Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New York.
Biostatistics Core, Hospital for Special Surgery, New York, New York.
J Arthroplasty. 2023 Jun;38(6S):S290-S296.e1. doi: 10.1016/j.arth.2023.03.005. Epub 2023 Mar 11.
A specific total knee arthroplasty (TKA) implant system was recently recalled for high incidence of early polymeric wear and osteolysis. We analyzed the early outcomes of aseptic revision with these implants.
We identified 202 aseptic revision TKAs of this implant system performed at a single institution between 2010 and 2020. Revision indications included aseptic loosening (n = 120), instability (n = 55), and polymeric wear/osteolysis (n = 27). Components were revised in 145 cases (72%) and isolated polyethylene insert exchange occurred in 57 cases (28%). Kaplan-Meier and Cox proportional hazards analyses were used to determine survivorship free from all-cause rerevision and rerevision risk factors.
At 2 and 5 years, survivorship free from all-cause rerevision was 89 and 76% in the polyethylene exchange cohort versus 92 and 84% in the component revision cohort (P = .5). At 2 and 5 years, survivorship in revision with components from the same manufacturer was 89 and 80% compared to 95 and 86% in revision with components from a different manufacturer (P = .2). Among re-revisions (n = 30), cones (37%), sleeves (7%), hinge/distal femoral replacement implants were frequently used (13%). Men had increased risk for rerevision (hazard ratio = 2.3, P = .04).
In this series of aseptic revision TKAs performed on a now-recalled implant system, survivorship free from rerevision was lower than expected when components from the same manufacturer were utilized, but comparable to contemporary reports when both the components were revised with an alternative implant system. Metaphyseal fixation with cones and sleeves as well as highly constrained implants was frequently utilized at time of rerevision TKA.
Level IV.
一种特定的全膝关节置换（TKA）植入系统最近因早期高分子磨损和骨溶解的高发而被召回。我们分析了使用这些植入物进行无菌翻修的早期结果。
我们在一家机构中确定了 202 例这种植入系统的无菌翻修 TKA，这些病例发生在 2010 年至 2020 年之间。翻修指征包括无菌性松动（n=120）、不稳定（n=55）和高分子磨损/骨溶解（n=27）。145 例（72%）进行了翻修，57 例（28%）进行了单独的聚乙烯插入物置换。采用 Kaplan-Meier 和 Cox 比例风险分析来确定免于全因再次翻修的生存率和再次翻修的危险因素。
在聚乙烯置换组，2 年和 5 年时，免于全因再次翻修的生存率分别为 89%和 76%，而在组件翻修组，2 年和 5 年时，免于全因再次翻修的生存率分别为 92%和 84%（P=0.5）。在同一制造商的组件进行翻修的情况下，2 年和 5 年时的生存率分别为 89%和 80%，而在不同制造商的组件进行翻修的情况下，2 年和 5 年时的生存率分别为 95%和 86%（P=0.2）。在再次翻修（n=30）中，锥体（37%）、衬套（7%）、铰链/远端股骨置换植入物经常被使用（13%）。男性再次翻修的风险增加（风险比=2.3，P=0.04）。
在对现在被召回的植入系统进行的无菌翻修 TKA 系列中，当使用同一制造商的组件时，免于再次翻修的生存率低于预期，但当使用另一种植入系统同时翻修所有组件时，与当代报告相比，生存率是可比的。在再次翻修 TKA 时，经常使用锥体和衬套进行骨髓固定以及高度约束性植入物。
IV 级。
