Lützner Jörg, Beyer Franziska, Lützner Cornelia, Tille Eric, Postler Anne Elisabeth
University Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital, TU Dresden, Dresden, Germany.
J Arthroplasty. 2023 Jan;38(1):90-95.e1. doi: 10.1016/j.arth.2022.07.014. Epub 2022 Jul 31.
This randomized-controlled trial was initiated to compare a new multilayer hypoallergenic coating system with the standard implant in total knee arthroplasty (TKA) in terms of serum metal ion levels, patient-reported outcomes (PROs), and implant survival.
A total of 120 patients were randomized to receive a coated or standard TKA of the same knee system. Serum metal ion levels (ie, cobalt, chromium, molybdenum, and nickel) as well as knee function (Oxford Knee Score, OKS), quality of life (SF-36), and physical activity (UCLA activity scale) were assessed before surgery and until the 10 year follow-up. A total of 24 patients died and there was one revision in each group. This resulted in 85 patients who completed follow-up.
Both groups demonstrated equally good improvement in PROs after surgery and constant score values thereafter. The majority of patients had metal ion serum levels below detection limit. Only cobalt levels demonstrated a slight increase in the standard group at 5- and 10-year follow-up. However, all patients displayed values below 3 μg/L. The cumulative 10-year survival was 98% in both groups.
There were no problems with the new coating system. No relevant increase in metal ion serum levels were measured. A slight increase in cobalt serum levels in the standard TKA was noted, thus not reaching critical values. The new coating system demonstrated equally good PROs as the standard TKA. Excellent implant survival was observed in both groups.
I.
开展这项随机对照试验的目的是，比较一种新型多层低敏涂层系统与全膝关节置换术（TKA）中的标准植入物在血清金属离子水平、患者报告结局（PROs）和植入物生存率方面的差异。
总共120例患者被随机分配，接受同一膝关节系统的涂层或标准TKA。在手术前以及直至10年随访期，评估血清金属离子水平（即钴、铬、钼和镍）以及膝关节功能（牛津膝关节评分，OKS）、生活质量（SF-36）和身体活动水平（加州大学洛杉矶分校活动量表）。共有24例患者死亡，每组各有1例翻修手术。这使得85例患者完成了随访。
两组患者术后PROs均有同样良好的改善，且此后评分值保持稳定。大多数患者的金属离子血清水平低于检测限。仅在5年和10年随访时，标准组的钴水平略有升高。然而，所有患者的钴水平均低于3μg/L。两组的10年累积生存率均为98%。
新涂层系统没有问题。未检测到金属离子血清水平有相关升高。注意到标准TKA中钴血清水平略有升高，但未达到临界值。新涂层系统与标准TKA在PROs方面表现同样良好。两组均观察到优异的植入物生存率。
I级
