Late stabilization after initial migration in patients undergoing cemented total knee arthroplasty: a 5-year followup of 2 randomized controlled trials using radiostereometric analysis.

BACKGROUND AND PURPOSE: In total knee arthroplasty (TKA), metal-backed (MBT) and all-polyethylene (APT) designs have shown comparable implant migration up to 2 years postoperatively using radiostereometric analysis (RSA). However, studies comparing mid-term migration of both designs are lacking. Furthermore, continuously migrating TKAs up to 2 years may continue to migrate or stabilize thereafter. Therefore, we compared 5-year migration of MBT and APT using either cruciate-stabilizing (CS) or posteriorstabilizing (PS) designs and specifically assessed migration profiles of continuously migrating TKAs beyond 2 years. PATIENTS AND METHODS: The present study includes results from 2 randomized trials comparing migration of cemented MBT with APT of either CS (CS study, n = 59) or PS (PS study, n = 56) design. 2 surgeons performed all surgeries. We used a linear mixed model for the analyses. RESULTS: The overall migration between MBT and APT TKAs was similar for either the CS or PS design over a 5-year period. In both studies combined, 9 implants showed continuous migration in the second postoperative year, of which 1 (APT-CS) was revised for instability, 4 (2 MBT-CS, MBT-PS, APT-PS) stabilized, and 4 (2 MBT-CS, APT-CS, MBT-PS) lacked 5-year data. INTERPRETATION: Overall migration was similar between MBT and APT TKAs up to 5 years, for both the CS and PS design. 4 initially migrating TKAs stabilized between 2- and 5-year follow-up, stressing the need for longer-term followup to determine whether second-year continuous migration correctly predicts loosening.

The Influence of Postoperative Coronal Alignment on Tibial Migration After Total Knee Arthroplasty in Preoperative Varus and Valgus Knees: A Secondary Analysis of 10 Randomized Controlled Trials Using Radiostereometric Analysis.

BACKGROUND: Orthopaedic surgeons aim for mechanical alignment when performing total knee arthroplasty (TKA) as malalignment is associated with loosening. Loosening may be predicted by migration as measured with radiostereometric analysis (RSA), but previous RSA studies on postoperative alignment have shown contradictory results and have been limited to cemented implants and small numbers of patients. Therefore, we performed a secondary analysis of 10 previously published randomized controlled trials (RCTs) to compare migration between postoperative in-range and out-of-range cemented and uncemented TKA implants among patients with a preoperative varus or valgus knee. METHODS: All RCTs involving the use of RSA that had been conducted at 2 centers were included. Alignment was classified, with use of the hip-knee-ankle angle (HKA), as in-range (0° ± 3°) or out-of-range (<-3° or >3°). The fixation methods included cemented, uncemented-coated, and uncemented-uncoated. Migration was measured at 3, 12, and 24 months. A linear mixed model was used, with adjustment for fixation method and clustering of patients within centers. RESULTS: Of 476 TKA implants that had been out-of-range preoperatively, 290 were in-range postoperatively and 186 were out-of-range in either varus (n = 143) or valgus (n = 43) postoperatively. The mean migration at 3, 12, and 24 months was 0.73 mm (95% confidence interval [CI], 0.66 to 0.79 mm), 0.92 mm (95% CI, 0.85 to 1.00 mm), and 0.97 mm (95% CI, 0.90 to 1.05 mm), respectively, for the in-range group and 0.80 mm (95% CI, 0.72 to 0.87 mm), 0.98 (95% CI, 0.90 to 1.07 mm), and 1.04 mm (95% CI, 0.95 to 1.13 mm), respectively, for the out-of-range group (p = 0.07). The fixation method significantly influenced migration, with uncemented-uncoated implants migrating more than cemented and uncemented-coated implants (p < 0.001). CONCLUSIONS: Postoperative alignment did not influence migration of TKAs in the first 2 postoperative years in patients with preoperative varus or valgus alignment of the knee. However, the fixation method significantly influenced migration, with uncemented-uncoated implants showing the greatest migration. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Risk Factors for Tibial Component Loosening: A Meta-Analysis of Long-Term Follow-up Radiostereometric Analysis Data.

BACKGROUND: Radiostereometric analysis (RSA) is a highly accurate tool to detect implant migration and predict loosening following total knee arthroplasty (TKA). However, little is known about the predisposing risk factors for implant migration, nor which migration profile should be considered physiological (i.e., merely part of an implant-settling phase) and which should be considered pathological (i.e., having a high probability for implant loosening). By pooling individual participant data from long-term follow-up RSA studies, we aimed to identify predisposing risk factors for tibial component loosening. METHODS: Individual data were collected for 630 patients from 11 RSA studies. The repeated measurements were analyzed with use of a linear mixed-effects model, determining the effect of age, sex, body mass index, diagnosis, preoperative and postoperative limb alignment, and prosthesis characteristics on tibial component migration over time, taking into account the clustering of patients within studies. RESULTS: High initial migration was found to result in early mechanical loosening in 18 cases (2.9%) and septic loosening in 2 cases (0.3%), whereas stabilization of high initial migration occurred in 17 cases (2.7%). Late loosening occurred in 13 cases (2.1%). All other 580 cases (92.1%) showed early stabilization and remained stable over time. Mixed-effects model analyses showed that for cemented prostheses, sex, diagnosis, and posterior cruciate ligament type had an effect on migration, but these differences were nonsignificant when analyzing migration from 3 months onwards. Uncemented prostheses aligned in varus showed more migration than neutrally and valgus-aligned TKAs (p = 0.031), and this difference increased over time (p < 0.001). Significantly higher migration was observed following uncemented TKA without an osseointegration-promoting surface (p < 0.001). CONCLUSIONS: For cemented prostheses, increased migration during the first 3 postoperative months was observed for female patients, patients with rheumatoid arthritis, and patients who underwent a posterior-stabilized TKA. For uncemented prostheses, both postoperative varus alignment of the lower limb and the absence of an osseointegration-promoting surface significantly increased postoperative tibial component migration. LEVEL OF EVIDENCE: Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Migration of a novel 3D-printed cementless versus a cemented total knee arthroplasty: two-year results of a randomized controlled trial using radiostereometric analysis.

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

The Effect of Coronal Alignment on Tibial Component Migration Following Total Knee Arthroplasty: A Cohort Study with Long-Term Radiostereometric Analysis Results.

BACKGROUND: Recent short-term studies of total knee arthroplasty (TKA) have claimed improved clinical outcomes and implant survival when aiming to restore constitutional joint kinematics, as compared with neutral mechanical axis alignment. However, implant durability may be compromised when aligned in varus or valgus. With use of data pooled from 3 long-term radiostereometric analysis (RSA) studies, the aim of the present study was to assess the effects of coronal alignment on tibial component migration. METHODS: Coronal alignment parameters from full-leg radiographs were measured and the constitutional leg alignment was determined for each patient. We evaluated the effect of the postoperative hip-knee-ankle angle, relative to both the mechanical axis and the constitutional alignment, on tibial component migration. In-range knees were defined as within ±3° of either the neutral mechanical axis or constitutional alignment of the patient. Analysis was performed with a linear mixed-effects model, corrected for study, age, sex, preoperative alignment, diagnosis, and body mass index. RESULTS: A total of 85 cemented TKAs were included, of which 3 were revised for aseptic loosening and another 4 were considered loose. The median follow-up was 11 years. No loose tibial components were observed in mechanically in-range knees, whereas all loose tibial components were out of range. Mechanically varus knees showed the highest mean migration (maximum total point motion) of 1.55 mm (95% confidence interval [CI], 1.16 to 2.01 mm) after 5 years, compared with 1.07 mm (95% CI, 0.63 to 1.64 mm) and 0.77 mm (95% CI, 0.53 to 1.06 mm) for valgus and in-range knees, respectively (p < 0.001). In contrast, looking at constitutional alignment, loose tibial components were found among both constitutionally in-range and out-of-range knees. Mixed-model analysis showed comparable migration among constitutionally in-range, more-in-varus, and more-in-valgus aligned knees. CONCLUSIONS: Mechanically out-of-range alignment, especially mechanical varus, led to higher tibial component migration. However, matching the constitutional alignment of the patient did not preclude high implant migration. RSA trials randomizing different alignment techniques are needed to confirm the results of the present study. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Marker-based versus model-based radiostereometric analysis of total knee arthroplasty migration: a reanalysis with comparable mean outcomes despite distinct types of measurement error.

Background and purpose - Pooling data of studies evaluating total knee arthroplasty migration using radiostereometric analysis (RSA) may be compromised when the RSA method used would influence estimated differences between groups. We therefore reanalyzed a marker-based RSA study with model-based RSA to assess possible limitations of each RSA method, including insert micromotions in modular TKA and their effect on estimated group differences. Patients and methods - All patients had received a cemented Triathlon implant (Stryker, Mahwah, NJ, USA) with either an all-polyethylene (n = 29) or a metal-backed (n = 28) tibial component. The latter group was reanalyzed with model-based RSA. Precision of each RSA method was calculated using double examinations. Bland-Altman plots were constructed to determine the limits of agreement between the 2 RSA methods. Polyethylene insert micromotion was quantified by measuring migration with respect to the metal tray. Finally, analyses of the original study were repeated with the model-based RSA results. Results - Systematic differences were found in translations between marker-based and model-based RSA as a result of different reference origins being used for migration calculations. Micromotions of the polyethylene insert within the metal tray were negligibly small. Mean migration results were comparable between marker-based and model-based RSA when using the same reference origin, even though conclusions on individual patients may differ between RSA methods due to various types of measurement error (e.g., marker occlusion and model-fit inaccuracies). Interpretation - At least for the studied TKA design, pooling mean migration data of different RSA methods appears justified. For translations, however, adjustments should be made to correct for differences in reference origin. Migration patterns of individual patients may differ as a result of distinct types of measurement error.

Peri-apatite coating decreases uncemented tibial component migration: long-term RSA results of a randomized controlled trial and limitations of short-term results.

Background and purpose - Biological fixation of uncemented knee prostheses can be improved by applying hydroxyapatite coating around the porous surface via a solution deposition technique called Peri-Apatite (PA). The 2-year results of a randomized controlled trial, evaluating the effect of PA, revealed several components with continuous migration in the second postoperative year, particularly in the uncoated group. To evaluate whether absence of early stabilization is diagnostic of loosening, we now present long-term follow-up results. Patients and methods - 60 patients were randomized to PA-coated or uncoated (porous only) total knee arthroplasty of which 58 were evaluated with radiostereometric analysis (RSA) performed at baseline, at 3 months postoperatively and at 1, 2, 5, 7, and 10 years. A linear mixed-effects model was used to analyze the repeated measurements. Results - PA-coated components had a statistically significantly lower mean migration at 10 years of 0.94 mm (95% CI 0.72-1.2) compared with the uncoated group showing a mean migration of 1.72 mm (95% CI 1.4-2.1). Continuous migration in the second postoperative year was seen in 7 uncoated components and in 1 PA-coated component. All of these implants stabilized after 2 years except for 2 uncoated components. Interpretation - Peri-apatite enhances stabilization of uncemented components. The number of components that stabilized after 2 years emphasizes the importance of longer follow-up to determine full stabilization and risk of loosening in uncemented components with biphasic migration profiles.

Migration of all-polyethylene compared with metal-backed tibial components in cemented total knee arthroplasty.

Background and purpose - With a rapidly increasing population in need of total knee arthroplasty (TKA), there is renewed interest in cost-saving all-polyethylene designs. Differences between metal-backed and all-polyethylene designs in initial component migration assessed by radiostereometric analysis (RSA), a proven predictor for late aseptic loosening, have been scantily reported. The purpose of this study was to compare implant migration and clinical outcomes of all-polyethylene tibial components versus metal-backed trays of similar geometrical shape. Patients and methods - In this randomized controlled trial, 59 patients received a cemented Triathlon condylar-stabilizing implant (Stryker, Mahwah, NJ, USA) with either an all-polyethylene (n = 29) or a metal-backed tibial component (n = 30). RSA measurements and clinical scores (the Knee Society Score, Forgotten Joint Score, and Knee Osteoarthritis and Injury Outcome Score) were evaluated at baseline and postoperatively at 3, 12, and 24 months. A linear mixed-effects model was used to analyze the repeated measurements. Results - A statistically significant difference in mean migration after 2 years was found in favor of the all-polyethylene group, with a mean maximum total point motion of 0.61 mm (95% CI 0.49-0.74) versus 0.81 mm (95% CI 0.68-0.96) for the cemented group (p = 0.03). However, this difference was smaller and not statistically significant after post hoc adjustment for surgeon effect. Both groups showed comparable improvements on all clinical outcome scores over time. Interpretation - The Triathlon all-polyethylene tibial component showed less migration, suggesting a lower risk of late loosening as compared with its metal-backed counterpart. However, the found surgeon effect warrants further investigation.

Migration and clinical outcome of mobile-bearing versus fixed-bearing single-radius total knee arthroplasty.

Background and purpose - Mobile-bearing total knee prostheses (TKPs) were developed in the 1970s in an attempt to increase function and improve implant longevity. However, modern fixed-bearing designs like the single-radius TKP may provide similar advantages. We compared tibial component migration measured with radiostereometric analysis (RSA) and clinical outcome of otherwise similarly designed cemented fixed-bearing and mobile-bearing single-radius TKPs. Patients and methods - RSA measurements and clinical scores were assessed in 46 randomized patients at baseline, 6 months, 1 year, and annually thereafter up to 6 years postoperatively. A linear mixed-effects model was used to analyze the repeated measurements. Results - Both groups showed comparable migration (p = 0.3), with a mean migration at 6-year follow-up of 0.90 mm (95% CI 0.49-1.41) for the fixed-bearing group compared with 1.22 mm (95% CI 0.75-1.80) for the mobile-bearing group. Clinical outcomes were similar between groups. 1 fixed-bearing knee was revised for aseptic loosening after 6 years and 2 knees (1 in each group) were revised for late infection. 2 knees (1 in each group) were suspected for loosening due to excessive migration. Another mobile-bearing knee was revised after an insert dislocation due to failure of the locking mechanism 6 weeks postoperatively, after which study inclusion was preliminary terminated. Interpretation - Fixed-bearing and mobile-bearing single-radius TKPs showed similar migration. The latter may, however, expose patients to more complex surgical techniques and risks such as insert dislocations inherent to this rotating-platform design.

Barriers to conducting effective obstetric audit in Ifakara: a qualitative assessment in an under-resourced setting in Tanzania.

OBJECTIVE: To explore barriers to and solutions for effective implementation of obstetric audit at Saint Francis Designated District Hospital in Ifakara, Tanzania, where audit results have been disappointing 2 years after its introduction. METHODS: Qualitative study involving participative observation of audit sessions, followed by 23 in-depth interviews with health workers and managers. Knowledge and perceptions of audit were assessed and suggestions for improvement of the audit process explored. RESULTS: During the observational period, audit sessions were held irregularly and only when the head of department of obstetrics and gynaecology was available. Cases with evident substandard care factors were audited. In-depth interviews revealed inadequate knowledge of the purpose of audit, despite the fact that participants regarded obstetric audit as a potentially useful tool. Insufficient staff commitment, managerial support and human and material resources were mentioned as reasons for weak involvement of health workers and poor implementation of recommendations resulting from audit. Suggestions for improvement included enhancing feedback to all staff and managers to attend sessions and assist with the effectuation of audit recommendations. CONCLUSION: Obstetric staff in Ifakara see audit as an important tool for quality improvement. They recognise, however, that in their own situation, insufficient staff commitment and poor managerial support are barriers to successful implementation. They suggested training in concept and principles of audit as well as strengthening feedback of audit outcomes, to achieve structural health care improvements through audit.