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... Show moreBackground 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 posterior-stabilizing (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 follow-up to determine whether second-year continuous migration correctly predicts loosening. Show less
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... Show moreBackground: 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. Show less
The longevity of total knee implants may be impaired by aseptic loosening of the components within the bone. Aseptic loosening remains the leading cause of revision surgery. In the past decades,... Show moreThe longevity of total knee implants may be impaired by aseptic loosening of the components within the bone. Aseptic loosening remains the leading cause of revision surgery. In the past decades, many implant design aspects and surgical techniques have been changed in an attempt to decrease the risk of loosening. Given that radiostereometric analysis (RSA) is a highly accurate method to detect early implant migration which is predictive for late loosening, new implant designs should ideally be tested with RSA before widespread introduction onto the market. In this thesis, we present the results of four randomized controlled trials studying the effect of such changes in design on implant migration with use of RSA. We also pooled several RSA studies to be able to analyze the effect of other possible risk factors, including patient characteristics and surgical technique. We show that slight changes in implant design may increase the risk of loosening considerably, while other factors that are often thought to be associated with an increased risk (such as a high body mass index) do not appear to have a large effect. Show less
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... Show moreBackground: 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. Show less
Hasan, S.; Hamersveld, K.T. van; Marang-van de Mheen, P.J.; Kaptein, B.L.; Nelissen, R.G.H.H.; Toksvig-Larsen, S. 2020
AimsAlthough 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.... Show moreAimsAlthough 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.MethodsA 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.ResultsThe 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.ConclusionThe 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. Show less
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... Show moreBackground 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. Show less
Hamersveld, K.T. van; Marang-van de Mheen, P.J.; Nelissen, R.G.H.H. 2019
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... Show moreBackground: 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 degrees 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. Show less
Hamersveld, K.T. van; Marang-Van De Mheen, P.J.; Heide, H.J.L. van der; Linden-Van Der Zwaag, H.M.J. van der; Valstar, E.R.; Nelissen, R.G.H.H. 2018
