| 1. |
- van der Lelij, Thies J.N., et al.
(author)
-
Continued Stabilization of a Cementless 3D-Printed Total Knee Arthroplasty : Five-Year Results of a Randomized Controlled Trial Using Radiostereometric Analysis
- 2023
-
In: The Journal of bone and joint surgery. American volume. - 1535-1386. ; 105:21, s. 1686-1694
-
Journal article (peer-reviewed)abstract
- 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.
|
|
| 2. |
- VAN DER LELIJ, Thies J.N., et al.
(author)
-
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
- 2024
-
In: Acta Orthopaedica. - 1745-3674. ; 95, s. 157-165
-
Journal article (peer-reviewed)abstract
- 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.
|
|
| 3. |
- Hasan, Shaho, et al.
(author)
-
Late stabilization after initial migration in patients undergoing cemented total knee arthroplasty : a 5-year followup of 2 randomized controlled trials using radiostereometric analysis
- 2022
-
In: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3682 .- 1745-3674. ; 93, s. 271-276
-
Journal article (peer-reviewed)abstract
- 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.
|
|
| 4. |
- Hasan, Shaho, et al.
(author)
-
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
- 2021
-
In: The Journal of bone and joint surgery. American volume. - 1535-1386. ; 103:24, s. 2281-2290
-
Journal article (peer-reviewed)abstract
- 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.
|
|
| 5. |
- Van Hamersveld, Koen T., et al.
(author)
-
Migration of all-polyethylene compared with metal-backed tibial components in cemented total knee arthroplasty : A randomized controlled trial
- 2018
-
In: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3674 .- 1745-3682. ; 89:4, s. 412-417
-
Journal article (peer-reviewed)abstract
- 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.
|
|
| 6. |
- van Hamersveld, Koen T., et al.
(author)
-
Risk Factors for Tibial Component Loosening : A Meta-Analysis of Long-Term Follow-up Radiostereometric Analysis Data
- 2021
-
In: Journal of Bone and Joint Surgery. American volume. - : NLM. - 0021-9355 .- 1535-1386. ; 103:12, s. 1115-1124
-
Journal article (peer-reviewed)abstract
- 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.
|
|
| 7. |
- Hasan, Shaho, et al.
(author)
-
All-polyethylene versus metal-backed posterior stabilized total knee arthroplasty : similar 2-year results of a randomized radiostereometric analysis study
- 2019
-
In: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3674 .- 1745-3682. ; 90:6, s. 590-595
-
Journal article (peer-reviewed)abstract
- 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.
|
|
| 8. |
- Hoogervorst, Lotje A., et al.
(author)
-
Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle : A Systematic Review
- 2023
-
In: International Journal of Health Policy and Management. - : Kerman University of Medical Sciences. - 2322-5939. ; 12:1, s. 1-11
-
Research review (peer-reviewed)abstract
- Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformite Europeenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.Methods: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes.Results: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations.Conclusion: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.
|
|
