Background:Radiostereometric analysis (RSA) provides highly accurate data about the migration of a total knee arthroplasty (TKA) component. However, patient-reported outcome measures (PROMs) reflect the patients' perspective of their functional status, pain, and overall health after TKA. The aim of this study was to evaluate the association between tibial implant migration and change in postoperative PROMs and clinical scores, using data pooled from long-Term follow-up RSA studies.Methods:Individual implant migration data were collected from 5 randomized RSA studies, including a total of 300 patients with 6 distinct TKA implant designs (all Stryker). Tibial implant migration (maximum total point motion [MTPM]) was evaluated with RSA at 3 months, 1 year, and 2, 5, 7, and 10 years postoperatively. The Knee Society Score (KSS)-Knee and KSS-Function and Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales were collected in all studies at the same follow-up times. Linear mixed-effects models, with adjustment for TKA implant design and patient characteristics, were used to analyze the data. The 3-month follow-up visit was used as the baseline to assess the association between implant migration and PROMs across the 10-year follow-up.Results:No association between tibial implant migration and change in KSS-Knee (p = 0.384), KSS-Function (p = 0.737), KOOS-Symptoms (p = 0.398), KOOS-Pain (p = 0.699), KOOS-Activities of Daily Living (p = 0.205), KOOS-Sport and Recreation (p = 0.702), or KOOS-Quality of Life (p = 0.368) was found across the entire follow-up. Similar results were found when using the 2-year follow-up as the baseline, after which both cemented and uncemented implants are expected to have stabilized.Conclusions:Tibial baseplate migration was not associated with postoperative worsening in PROMs or clinical scores in patients who underwent TKA. These findings suggest that implant migration, as measured with RSA, measures a different parameter (i.e., implant-bone fixation) than PROMs (i.e., patient perception) and clinical scores. Therefore, to assess the performance and safety of TKA implant designs, RSA and PROMs cannot be used interchangeably during the postoperative follow-up of patients and evaluation of the fixation of knee implants.Level of Evidence:Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

@en

Background and purpose — Different marker-selection methods are applied to represent implant and tibial seg-ments 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 evalu-ated 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.

@en

Background: Loosening is a major cause for failure of total hip and total knee arthroplasties (THAs/TKAs). Preemptive diagnostics of asymptomatic loosening could open strategies to prevent gross loosening. A multitude of biomarkers may discriminate between loosened and stable implants, but it is unknown which have the best performance. The present systematic review aimed to assess which biomarkers have shown the most promising results in discriminating between stable and aseptic loosened THAs and TKAs.

Methods: PubMed, Embase, Web of Science, Cochrane Library, and Academic Search Premier were systematically searched up to January 2020 for studies including THA/TKA and biomarkers to assess loosening. Two reviewers independently screened records, extracted data, and assessed the risk of bias using the ICROMS tool to classify the quality of the studies.

Results: Twenty-eight (three high-quality) studies were included, reporting on a median of 48 patients (interquartile range 28–69). Serum and urine markers were evaluated in 22 and 10 studies, respectively. Tumor necrosis factor α and osteocalcin were significantly higher in loosened compared with stable implants. Urinary N-terminal telopeptide had significantly elevated levels in loosened prostheses.

Conclusion: Several serum and urine markers were promising in discriminating between loosened and stable implants. We recommend future studies to evaluate these biomarkers in a longitudinal fashion to assess whether progression of loosening is associated with a change in these biomarkers. In particular, high-quality studies assessing the usability of these biomarkers are needed.

@en

BACKGROUND: Three-dimensional (3D) printing of highly porous orthopaedic implants aims to promote better osseointegration, thus preventing aseptic loosening. However, short-term radiostereometric analysis (RSA) after total knee arthroplasty (TKA) has shown higher initial migration of cementless 3D-printed tibial components compared with their cemented counterparts. Therefore, critical evaluation of longer-term tibial component migration is needed. We investigated migration of a cementless 3D-printed and a cemented tibial component with otherwise similar TKA design during 5 years of follow-up, particularly the progression in migration beyond 2 years postoperatively. METHODS: Seventy-two patients were randomized to a cementless 3D-printed Triathlon Tritanium (Stryker) cruciate-retaining (CR) TKA or a cemented Triathlon CR (Stryker) TKA implant. Implant migration was evaluated with RSA at baseline and postoperatively at 3 months and at 1, 2, and 5 years. The maximum total point motion (MTPM) of the tibial component was compared between the groups at 5 years, and progression in migration was assessed between 2 and 5 years. Individual implants were classified as continuously migrating if the MTPM was ≥0.1 mm/year beyond 2 years postoperatively. Clinical scores were evaluated, and a linear mixed-effects model was used to analyze repeated measurements. RESULTS: At 5 years, the mean MTPM was 0.66 mm (95% confidence interval [CI], 0.56 to 0.78 mm) for the cementless group and 0.53 mm (95% CI, 0.43 to 0.64 mm) for the cemented group (p = 0.09). Between 2 and 5 years, there was no progression in mean MTPM for the cementless group (0.02 mm; 95% CI, -0.06 to 0.10 mm) versus 0.07 mm (95% CI, 0.00 to 0.14) for the cemented group. One implant was continuously migrating in the cementless group, and 4 were continuously migrating in the cemented group. The clinical scores were comparable between the groups across the entire time of follow-up. CONCLUSIONS: No significant difference in mean migration was found at 5 years between the cementless and cemented TKA implants. Progression of tibial component migration was present beyond 2 years for the cemented implant, whereas the cementless implant remained stable after initial early migration. LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

@en

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.@en

Introduction: Excellent long-term survival has been reported for both the Taperloc and the Mallory-Head cementless stems. However, little is known about the migration behaviour of these stems which have different design rationales. The purpose of this randomised clinical trial was to compare the migration and clinical outcomes of these stems during 5 years of follow-up. Methods: 42 consecutive hips in 38 patients scheduled to receive cementless THA were randomised to either a Taperloc or a Mallory-Head stem. Evaluation took place preoperatively and postoperatively on the second day, at 6, 12, 26, and 52 weeks, and annually thereafter. Primary outcome was stem migration measured using roentgen stereophotogrammetric analysis (RSA) and secondary outcomes were the Harris Hip Score (HHS) and 36-Item Short-Form Health Survey (SF-36). No patients were lost to follow-up; in 1 patient the THA was removed due to deep infection 3 months postoperatively. In 6 hips migration measurements were not possible due to insufficient marker configuration. Results: Throughout the follow-up period of 5 years, 3-dimensional migration was comparable between the Taperloc and the Mallory-Head stems (p-values > 0.05). However, at the 5-year follow-up point the retroversion of the Mallory-Head stem was 0.9° more than the Taperloc stem (p = 0.04). Initial subsidence and retroversion were respectively as large as 6.8 mm and 3.6° for the Taperloc stem and 5 mm and 3.6° for the Mallory-Head stem. After the first postoperative year, both implants had stabilised. The mean increment of HHS, as well as the SF-36 scores during the 5-year follow-up, were comparable between the 2 stems. Conclusions: The excellent long-term survival of both designs was confirmed in this study showing comparable initial migration with subsequent stabilisation. However, the Taperloc design with a flat, wedged geometry showed better rotational stability.

@en

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.@en

BackgroundThe number of revisions after TKA is expected to rise because of aging populations in many countries and because patients are undergoing TKA at younger ages. Aseptic loosening is a major reason for late revision, which can be predicted by radiostereometric analysis (RSA) of small groups of patients at 2 years of follow-up. RSA is therefore an ideal tool to assess new TKA designs before they are introduced to the market, although not every TKA design has been studied with RSA. If RSA-tested TKA designs have lower 10-year revision rates in national registries than non-RSA-tested TKA designs, RSA testing of all new designs could be advocated.Questions/purposesIn this study, we asked: Is there a difference in the all-cause revision rate between non-RSA-tested and RSA-tested TKA designs registered in national knee arthroplasty registries at 5 and 10 years of follow-up?MethodsKnee arthroplasty registries were identified through the European Federation of National Associations of Orthopaedics and Traumatology webpage and through a manual internet search. Inclusion criteria were a minimum follow-up duration of 10 years and available revision or survival data per TKA design. Twenty-six registries were identified; seven were included comprising 339 TKA designs, of which 236 designs were classified as RSA-tested and 103 as non-RSA-tested. Six registries were excluded because no report was published. One registry was excluded because no fixation method was mentioned (79 TKA designs). Another registry was excluded because there was no 10-year data available (22 non-RSA-tested designs; 10 RSA-tested designs). Eleven registries were excluded because they did not provide revision rates per design and had not reached 10 years follow-up. The revision rates with their standard errors were extracted per design. We used the data from a recent meta-analysis to identify whether a TKA design was previously tested with RSA. This meta-analysis found 53 RSA studies comprising 70 different TKA designs. The prosthesis model, fixation method and insert type were extracted from these RSA-studies. The design characteristics of the TKA reported in the knee arthroplasty registries were also extracted, and if possible, matched to the TKA designs reported in the RSA-studies. At 5 years of follow-up, 191 TKA designs were identified as non-RSA-tested and 92 were identified as RSA-tested. At 10 years of follow-up, 154 TKA designs and 74 TKA designs were classified as non-RSA-tested and RSA-tested, respectively. A random-effects model using the Metafor Package in R statistics was used to estimate the pooled revision rate at 5 and 10 years of follow-up for both groups. The difference in revision rates between groups at 5 and 10 years of follow-up was estimated by including RSA as a factor in the random-effects model.ResultsMean all-cause revision rates at 5 years for non-RSA-tested and RSA-tested implants were 3.6% (95% CI 3.4 to 3.8) and 2.9% (95% CI 2.7 to 3.0), with a mean difference of 0.6% favoring RSA-tested implants (95% CI 0.4 to 0.8; p < 0.001). Mean all-cause revision rates at 10 years for non-RSA-tested and RSA-tested implants were 5.5% (95% CI 5.2 to 5.9) and 4.4% (95% CI 4.1 to 4.7), with a mean difference of 0.9% favoring RSA-tested implants (95% CI 0.4 to 1.3; p < 0.001).ConclusionsAlthough there are exceptions, across registries, TKA designs that have been tested in an RSA setting have a slightly lower (about 1%) mean all-cause revision rate at 5-year and 10-year follow-up than those tested in a non-RSA setting. Acknowledging the inherent limitations of this observational study, a risk difference of 1% could potentially translate into an approximate 20% decrease in revision burden up to 10 years, which may have a profound impact on patient morbidity and health-related costs.Level of EvidenceLevel III, therapeutic study.@en

Background and purpose — Little is known about the long-term migration pattern of cementless stems in total hip arthroplasty (THA). Furthermore, the role of bioactive coatings in fixation, and thus migration, remains uncertain. Hydroxyapatite (HA) is the most commonly used bioactive coating. However, delamination of the coating might induce loosening. Alternatively, fluorapatite (FA) has proved to be more thermostable than HA, thereby potentially increasing longevity. We assessed the long-term migration of cementless stems with different coatings using radiostereometric analysis (RSA), thereby establishing a reference for acceptable migration. Patients and methods — 61 THAs in 53 patients were randomized to receive either a HA, FA, or uncoated Mallory-Head Porous stem during the years 1992 to 1994. Primary outcome was stem migration measured using RSA and secondary outcome was the Harris Hip Score (HHS). Evaluation took place preoperatively and postoperatively on the second day, at 6, 12, 25 and 52 weeks, and annually thereafter. At the 25-year follow-up, 12 patients (17 THAs) had died and 1 patient (1 THA) was lost to follow-up. Due to the high number of missing second-day postoperative RSA radiographs, the 1-year postoperative RSA radiograph was used as baseline for the comparative analyses. Results — Mean follow-up was 17 years (SD 6.6). All stems showed initial rapid migration with median subsidence of 0.2 mm (–0.1 to 0.6) and median retroversion of 0.9° (–3.2 to 2) at 12 months, followed by stable migration reaching a plateau phase. No stem was revised, albeit 1 stem showed continuous subsidence up to 1.5 mm. Comparing the different coatings, we could not find a statistically significant difference in overall 25-year migration (p-values > 0.05). Median subsidence at 15-year follow-up was for HA –0.1 mm (–0.4 to 0.2), for FA 0 mm (–0.1 to 0.2), and for uncoated stems 0.2 mm (–0.1 to 0.5). Median internal rotation at 15-year follow-up was for HA not available, for FA 1.1° (–0.5 to 2.6), and for uncoated stems 0° (–0.5 to 0.4). HHS were also comparable (p-values > 0.05), with at 15-year follow-up for HA 85 points (41–99), for FA 76 points (61–90), and for uncoated stems 79 points (74–90). Interpretation — The long-term migration pattern of cementless stems using different bioactive coatings has not previously been described. No beneficial effect, or side effect at long-term follow-up of bioactive coatings, was found. The provided migration data can be used in future research to establish thresholds for acceptable migration patterns cementless stem designs.

@en

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.@en

Background and purpose — The all-polyethylene tibial (APT) component, introduced in the early 1970s, was surpassed by metal-backed tibial (MBT) trays as the first choice for total knee arthroplasty (TKA). With improved polyethylene, the modern APT components can reduce costs, and have shown equivalent results in survivorship and early migration of the cruciate-retaining and cruciate-stabilizing designs. This study compares the 2-year migration of a similarly designed APT-posterior stabilized (PS) and a MBT-PS TKA, using radiostereometric analysis (RSA). Patients and methods — 60 patients were randomized to receive either an APT Triathlon PS or an MBT Triathlon PS TKA (Stryker, NJ, USA). Migration measured by RSA and clinical scores were evaluated at baseline and at 3, 12, and 24 months postoperatively. Repeated measurements were analyzed with a linear mixed model and generalized estimating equations. Results — The mean maximum total point movement (MTPM) at 3, 12, and 24 months was 0.41 mm (95% CI 0.33–0.50), 0.57 mm (0.44–0.70), and 0.56 mm (0.42–0.69) respectively in the MBT group and 0.46 mm (0.36–0.57), 0.61 mm (0.49–0.73), and 0.64 mm (0.50–0.77) in the APT group. 2 MBT and 1 APT implant were considered unstable at the 2-year follow-up. The KSS Knee score and KSS Function across 3, 12, and 24 months were comparable in both groups. Interpretation — For an APT-PS designed component, MTPM measured with RSA is comparable to the MBT-PS component after 2 years of follow-up. No differences in complications or clinical outcomes were found.@en

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.@en

Background and purpose — Stability and survival of cemented total hip prostheses is dependent on a multitude of factors, including the type of cement that is used. Bone cements vary in viscosity, from low to medium and high. There have been few clinical RSA studies comparing the performance of low- and high-viscosity bone cements. We compared the migration behavior of the Stanmore hip stem cemented using novel low-viscosity Palamed bone cement with that of the same stem cemented with conventional high-viscosity Palacos bone cement. Patients and methods — We performed a randomized controlled study involving 39 patients (40 hips) undergoing primary total hip replacement for primary or secondary osteoarthritis. 22 patients (22 hips) were randomized to Palacos and 17 patients (18 hips) were randomized to Palamed. Migration was determined by RSA. Results — None of these 40 hips had been revised at the 10-year follow-up mark. To our knowledge, the patients who died before they reached the 10-year endpoint still had the implant in situ. No statistically significant or clinically significant differences were found between the 2 groups for mean translations, rotations, and maximum total-point motion (MTPM). Interpretation — We found similar migration of the Stanmore stem in the high-viscosity Palacos cement group and the low-viscosity Palamed cement group. We therefore expect that the risk of aseptic loosening with the new Palamed cement would be comparable to that with the conventional Palacos cement. The choice of which type of bone cement to use is therefore up to the surgeon’s preference.

@en