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Equal tibial component fixation of a mobile-bearing and fixed-bearing medial unicompartmental knee arthroplasty: a randomized controlled RSA study with 2-year follow-up

机译:相同的胫骨成分固定移动轴承和固定内侧外侧膝关节置换术:随机控制RSA研究,具有2年的随访

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摘要

Background and purpose — Differences in stress distribution in a mobile-bearing and fixed-bearing unicompartmental knee arthroplasty (UKA) design might lead to a difference in fixation of the tibial component. We compared tibial component migration of a mobile-bearing (MB) UKA and a fixed-bearing (FB) UKA using radiostereometric analysis. Patients and methods — In a randomized, patient-blinded clinical trial 62 patients received either the MB Oxford UKA or the FB Sigma UKA. The patients were followed for 24 months with radiostereometric analysis. Clinical outcome was assessed with Oxford Knee Score (OKS), RAND-36 and leg extension power. Results — Migration of the tibial components was similar between groups throughout follow-up. At 12 months, MTPM of the tibial component was 0.44 mm (95% CI 0.34–0.55) for the MB group and 0.40 mm (CI 0.31–0.50) for the FB group. Between 12 and 24 months, the tibial components migrated with a median MTPM increase of 0.03 mm (CI –0.02 to 0.08) in the MB group and 0.03 mm (CI –0.02 to 0.07) in the FB group. Continuous migration of the tibial component was found for 1 MB UKA and 2 FB UKAs. Both groups showed similar and clinically relevant improvement in clinical outcome. Interpretation — MB and FB tibial components had similar good fixation and clinical improvement until 2 years. Based on this study, a low 5- to 10-year revision rate can be expected for both implants. Trial registration: ClinicalTrials.gov identifier: NCT03434600.
机译:背景和目的 - 移动轴承和固定的Unicompateal膝关节置换术(UKA)设计中应力分布的差异可能导致胫骨组分的固定差异。我们使用射频分析比较了移动轴承(MB)UKA的胫骨部件迁移和固定轴承(FB)UKA。患者和方法 - 在随机,患者盲临临床试验62患者接受MB牛津UKA或FB Sigma UKA。患者随访24个月,具有辐射测量分析。用牛津膝关节分数(OK),RAND-36和腿部延长功率评估临床结果。结果 - 胫骨组分的迁移在整个后续后的组之间相似。在12个月时,胫骨组分的MTPM为MB组为0.44mm(95%CI 0.34-0.55),FB组为0.40mm(CI 0.31-0.50)。在12到24个月之间,在MB组中,胫骨组分迁移到MB组中的中位数MTPM增加0.03mm(CI -0.02至0.08)和FB组中的0.03mm(CI -0.02至0.07)。发现胫骨组分的连续迁移为1 MB UKA和2 FB UKAS。两组在临床结果中表现出类似和临床相关的改善。解释 - MB和FB胫骨组分在2年内具有相似的良好固定和临床改善。基于这项研究,植入物可以预期低5至10年的修订率。试验注册:ClinicalTrials.gov标识符:NCT03434600。

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