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

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

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 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

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

Background. Patient specific instrumentation (PSI) for total knee replacement (TKR) has demonstrated mixed success in simplifying the operation, reducing its costs, and improving limb alignment. Evaluation of PSI with tools such as radiostereometric analysis (RSA) has been limited, especially for cut-through style guides providing mechanical alignment. The primary goal of the present study was to compare implant migration following TKR using conventional and PSI surgical techniques, with secondary goals to examine whether the use of PSI reduces operative time, instrumentation, and surgical waste. Methods. The study was designed as a prospective, randomized controlled trial of 50 patients, with 25 patients each in the PSI and conventional groups, powered for the RSA analysis. 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 alignment. All patients received the same posterior-stabilized implant, with marker beads inserted in the bone around the implants to enable RSA imaging. Intraoperative variables such as time, number of instrumentation trays used, and mass of surgical waste were recorded. Patients underwent supine RSA exams at multiple time points (2&6 weeks, 3&6 months and yearly) with 6 months data currently available. Migration of the tibial and femoral components was calculated using model-based RSA software. WOMAC, SF-12, EQ5D, and UCLA outcome measures were recorded pre-operatively and post-operatively. Results. There were no demographic differences between groups. One patient in the PSI group was revised for infection, and three patients required manipulation, with no revisions or manipulations in the conventional group. There was no difference in maximum total point motion between groups for the tibia (mean 0.50 vs. 0.50 mm, p = 0.98) or femur (mean 0.46 vs. 0.48 mm, p = 0.87). The PSI group displayed greater tibial posterior tilt (p = 0.048, Fig. 1) and greater femoral anterior tilt (p = 0.01) and valgus rotation (p = 0.04, Fig. 2) than the conventional group, but there were no other differences in migrations. The PSI group required less instrument trays than the conventional group (mean 4.8 vs. 8.1 trays, p < 0.0001), but procedure time was equivalent (mean 79 vs. 74 min, p = 0.06). The PSI group produced less recyclable waste (mean 0.3 vs. 1.4 kg, p < 0.001), but total waste (Fig. 3) was equivalent between groups (mean 10.1 vs. 10.6 kg, p = 0.32). At 6 months there was no difference between groups for SF-12, WOMAC, EQ5D, or UCLA scores. Discussion. At early RSA follow-up, the two groups were broadly similar in implant fixation except for small rotational changes in the tibial and femoral components. The PSI group provided minimal or no advantage over the conventional group for operative time, instrumentation used, or surgical waste produced. The observed increase in manipulations in the PSI group is concerning, and requires additional investigation. Further radiographic and economic analysis is underway to determine if there is any benefit to the use of PSI for TKR during the perioperative and early follow-up period. For any figures or tables, please contact authors directly (see Info & Metrics tab above).

Purpose. The purpose of this study was to assess the clinical outcomes over two years for total ankle arthroplasty (TAA) using Short Form-36, Foot Function Index and Ankle Osteoarthritis Scores, and to compare these with radiostereometric analysis longitudinal migration and inducible displacement results. Method. Twenty patients undergoing TAA implanting the Mobility Total Ankle System (DePuy, Warsaw IN) were assessed at 3mth, 6mth, 1yr and 2yr followup periods by model-based radiostereometric analysis, MBRSA 3.2 (Medis specials, Leiden, The Netherlands), for longitudinal migration (LM) and inducible displacement (ID). The same subjects completed clinical outcome questionnaires at these followup periods for Short Form-36 (SF-36; Physical Component Scores (PCS) and Mental Component Scores (MCS)), Foot Function Index (FFI) and Ankle Osteoarthritis Scores (AOS). Descriptive statistics and Pearson correlations (alpha = 0.05) were calculated using Minitab 15 (Minitab Inc., State College PA). Results. For the PCS of SF-36, FFI and AOS the scores were significantly different at 2 year followup when compared to preoperative values; p = 0.005, 0.0002 and 0.0003 respectively. The PCS on average increased with respect to pre-operative by 10 points (SD = +/−13), while the MCS on average did not change with respect to pre-operative (SD = +/− 12). The FFI on average decreased by 25 points with respect to pre-operative (SD = +/− 18) and AOS on average decreased by 23 points with respect to pre-operative (SD = +/− 21). There were several correlations for the 2 yr results: AOS to FFI of r = 0.92 (p = 0.000); AOS to PCS of r = −0.67 (p = 0.005); AOS to MCS of r = −0.51 (p = 0.046); AOS to talar component ID of r = 0.70 (p = 0.004); AOS to the talar component LM of r = 0.62 (p = 0.046). PCS related better than MCS to both AOS and FFI. The LM of the talar component and tibial component were not significantly correlated, r = 0.18 (p = 0.62). The ID of the talar component and tibial component were not significantly correlated, r = 0.48 (p = 0.07). The latter result may be too underpowered to determine a significant difference; due to the small sample size. Conclusion. The outcome scores of AOS, FFI, SF-36 (PCS) and SF-36 (MCS) were correlated to each other. The strongest outcome score relationships were AOS to FFI, followed by AOS to SF-36 (PCS). The correlation of AOS to the talar component LM and ID suggests that the implant performance may be related to the stability of the talar component

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

This study used model-based radiostereometric analysis (MBRSA) to compare migration of a recently introduced cementless hip stem to an established hip stem of similar design. Novel design features of the newer hip stem included a greater thickness of hydroxyapatite coating and a blended compaction extraction femoral broach.

Fifty-seven patients requiring primary total hip arthroplasty (THA) were enrolled at a single centre. Patients were randomized to receive either an Avenir collarless stem and Trilogy IT cup (ZimmerBiomet) or a Corail collarless stem and Pinnacle cup (DePuy Synthes) via a posterior or lateral approach. Both stems are broach-only femoral bone preparation. RSA beads (Halifax Biomedical) were inserted into the proximal femur during surgery. Patients underwent supine RSA imaging a 6 weeks (baseline), 6, 12, and 24 months following surgery. The primary study outcome was total subsidence of the hip stem from baseline to 24 months as well as progression of subsidence between 12 and 24 months. These values were compared against published migration thresholds for well-performing hip stems (0.5mm). The detection limit, or precision, of MBRSA was calculated based on duplicate examinations taken at baseline. Patient reported outcome measures were collected throughout the study and included the Oxford-12 Hip Score (OHS), EuroQoL EQ-5D-5L, Hip Osteoarthritis Score (HOOS) as well as visual analogue scales (VAS) for thigh pain and satisfaction. Analysis comprised of paired and unpaired t-tests with significance set at p≤0.05.

Forty-eight patients (30 males) were included for analysis; 7 patients received a non-study hip stem intra-operatively, 1 patient suffered a traumatic dislocation within three weeks of surgery, and 1 patient died within 12 months post-surgery. RSA data was obtained for 45 patients as three patients did not receive RSA beads intra-operatively. Our patient cohort had a mean age of 65.9 years (±;7.2) at the time of surgery and body mass index of 30.5 kg/m2 (±;5.2). No statistical difference in total stem migration was found between the Avenir and Corail stems at 12 months (p=0.045, 95%CI: −0.046 to 0.088) and 24 months (p=0.936, 95% CI: −0.098 to 0.090). Progression of subsidence from 12-24 months was 0.011mm and 0.034mm for the Avenir and Corail groups which were not statistically different (p=0.163, 95%CI: −0.100 to 0.008) between groups and significantly less than the 0.5mm threshold (pNo statistically significant differences existed between study groups for any pre-operative function scores (p>0.05). All patients showed significant functional improvement from pre- to post-surgery and no outcome measures were different between study groups with exception of EQ-5D-5L health visual analogue scale at 12 months which showed marginally superior (p=0.036) scores in the Avenir group. This study was not powered to detect differences in clinical outcomes.

This study has demonstrated no statistical difference in subsidence or patient-reported outcomes between the Corail hip stem and the more recently introduced Avenir hip stem. This result is predictable as both stems are of a triple-tapered design, are coated with hydroxyapatite, and utilize a broach-only bone preparation technique. Both stem designs demonstrate migration below 0.5mm suggesting both are low-risk for aseptic loosening in the long-term.

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

Background. Radiostereometric Analysis (RSA) is an accurate measure of implant migration following total joint replacement surgery. Early implant migration predicts later loosening and implant failure, with RSA a proven short-term predictor of long-term survivorship. The proximal migration of an acetabular cup has been demonstrated to be a surrogate measure of component loosening and the associated risk of revision. RSA was used to assess migration of the R3 acetabular component which utilises an enhanced porous ingrowth surface. Migration of the R3 acetabular component was also assessed when comparing the fixation technique of the femoral stems implanted. Methods. Twenty patients undergoing primary total hip arthroplasty were implanted with the R3 acetabular cup. The median age was 70 years (range, 53–87 years). During surgery tantalum markers were inserted into the acetabulum and the outer rim of the polyliner. RSA examinations were performed postoperatively at 4 to 5 days, 6, 12 and 24 months. Data was analysed for fourteen patients to determine the migration of the acetabular cup relative to the acetabulum. Of these fourteen patients, six were implanted with a cementless femoral stem and eight with a cemented femoral stem. Patients were clinically assessed using the Harris Hip Score (HHS) and Hip Disability and Osteoarthritis Outcome Score (HOOS) preoperatively and at 6, 12 and 24 months postoperatively. Results. RSA revealed no significant acetabular cup migration in all planes of translation and rotation with mean translations below 0.40 mm and mean rotations below 1 deg at 24 months. The data suggests that acetabular migration occurred primarily in the first 6 months postoperatively. We observed mean translations at 24 months of 0.36 mm (x-axis), 0.39 mm (y-axis) and 0.35 mm (z-axis). Mean rotations of 0.68 deg (x-axis), 0.99 deg (y-axis) and 0.77 deg (z-axis) were also observed at 24 months. Micromotion along the proximal-distal translation (y-axis) plane represented proximal migration of the acetabular component (Figure 1). On investigation of the femoral stems (cementless and cemented) implanted with the R3 acetabular cup, the mean proximal migration of the acetabular cup for both was 0.39 mm (CI 0.19–0.58). For cementless femoral stems a mean proximal migration of 0.45 mm (CI 0.09–0.98) and for cemented femoral stems a mean proximal migration of 0.35 mm (CI 0.24–0.45) were observed (Figure 1). A significant difference in the clinical assessment of patients when comparing pre-operative with 6, 12 and 24 months were also observed (p < 0.0001). All clinical assessments demonstrated equivalent results when comparing the post-operative follow-up time points and the R3 acetabular cup and stem combinations. Conclusions. Mean translations and rotations were higher than previously reported for acetabular components with the enhanced porous ingrowth surface. The magnitude of proximal migration 24 months postoperatively was within published ‘acceptable’ levels, albeit within the ‘at risk’ range of 0.2–1.0 mm. Comparison of the proximal migration for cementless and cemented femoral stems expressed similar outcomes, a trend also observed with the clinical assessments. These findings support further investigation and analysis of the R3 acetabular component

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

Aims. Interest in soft tissue Radiostereometric Analysis (RSA) is rising. Previous authors have tried, with varying levels of success, to use this technique to analyse the intra-substance portion of anterior cruciate ligament (ACL) graft constructs. These methods were either prone to large amounts of marker migration, deemed unsuitable for in-vivo use or, where alternative markers such as stainless steel sutures were used, lost the inherent accuracy that made RSA an attractive tool in the first place. We describe a modification of tantalum marker balls that allows for a new method of secure fixation to soft tissue in order to accurately analyse stretch, displacement and, potentially, dynamic movement using RSA. Methods. 1.5 mm tantalum tendon markers were predrilled with 0.3 mm holes, allowing them to be sutured directly to soft tissue. Using a previously described ACL graft model, the amount of marker ball migration was then analysed using RSA after cyclical loading between 20 N and 170 N at 25 Hz for 225,000 cycles. Results. None of 40 balls loosened or became detached from the tendon grafts after 225,000 cycles. Mean migration of the tendon attached marker balls was < 0.1 mm. The maximum imprecision in determining the distance between two markers as assessed by intra- and inter-observer variability was 0.082 mm. Analysis of elastic stretch, plastic stretch, stiffness and localisation of stretch within the graft model was possible due to the low migration levels. Conclusions. This method of attachment of marker beads to soft tissue is simple, reliable and mechanically sound. This technique could potentially be used not only for the post-operative assessment of ACL reconstruction, but in all areas where soft tissue RSA is of interest

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

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

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

Purpose. To compare Radiostereometric Analysis (RSA) and subjective outcomes of Total Knee Arthroplasty (TKA) and Total Ankle Arthroplasty (TAA). Method. Twenty-five patients were recruited to receive TKA (Zimmer, NexGen LPS Trabecular Metal Monoblock) and 20 patients were recruited to receive TAA (DePuy, Mobility). The tibial component of the TKA and the tibial component of the TAA were followed for two years with RSA with exams postoperatively at six, 12 and 24 months. At two years, inducible displacement RSA at the knee and ankle was also performed. RSA outcomes measured were translations in the anterior-posterior, medial-lateral and distal-proximal directions of both implants. SF-36 outcome questionnaires were completed preoperatively and at each RSA follow-up with the outcome being the mental component score (MCS) and physical component score (PCS). Analysis of variance statistical testing was used to compare RSA outcomes and subjective outcomes. Results. Preoperatively there were no differences in age, BMI, SF-36 MCS or SF-36 PCS between the TKA and TAA patients. At six, 12 and 24 months the TKA group had significantly higher SF-36 PCS scores (p=0.006, p=0.002 and p=0.004 respectively. There were no differences at any time point in SF-36 MCS. Longitudinal RSA results showed that the TAA tibial component moved further into the bone at all follow-ups (p=0.000 at all time points). The TAA also migrated more anteriorly compared with the TKA, although this only became significant at 12 and 24 months (p=0.013, p=0.05). RSA inducible displacement showed that the TAA had greater inducible displacement into the bone than the TKA (p=0.015). Conclusion. The subjective data show that TAA and TKA both improve the symptoms of patients. However, the subjective results of the TAA have not achieved the high standard set by TKA. The RSA data suggest that the TAA is stabilizing within the bone. However, the higher longitudinal migrations and inducible displacements seen in the TAA suggest that the interface may not be as robust as in the TKA. This may partially be explained by the much smaller surface area available to distribute the loads at the ankle resulting in higher stresses and migrations. The 3rd generation of TAA has recently been reintroduced as a treatment option for severe arthritis of the ankle. Previous generations of TAA have been unsuccessful with high failure rates. It is unclear if the current generation of TAA will be more successful in the long term. Comparisons between these arthroplasty procedures with high precision measures such as RSA can provide insight into whether TAA has achieved the same level of success as TKA. Although there are no comparable migration thresholds for TAA as TKA, this study suggests that TAA may not achieve as robust an interface with the bone as TKA. The results of the current generation of TAA are promising. However, TAA still has room for improvement to achieve the same outstanding results as TKA

The direction of penetration of the femoral head following total hip replacement has been shown at revision to be superomedial, superior or superolateral. However, it is important to study well functioning components to describe normal patterns of wear. The aim of this study was to characterise the 3D direction of penetration in standard and HXLPE. A prospective double blind randomised control trial was conducted using Radiostereometric Analysis (RSA). Fifty-four subjects were randomised to receive hip replacements with either UHMWPE liners or HXLPE liners. All subjects received a cemented CPT stem and uncemented Trilogy acetabular component (Zimmer, Warsaw, IN, USA). The 3D penetration of the head into the socket was determined to a minimum of 7 years. The direction of penetration between one and seven years was in a superior and lateral direction for both groups. In the HXLPE group there was no significant penetration in the coronal or sagittal planes (superiorly 0.009 mm/yr, 95% confidence interval, ±0.045, p1 = 0.68, laterally 0.003mm/yr, CI 0.031, p1 = 0.85). In the UHMWPE group there was significant penetration 0.059 mm/yr superiorly (CI 0.042, p1 = 0.01) and 0.049 mm/yr laterally (CI 0.044, p1 = 0.03). The anterior-posterior steady state penetration was not significant in either group (HXLPE p1 = 0.39, UHMWPE p1 = 0.37). We have previously demonstrated that the penetration in the first year is creep-dominated and is in the proximal direction. From one year onwards the superolateral direction of penetration is probably due to wear. The steady-state wear direction is the same in both bearings types. It is likely that creep occurs in the direction of the Joint Reaction Force i.e. superomedial, whereas wear is perpendicular to the axis of rotation and therefore superolateral. This work may enable us to develop more accurate models for predicting wear in total hip arthroplasty

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

Introduction. Radiostereometric Analysis (RSA) is an imaging method that is increasingly being utilized for monitoring fixation of orthopaedic implants in randomized clinical trials. Extensive RSA research has been conducted over the last 35+ years using standard clinical x-ray acquisition modalities that irradiate screen/film media or Computed Radiography (CR) plates. The precision of RSA can depend on a number of factors including modality image quality. Objective. This study assesses the precision of RSA with a novel Digital Radiography (DR) system compared to a CR imaging system using different imaging techniques. Additionally, the study assesses the precision of locating beads embedded in a modified spine pedicle screw. Methods. A modified titanium spinal pedicle screw 4.5 mm diameter, 35 mm length, marked with two 1.0 mm tantalum beads, one inside the head and one near the screw tip was inserted into a bovine tibia segment. Six additional 1.0 mm tantalum beads were inserted into the bone segment superiorly, distally and adjacent to the pedicle screw. The phantom was placed on a standard clinical diagnostic imaging bed above a custom RSA carbon fiber calibration cage (Halifax Biomedical Inc.). A pair of DR or CR imaging plates were placed below the calibration cage and irradiated 8 times at 100, 125 kV at 2.5 mAs. For DR additional test were performed at 150 kV, and again at 100 kV at 0.5 mAs. At the time of abstract submission CR results at these settings were not available. To determine precision, the standard deviation of 3D vector distances between beads was determined using RSA for each of the different imaging parameters. Results. Standard deviations of the inter-bead distances measured in the pedicle screw were 44.4 and 32.1 μm (N=8) respectively for the 100 and 125 kV settings at 2.5 mAs using the DR system, compared to 109.0, 55.8 μm for CR [Fig. 1]. The distances between the bone implanted beads provided standard deviations of 24.4 and 22.7 μm respectively for the 100 and 125 kV settings at 2.5 mAs using the DR system, compared to 33.1 and 33.0 μm with the CR system. Further increasing the photon energy to 150 kV with the DR system reduces the precision error to 22.4 μm in the pedicle screw and remains approximately the same at 21.0 μm in bone. Lowering the mAs while maintaining 100 kV increases the precision error in the pedicle screw (64 μm) and showed no significant difference in bone (24.4 μm). Conclusion. The current phantom design is basic in nature and does not account for any soft tissue scatter. However, initial results indicate a considerable reduction in precision error when using DR compared to CR imaging equipment for RSA analysis. Increasing the kV did not significantly influence the precision in measuring bead locations in bone. For embedded tantalum beads within a titanium pedicle screw, imaging at higher kV values with the described DR imaging system did allow more precise localization. This approach may be useful in assessing the in vivo position of spine or other titanium implants