Influence of marker-selection method in radiostereometric analysis of total knee arthroplasty on tibial baseplate migration patterns: a secondary analysis of a randomized controlled trial with 5-year follow-up.

BACKGROUND AND PURPOSE:  Different marker-selection methods are applied to represent implant and tibial segments in radiostereometric analysis (RSA) studies of total knee arthroplasty (TKA). Either a consistent set of markers throughout subsequent RSA examinations ("consistent-marker method") is used or all available markers at each follow-up ("all-marker method"). The aim of this secondary analysis was to compare marker-selection methods on individual and group level TKA migration results. METHODS:  Data from a randomized RSA study with 72 patients was included. Tibial baseplate migration was evaluated at 3 months, 1, 2, and 5 years postoperatively with both marker-selection methods. Additionally, migration was calculated using 5 fictive points, either plotted based on the consistent set of markers or all available markers. RESULTS:  Migration could be calculated with both marker-selection methods for 248 examinations. The same prosthesis and bone markers (n = 136), different prosthesis markers (n = 71), different bone markers (n = 21), or different prosthesis and bone markers (n = 20) were used. The mean difference in maximum total point motion (MTPM) between all examinations was 0.02 mm, 95% confidence interval -0.26 to 0.31 mm. 5 implants were classified as continuously migrating with the consistent-marker method versus 6 implants (same 5 plus one additional implant) with the all-marker method. Using fictive points, fewer implants were classified as continuously migrating in both marker-selection methods. Differences between TKA groups in mean MTPM were comparable with both marker-selection methods, also when fictive points were used. CONCLUSION:  Estimated group differences in mean MTPM were similar between marker-selection methods, but individual migration results differed. The latter has implications when classifying implants for estimated risk of future loosening.

A prospective randomized study of Refobacin Bone Cement R versus Palacos R + G.

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. Results: Median distal migration (y-axis) at two years for the Refobacin-Optivac system was -0.79 mm (-2.01 to -0.09), for the Refobacin-Optipac system was -0.75 mm (-2.16 to 0.20), and for the Palacos-Optivac system was -1.01 mm (-4.31 to -0.29). No statistically significant differences were found between the groups. Secondary outcomes did not differ statistically between the groups at the two-year follow-up. Conclusion: At two years, we found no significant differences in distal migration or clinical outcomes between the three groups. Our data indicate that Refobacin Bone Cement R and Palacos R + G are comparable in terms of stable fixation and early clinical outcomes.

Phantom validation of a novel RSA-based impingement metric to assess component-on-component impingement risk.

Component-on-component impingement in total hip arthroplasty may lead to post-operative complications including dislocation. Despite numerous clinical studies focusing on reducing this risk, assessment methods remain limited to qualitative radiography, finite element analysis, and cadaver studies. There is a need for more precise measurements of impingement in the research setting. We aimed to validate a novel RSA-based impingement metric to measure component-on-component impingement in vivo. A phantom experiment of a standard metal-on-polyethylene total hip system was performed. RSA examinations were performed as typical for a traditional weight-bearing RSA exam for large joints. The phantom was placed in 10 possible impinged positions and one neutral position. Double exposure radiographs were taken to measure repeatability. The closest distance between the skirt of the head and the inner circumference of the acetabular cup liner was measured to assess impingement risk. Distances between the closest point of the hood to the edge of the cup in 10 impinged positions ranged from 0.05 to 1.03 mm, with the average being 0.67 mm. In the neutral position, the distance measured is 11.02 mm. Excellent repeatability was observed, with a standard deviation of 0.03 mm with an r value of 0.09. A validated RSA-based risk metric was established to evaluate in vivo hip impingement. A 1 mm threshold may be proposed to define impingement where distances approaching 1.00 mm are at a greater risk of impingement. This simplified metric holds promise for upcoming clinical studies on component-on-component impingement.

Stable fixation of an ultra-short femoral neck-preserving hip prosthesis: a 5-year RSA, DXA, and clinical prospective outcome study of 48 patients.

BACKGROUND AND PURPOSE: We previously showed promising primary stability and preservation of bone stock with the ultra-short neck-loading hip implant in total hip arthroplasty (THA). The aim of this study was to evaluate clinical outcome, implant stability, and bone mineral density (BMD). METHODS: 50 patients were treated with the ultra-short neck Primoris hip implant at baseline and 48 were available for evaluation at 5-year follow-up. 5 different patient-reported outcome measures (PROMs) including hip-specific scores, disease-specific and generic quality of life outcome measures, and an activity score were used. Furthermore, implant stability using radiostereometric analysis (RSA) and assessment of periprosthetic BMD using dual-energy X-ray absorptiometry (DXA) were applied. RESULTS: By 1-year follow-up, all PROMs showed improvements and remained high at 5-year follow-up. After initial distal translation (subsidence) and negative rotation around the z-axis (varus tilt) the implant showed stable fixation at 5-year follow-up with no further migration beyond 12 months. In the regions of interest (ROI) 3 and 4, BMD remained stable. In ROI 2, further bone loss of 12% was found at 5-year follow-up. CONCLUSION: Clinical outcome including PROMs was satisfying throughout the 5-year follow-up period. The hip implant remains stable with both bone preservation and loss 5 years after surgery.

Risk of tibial baseplate loosening is low in patients following unrestricted kinematic alignment total knee arthroplasty using a cruciate-retaining medial conforming insert: A study using radiostereometric analysis at 2 years.

PURPOSE: Assessing the risk of tibial baseplate loosening in patients after unrestricted kinematically aligned (unKA) total knee arthroplasty (TKA) using a medially conforming insert is important because baseplates generally are aligned in varus which has been linked to an increased incidence of aseptic loosening following mechanically aligned TKA. Two limits that indicate long-term stability in patients are a change in maximum total point motion between 1 and 2 years (ΔMTPM) < 0.2 mm and anterior tilt at 2 years < 0.8°. The purposes were to determine: (1) the number of patients with ΔMTPM > 0.2 mm, (2) the number of patients with anterior tilt > 0.8° and (3) whether increased varus baseplate and limb alignment were associated with increased migration. METHODS: Thirty-five patients underwent cemented, caliper-verified, unKA TKA using a medially conforming tibial insert with posterior cruciate ligament (PCL) retention. Biplanar radiographs acquired on the day of surgery and at 1.5, 3, 6, 12 and 24 months were processed with model-based radiostereometric analysis (RSA) software to determine migration and the number of patients with migration above the two stability limits. Medial proximal tibial angle (MPTA), hip-knee-ankle angle (HKAA) and posterior slope angle (PSA) were analyzed for an association with migration in six degrees of freedom and in MTPM. RESULTS: Thirty-two of 35 patients were available for analysis at 2 years. One patient exhibited ΔMTPM > 0.2 mm. The same patient exhibited anterior tilt > 0.8°. Varus rotation (p = 0.048, r ≤ 0.34) and medial translation (p = 0.0273, r ≤ 0.29) increased with increased varus baseplate alignment. CONCLUSION: The results indicate low risk of long-term baseplate loosening in patients. Although varus rotation and medial translation increased with increased varus baseplate alignment, the magnitudes of the migrations were minimal and did not increase ΔMTPM and anterior tilt. LEVEL OF EVIDENCE: Level II, therapeutic prospective cohort study.

Migration and clinical outcomes of a novel cementless hydroxyapatite-coated titanium acetabular shell: two-year follow-up of a randomized controlled trial using radiostereometric analysis.

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.

Comparison between model-based RSA and an AI-based CT-RSA: an accuracy study of 30 patients.

BACKGROUND AND PURPOSE: Radiostereometry (RSA) is the current gold standard for evaluating early implant migration. CT-based migration analysis is a promising method, with fewer handling requirements compared with RSA and no need for implanted bone-markers. We aimed to evaluate agreement between a new artificial intelligence (AI)-based CT-RSA and model-based RSA (MBRSA) in measuring migration of cup and stem in total hip arthroplasty (THA). PATIENTS AND METHODS: 30 patients with THA for primary osteoarthritis (OA) were included. RSA examinations were performed on the first postoperative day, and at 2 weeks, 3 months, 1, 2, and 5 years after surgery. A low-dose CT scan was done at 2 weeks and 5 years. The agreement between the migration results obtained from MBRSA and AI-based CT-RSA was assessed using Bland-Altman plots. RESULTS: Stem migration (y-translation) between 2 weeks and 5 years, for the primary outcome measure, was -0.18 (95% confidence interval [CI] -0.31 to -0.05) mm with MBRSA and -0.36 (CI -0.53 to -0.19) mm with AI-based CT-RSA. Corresponding proximal migration of the cup (y-translation) was 0.06 (CI 0.02-0.09) mm and 0.02 (CI -0.01 to 0.05) mm, respectively. The mean difference for all stem and cup comparisons was within the range of MBRSA precision. The AI-based CT-RSA showed no intra- or interobserver variability. CONCLUSION: We found good agreement between the AI-based CT-RSA and MBRSA in measuring postoperative implant migration. AI-based CT-RSA ensures user independence and delivers consistent results.

Acetabular cup fixation with and without screws following primary total hip arthroplasty: migration evaluated by radiostereometric analysis.

BACKGROUND: Early cup migration after total hip arthroplasty (THA) is correlated to late revision due to aseptic loosening. However, the use of screws for increased cup stability remains unclear and debated. The purpose of this study is to assess acetabular migration between cups fixated with and without the use of screws. METHODS: Patients underwent primary THA using either a direct anterior (DA) or a direct lateral (DL) approach. The DA surgeon routinely supplemented cup fixation with 1 or 2 screws while the DL surgeon used no screws. At 7 follow-up visits up to 2 years post operation, patients underwent radiostereometric analysis (RSA) imaging for implant migration tracking. The primary outcome was defined as proximal cup migration measured with model-based RSA. RESULTS: 68 patients were assessed up to 2 years post operation, n = 43 received screws and n = 25 did not. The use of screws had a significant effect on cup migration (p = 0.018). From 2 weeks to 2 years post operation, the total mean migration was 0.403 ± 0.681 mm and 0.129 ± 0.272 mm (p = 0.319) for cups with and without screws, respectively. The number of screws used also had a significant impact, with cups fixated with 1 screw migrating more than cups fixated with 2 (p = 0.013, mean difference 0.712 mm). CONCLUSIONS: Acetabular cups fixated with only 1 screw resulted in greater migration than cups with no screws or 2 screws, though the mean magnitude was well under the 1.0 mm threshold for unacceptable migration. However, 3 of the 24 patients who received only 1 screw exceeded the 1.0 mm threshold for unacceptable migration. Ultimately, the results of this study show that the use of 2 screws to supplement cup fixation can provide good implant stability that is equivalent to a secure press-fit component with no screws.Clinical trial registration: ClinicalTrials.gov (NCT03558217).

Corroboration of coupled musculoskeletal model and finite element predictions with in vivo RSA migration of an uncemented acetabular component.

While finite element (FE) models have been used extensively in orthopedic studies, validation of their outcome metrics has been limited to comparison against ex vivo testing. The aim of this study was to validate FE model predictions of the initial cup mechanical environment against patient-matched in vivo measurements of acetabular cup migration using radiostereometric analysis (RSA). Tailored musculoskeletal and FE models were developed using a combination of three-dimensional (3D) motion capture data and clinical computerized tomography (CT) scans for a cohort of eight individuals who underwent primary total hip replacement and were prospectively enrolled in an RSA study. FE models were developed to calculate the mean modulus of cancellous bone, composite peak micromotion (CPM), composite peak strain (CPS) and percentage area of bone ingrowth. The RSA cup migration at 3 months was used to corroborate the FE output metrics. Qualitatively, all FE-predicted metrics followed a similar rank order as the in vivo RSA 3D migration data. The two cases with the lowest predicted CPM (<20 µm), lowest CPS (<0.0041), and high bone modulus (>917 MPa) were confirmed to have the lowest in vivo RSA 3D migration (<0.14 mm). The two cases with the largest predicted CPM (>80 µm), larger CPS (>0.0119) and lowest bone modulus (<472 MPa) were confirmed to have the largest in vivo RSA 3D migration (>0.78 mm). This study enabled the first corroboration between tailored musculoskeletal and FE model predictions with in vivo RSA cup migration. Investigation of additional patient-matched CT, gait, and RSA examinations may allow further development and validation of FE models.

A multimodal assessment of cementless tibial baseplate fixation using radiography, radiostereometric analysis, and magnetic resonance imaging.

Fixation in cementless total knee arthroplasty is provided by osseous integration. Radiography, radiostereometric analysis (RSA), and magnetic resonance imaging (MRI) were used simultaneously to investigate fixation. Relationships between RSA-measured implant micromotions and MRI-evaluated osseous integration at the component-bone interface were assessed in 10 patients up to 6 months postoperation. Supine MRI (using multispectral imaging sequences) and RSA exams were performed to evaluate osseous integration and measure longitudinal migration, respectively. Inducible displacement was measured from standing RSA exams. Radiolucent lines were detected on conventional radiographs. Of 10 patients, 6 had fibrous membranes detected on MRI. No fluid or osteolytic interfaces were found, and no components were scored loose. Of 10 patients, 6 had radiolucent lines detected. Average maximum total point motion (MTPM) for longitudinal migration at 6 months was 0.816 mm (range 0.344-1.462 mm). Average MTPM for inducible displacement at 6 months was 1.083 mm (range 0.553-1.780 mm). Fictive points located in fibrous-classified baseplate quadrants had greater longitudinal migration than fictive points located in baseplate quadrants with normal interfaces at 2 weeks (p = 0.031), 6 weeks (p = 0.046), and 3 months (p = 0.047), and greater inducible displacements at 3 months (p = 0.011) and 6 months (p = 0.045). Greater early micromotion may be associated with the presence of fibrous membranes at the component-bone interface. Clinical significance: This multimodal imaging study contributes knowledge of the fixation of modern cementless TKA, supporting the notion that osseous integration is important for optimal implant fixation.

Validation for the effect of intra-exposure patient motion on the assessment of radiostereometric implant migration in a tibial component phantom study.

BACKGROUND: An increasing number of radiostereometry (RSA) research studies have long-term follow-up implant migration outcomes, which show ascending curves of implant migration with occasionally decreasing migration. After scrutinizing images and RSA scenes related to the alternating curves, we suppose that intra-exposure patient motion may contribute to that. The main purposes of this in vitro study were 1) to identify whether the patient motion in different directions could result in the inaccurate assessment of implant migration, and 2) to figure out which direction(s) accounted for the alternating curves. HYPOTHESIS: It was hypothesized that the assessments of implant migration would be less precise and accurate than they could be when patient motion occurred, and such motion would contribute to the alternating curves of radiostereometric implant migration. MATERIALS AND METHODS: A customized phantom, assembled with a tibial component, was designed for simulating intra-exposure patient motion during follow-up RSA examinations. Two different Roentgen tubes were used as the current standard of radiology departments. Radiographs were acquired in a uniplanar technical arrangement. Two defined protocols were conducted: one is to simulate implant migration outcomes at post-op, the early stage (6months), and the later stage (2 to 10years) ; during the later stage, the other is to mimic patient motion by phantom motion in the medial-lateral (x), distal-proximal (y), and anterior-posterior (z) axes. RESULTS: Phantom motion could result in the inaccurate assessment of implant migration, and translations along the medial-lateral (x) axis were the most influenced by patient motion. Motion along the medial-lateral (x) axis could account for the curves with decreasing migration. DISCUSSION: Our assessments of implant migration may be less precise and accurate than they could be when intra-exposure patient motion occurs. We probably neglect the importance of 100% simultaneous exposures, and the influence of patient motion on RSA accuracy and data reliability, due to the difficulty in detecting patient (micro)motion. Electronically synchronized exposures of two paired Roentgen tubes are 100% simultaneous for image acquisition, and they are thus highly recommended for the assessment of implant migration in RSA. TYPE OF STUDY AND LEVEL OF PROOF: not applicable.

6-month migration sufficient for evaluation of total knee replacements: a systematic review and meta-analysis.

BACKGROUND AND PURPOSE: This updated meta-analysis evaluates the migration pattern of the tibial component of primary total knee replacements measured with radiostereometric analysis (RSA). We aimed to evaluate whether 6-month maximum total point motion (MTPM) values could be used instead of 1-year MTPM for RSA threshold testing and to present the pooled migration patterns for different implant designs that can be used as a benchmark. PATIENTS AND METHODS: The search included all published RSA studies on migration patterns of tibial components until 2023. Study groups were classified according to their prosthesis brand, fixation, and insert (PFI). Sub-analyses were performed to compare the mean tibial component migration patterns of different implant variables, stratified according to fixation. RESULTS: 96 studies (43 new studies), including 197 study groups and 4,706 knees, were included. Most migration occurred within the first 6 postoperative months (126 study groups: mean 0.58 mm, 95% confidence interval [CI] 0.50-0.65), followed by minimal migration between 6 and 12 months (197 study groups: mean 0.04 mm, CI 0.03-0.06), irrespective of the fixation method used. Distinct migration patterns were observed among the different fixation methods. No differences were found in migration patterns among cemented components in any of the sub-group analyses conducted. For uncemented implants, trabecular metal surfaced components seemed to migrate less than porous-coated or uncoated components Conclusion: Based on the small difference between MTPM values at 6 months and 1 year, MTPM at 6 months could be used instead of MTPM at 1 year for RSA threshold testing. The pooled migration patterns can be used as benchmark for evaluation of new implants by defining fixation-specific RSA thresholds when combined with implant survival.

Dose reduction does not impact the precision of CT-based RSA in tibial implants: a diagnostic accuracy study on precision in a porcine cadaver.

BACKGROUND AND PURPOSE: Radiostereometric analysis (RSA) is the gold standard for evaluation of migration of implants. CT-RSA has been shown to have precision at the level of RSA in hip, shoulder, and knee joint replacements. We aimed to assess the impact of dose reduction on precision of CT-RSA on tibial implants, comparing it with previously published data on precision of standard dose CT-RSA on tibial implants. MATERIAL AND METHODS: We performed a total knee arthroplasty on a porcine knee cadaver, and subsequent CT-RSA with low effective doses (0.02 mSv). We compared the results with previously published CT-RSA data with standard (0.08 mSv) dose. The primary outcome variable was the difference in precision of the maximum total translation (MTT). Secondary variables included ratios of variances and standard deviations, and precision of peripheral point translations, center-of-mass translations, and rotations. A difference of more than 0.1 mm in precision was defined as clinically relevant. Our hypothesis was that precisions of low and standard CT-RSA doses were equal. RESULTS: Low dose (mean 0.07, 95% confidence interval [CI] 0.06-0.08) and standard dose CT-RSA (0.08, CI 0.07-0.09) achieve similar precision, with difference in precision of MTT of 0.01, CI 0.00-0.02 mm. The F-statistic (0.99, CI 0.63-1.55) and sdtest (1.05, CI 0.43-2.58) also supported this. CONCLUSION: We conclude that the precision of low dose CT-RSA for tibial implants on a porcine cadaver is equal to standard dose CT-RSA. However, these findings should be confirmed in clinical trials.

A low-dose biplanar X-ray imager has RSA level precision in total knee arthroplasty.

BACKGROUND AND PURPOSE: The low radiation biplanar X-ray imager (EOS imaging, Paris, France) scans patients in a weight-bearing position, provides calibrated images, and limits radiation, an asset for serial radiostereometric analysis (RSA) studies. RSA in vivo precision values have not been published for this type of imaging system, thus the goal of this study was to assess the precision of RSA in vivo utilizing a low radiation biplanar imager. PATIENTS AND METHODS: At a mean of 5 years post-surgery (range 1.4-7.5 years), 15 total knee arthroplasty (TKA) participants (mean age 67 years at the time of imaging, 12 female, 3 male) with RSA markers implanted during index surgery were scanned twice at the same visit in the EOS imager. Precision of marker-based analysis was calculated by comparing the position of the implant relative to the underlying bone between the 2 examinations. RESULTS: The 95% limit of precision was 0.11, 0.04, and 0.15 mm along the x, y, and z axes, respectively and 0.15°, 0.20°, and 0.14° around the same axes. CONCLUSION: This precision study has shown an in vivo RSA precision of ≤ 0.15 mm and ≤ 0.20°, well within published uniplanar values for conventional arthroplasty RSA, with the added benefit of weight-bearing imaging, a lower radiation dose, and without the need for a reference object during the scan.

Comparison of two hydroxyapatite-coated femoral components: a randomized clinical trial using radiostereometric analysis.

Aims: The primary aim of this trial was to compare the subsidence of two similar hydroxyapatite-coated titanium femoral components from different manufacturers. Secondary aims were to compare rotational migration (anteversion/retroversion and varus/valgus tilt) and patient-reported outcome measures between both femoral components. Methods: Patients were randomized to receive one of the two femoral components (Avenir or Corail) during their primary total hip arthroplasty between August 2018 and September 2020. Radiostereometric analysis examinations at six, 12, and 24 months were used to assess the migration of each implanted femoral component compared to a baseline assessment. Patient-reported outcome measures were also recorded for these same timepoints. Overall, 50 patients were enrolled (62% male (n = 31), with a mean age of 65.7 years (SD 7.3), and mean BMI of 30.2 kg/m2 (SD 5.2)). Results: The two-year subsidence was similar for Avenir (-0.018 mm (95% confidence interval (CI) -0.053 to 0.018) and Corail (0.000 mm (95% CI -0.027 to 0.026; p = 0.428). Both anteversion/retroversion (Avenir 0.139° (95% CI -0.204 to 0.481°); Corail -0.196° (95% CI -0.445 to 0.053°; p = 0.110) and varus/valgus tilt (Avenir -0.024° (95% CI -0.077 to 0.028); Corail -0.049° (95% CI -0.098 to 0.000°; p = 0.473) were not statistically significantly different. After two years, patients reported similar improvements in EuroQol five-dimension five-level health questionnaire (Avenir 0.22 (SD 0.2); Corail 0.22 (SD 0.18); p = 0.965) and other outcomes scores. Patient satisfaction on a five-point Likert scale was also similar between both groups after two years (Avenir 1.38 (SD 0.88); Corail 1.33 (SD 0.57); p = 0.846). Conclusion: The performance of both femoral components was similar in terms of stability and patient outcomes.

State of the Art in Radiostereometric Analysis for Tibial Baseplate Migration and Future Research Directions.

Radiostereometric analysis (RSA) measures movement (migration) of a baseplate relative to the underlying tibia after total knee arthroplasty (TKA) and has been used extensively to evaluate safety of new implant designs and/or surgical techniques regarding baseplate loosening. Because RSA is a complex methodology which involves various choices that researchers make, including whether to use marker-based or model-based methods, which migration metric to report, how to relate short-term migrations to long-term risk, and how these choices impact error, the objectives of this review were to: (1) lay out a comprehensive structure illustrating the multiple components/considerations for RSA and their interrelations, (2) review components of the structure using the latest RSA literature, and (3) use the preceding review as a context for identifying future areas of study. The components to be reviewed were structured using the following topics: type of RSA, migration metrics, sources of error, studies/reports of error, stability limits, and studies of error in stability limits. Based on the current RSA literature and knowledge gaps which exist, the following future research directions were identified: (1) revising the ISO standard to require reporting of clinical measurement error (bias) and recommending use of a local baseplate coordinate system, (2) identifying the migration metric and associated threshold most predictive of baseplate loosening for individual patients, (3) creating a method for data sharing to improve individual patient diagnostics, and (4) determining an appropriate stability limit for model-based RSA for group stability and individual patient diagnostics.

No difference in component migration at five years between the cemented cruciate-retaining ATTUNE and PFC-Sigma knee prosthesis: an update of a randomized clinical radiostereometry trial.

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.

No effect of hydroxyapatite-coated sliding hip screw threads on screw migration in the femoral head/neck of pertrochanteric fractures: a randomized controlled trial using radiostereometric analysis.

INTRODUCTION: Cut-out is the most frequently reported mechanical failure of internal fixation of pertrochanteric fractures. The purpose of this study was to examine if hydroxyapatite-coated screw thread on a sliding hip screw (SHS) could reduce screw migration within the femoral head in patients with stable pertrochanteric fractures. MATERIALS AND METHODS: In a double-blinded randomized controlled study, 37 patients at mean age 78 (range 56-96), with pertrochanteric fracture (Evans I, II, IV) received surgery with a SHS with a hydroxyapatite-coated or a non-coated lag screw thread. Radiostereometry and standard radiographs were obtained 1 day, 6 weeks, 3- and 6 months post-operatively to evaluate screw and fracture migration and fracture reposition. The two groups were combined to describe fracture migration. RESULTS: There was similar and small screw migration in the femoral head between the two groups at 6 weeks, 3- and 6 months (p > 0.12). Fracture migration occurred predominantly in the first 6 weeks, where fracture impaction was 5.95 mm (CI 95% 2.87 to 9.04) and anterior rotation of the femoral head was -2.94° (CI 95% - 5.22 to - 0.66). Migration of the fracture (total translation) correlated to the post-operative fracture reposition (p = 0.002), but not significantly to screw migration (p = 0.09). Neither screw total translation (rho 0.06, p = 0.79) nor fracture total translation (rho 0.04, p = 0.77) correlated with bone mineral density. CONCLUSION: There was no clinical benefit of hydroxyapatite coating on lag screw migration in this patient cohort. Migration of the pertrochanteric fractures was higher with poor fracture reposition but fractures generally stabilized after 6 weeks follow-up. The study was registered at ClinicalTrials.gov (NCT05677061). LEVEL OF EVIDENCE II: Patient-blinded prospective randomized study. Trial registration number The study was registered at ClinicalTrials.gov (NCT05677061).

Surgical approach had minor association with femoral stem migration in total hip arthroplasty: radiostereometric analysis of 61 patients after 5-year follow-up.

BACKGROUND AND PURPOSE: Total hip arthroplasty (THA) is usually performed using 1 of 3 surgical approaches: direct lateral (DLA), posterior (PA), or anterior (AA). AA is different from DLA and PA owing to limited intraoperative visibility of the femoral canal. This could affect stem positioning and therefore migration. We aimed to perform an exploratory radiostereometric analysis (RSA) study with 3 groups for surgical approach assessing stem migration up to 5 years postoperatively. PATIENTS AND METHODS: 61 patients with unilateral osteoarthritis of the hip were included. 21 patients were allocated to the DLA, 20 to the PA, and 20 to the AA group. All patients received an uncemented, collarless, double-tapered, fully hydroxyapatite-coated Profemur Gladiator stem. Migration was measured with model-based RSA. Baseline RSA was on day 1 postoperatively. The follow-ups were at day 8, at 5 weeks, and at 3, 6, 12, 24, and 60 months after surgery. Generalized linear mixed models were used to analyze maximum total point motion (MTPM) migrations. RESULTS: Group mean differences in MTPM were 0.4 mm (95% confidence interval [CI] -1.5 to 2.4) for DLA vs. PA, 1.1 mm (CI -1.0 to 3.3) for AA vs. DLA, and 1.6 mm (CI -0.8 to 3.9) for AA vs. PA, when adjusted for sex and age as covariates. 2 stems in the AA group had excessive early migration. For all stems the migrations occurred mainly within 5-week follow-up and then stabilized. CONCLUSION: At 5-year follow-up, there were no statistically significant differences in stem migration associated with the 3 surgical approaches used in this study.

Wider translations and rotations in posterior-stabilised mobile-bearing total knee arthroplasty compared to fixed-bearing both implanted with mechanical alignment: a dynamic RSA study.

PURPOSE: The purpose of this study was to investigate the in vivo kinematics of the same femoral design mechanically aligned posterior-stabilised (PS) total knee arthroplasty (TKA) with either fixed-bearing (FB) or mobile-bearing (MB) inlay, implanted by the same surgeon, using model-based dynamic radiostereometric analysis (RSA). The hypothesis of the present study was that the MB design would show wider axial rotation than the FB design, without affecting the clinical outcomes. MATERIALS AND METHODS: A cohort of 21 non-randomised patients (21 DePuy Attune PS-FB) was evaluated by dynamic RSA analysis at a minimum 9-month follow-up, while performing differently demanding daily living activities such as sit to stand (STS) and deep knee lunge (DKL). Kinematic data were compared with those of a cohort of 22 patients implanted with the same prosthetic design but with MB inlay. Anterior-posterior (AP) translations, varus-valgus (VV) and internal-external (IE) rotations of the femoral component with respect to the tibial baseplate were investigated. Translation of medial and lateral compartment was analysed using the low point method according to Freeman et al. Questionnaires to calculate objective and subjective clinical scores were administered preoperatively and during follow-up visit by the same investigator. RESULTS: The FB TKA design showed lower AP translation during STS (6.8 ± 3.3 mm in FB vs 9.9 ± 3.7 mm in MB, p = 0.006*), lower VV rotation (1.9 ± 0.8° in FB vs 5.3 ± 3.3° in MB, p = 0.005) and lower IE rotation (2.8 ± 1.1° in FB vs 9.5 ± 4.3° in MB, p = 0.001) during DKL than the mobile-bearing TKA design. Posterior-stabilised FB group showed significant lower translation of the low point of the medial compartment than the MB group (p = 0.008). The percentage of patients performing medial pivot in the FB group was higher compared to MB group in the examined motor tasks. No significant differences in post-operative range of motion (117° ± 16° for FB group and 124° ± 13° for MB group) and in clinical outcomes emerged between the two cohort. CONCLUSIONS: The FB and MB designs differed in AP translations, VV rotations and IE rotations of the femoral component with respect to the tibial component in STS and DKL. Furthermore, FB cohort reported a significant higher percentage of medial pivot with respect to MB cohort. Despite this, no differences in clinical outcomes were detected between groups. Both designs showed stable kinematics and represent a viable option in primary TKA. LEVEL OF EVIDENCE: Prospective cohort study, II.