age=55; BMI=29). Uncemented acetabular and femoral (ProfemurZ) components were used with ceramic on ceramic bearings. The femur was marked with 9 tantalum beads placed in the greater trochanter, lesser trochanter, and femoral shaft distal to the tip of the prosthesis. Post-operative care was be standardized according to the care maps at our institution. Primary outcome measure was femoral stem MTPM (maximum total point motion) measured using Model-based RSA. Stereo supine X-rays were taken before weight bearing and 3, 6, and 12 months postoperatively. At the same time intervals Harris Hip Score, Oxford-12, WOMAC, and SF36 questionnaires were administered. Rates of infection, dislocation and revision were recorded.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 49 - 49
1 Sep 2012
Konadu D Wilson JA Dunbar MJ Laende E Hennigar A Gross M
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Purpose

Aseptic loosening of the tibial component of total knee prosthesis is a common cause of revision surgery. While micromotion at the bone-implant interface can now be accurately measured with Radiostereometric Analysis (RSA), mechanisms responsible for loosening remain poorly understood. The purpose of this study was to investigate the association between bone density in the proximal tibia and post-operative knee implant migration.

Method

Fifty-one subjects who received total knee arthroplasty surgery with the Wright Medical Advance Biofoam (uncemented) implant were recruited. Bone density of seven regions of the proximal tibia (medial, lateral, anterior, posterior, and three regions below implant tip) was measured with DEXA post operatively at two, six, 12 and 24 weeks. RSA exams were also taken immediately post-operatively, and at six, 12 and 24 weeks. Correlations between bone mineral density and RSA migration were examined at 24 weeks post-operatively.


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.


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 148 - 149
1 Mar 2008
Dunbar M Laende E Hennigar A Amirault D Reardon G Gross M
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Purpose: The Advance Medial Pivot (MP) knee has higher congruency and postulated different kinematics than traditional posterior stabilized knee implants. This could lead to increased micromotion at the tibial component/bone interface potentially resulting in premature loosening. To investigate the stability of the MP knee we used maximum total point motion (MTPM) as determined with RSA to compare micromotion at the tibial component/bone interface between the Advance MP and PS knees.

Methods: A power calculation determined that a minimum sample size of 40 (20/group) was required. Sixty-six patients (48 females) with primary osteoarthritis of the knee were randomized to receive the Advance MP (n=36) or PS (n=30) knee. Three experienced knee surgeons followed a standardized surgical technique (PCL resection, patella resurfacing, RSA bead placement in polyethylene and tibia) and post-operative protocol (CPM as tolerated, no drains, WBAT). SF-36, WOMAC, PCS, KSCRS were administered to all patients pre-operatively and at 6, 12 and 24 months post-operatively and BMI was recorded. Within 4 days of surgery and at 6, 12 and 24 months post-operatively patients underwent bi-planar x-rays.

Results: Fifteen patients were lost to follow-up (2 infections, 1 death, 2 dropped out, 10 lost due to technical issues). There was no difference in MTPM between groups at 2 years. Physical function was better (p< 0.03) for the PS group at 6 months but there was no difference at 1 year.

Conclusions: There was no difference in MTPM between groups at 2 years post-op. The Advance PS knee appears to result in earlier post-operative improvements in physical function. The altered kinematics and increased congruency of the Advance MP knee does not seem to alter the forces at the tibial component/bone interface and therefore does not appear to be more prone to migration and premature aseptic loosening.

Funding : Other Education Grant

Funding Parties : Unrestricted grant from Wright Medical Inc.