Department of Orthopaedic Surgery, Spaarne Gasthuis Hospital, Hoofddorp, The Netherlands.
Department of Orthopaedic Surgery, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
Knee Surg Sports Traumatol Arthrosc. 2021 Mar;29(3):750-756. doi: 10.1007/s00167-020-05997-4. Epub 2020 May 4.
Improvement of biomechanical properties of cobalt-chromium-molybdenum (CoCrMo) implant surface and reduction of adhesive wear is achieved by titanium-nitride (TiN) coating in vitro. Less pain, higher postoperative outcome scores and a lower revision rate after TKA with a TiN-coated CoCrMo TKA compared with uncoated CoCrMo TKA after 10-year follow-up was hypothesized.
In a double-blinded RCT, 101 patients received a cementless mobile-bearing CoCrMo TKA, either TiN-coated or uncoated. The primary outcome measure was the visual analogue scale (VAS) score for pain and secondary outcome measures were the Knee Society Score (KSS), Oxford Knee Score (OKS), revision rate and adverse events. Patients were assessed at 6 weeks, 6 months, 1 year, 5 years and 10 years, postoperatively.
68 patients (67%) were available for 10-year follow-up. No difference was found in any of the assessed outcome measures with a mean decrease in VAS score (31.6 ± 22.9) and a mean increase in OKS (10.9 ± 8.4), KSS (29.3 ± 31.4), KSSK (26.4 ± 18.2) and KSSF (4.1 ± 22.9). Overall revision rate was 7% (coated 6% vs uncoated 8%) without additional revision procedures between 5 and 10-year follow-up.
The in vitro potential benefits of TiN coating did not result in better clinical outcome when compared to an uncoated cementless TKA. Pain, functional outcome and revision rates were comparable after 10-year follow-up. TiN-coated cementless TKA provides comparable good long-term results, similar to uncoated cementless CoCrMo TKA.
Level 1, Therapeutic Study NETHERLANDS TRIAL REGISTER: NL2887/NTR3033.
通过在体外对钴铬钼（CoCrMo）植入物表面进行氮化钛（TiN）涂层处理，可提高其生物力学性能并减少粘着磨损。假设与未经涂层处理的 CoCrMo TKA 相比，经过 10 年随访后，接受 TiN 涂层 CoCrMo TKA 的 TKA 患者疼痛程度更低，术后结果评分更高，翻修率更低。
在一项双盲 RCT 中，101 例患者接受了非骨水泥固定的活动衬垫 CoCrMo TKA，分为 TiN 涂层组和未涂层组。主要观察指标为疼痛的视觉模拟评分（VAS），次要观察指标为膝关节学会评分（KSS）、牛津膝关节评分（OKS）、翻修率和不良事件。术后 6 周、6 个月、1 年、5 年和 10 年对患者进行评估。
68 例患者（67%）完成了 10 年随访。在任何评估指标中，VAS 评分的平均下降值（31.6±22.9）和 OKS 的平均增加值（10.9±8.4）、KSS（29.3±31.4）、KSSK（26.4±18.2）和 KSSF（4.1±22.9）均无差异。总体翻修率为 7%（涂层组为 6%，未涂层组为 8%），5 年至 10 年随访期间无需进行额外的翻修手术。
与未涂层的非骨水泥 TKA 相比，TiN 涂层的体外潜在优势并未带来更好的临床结果。在 10 年随访时，疼痛、功能结果和翻修率相当。TiN 涂层的非骨水泥 TKA 可提供类似的良好长期结果，与未涂层的非骨水泥 CoCrMo TKA 相当。
1 级，治疗研究荷兰临床试验注册中心：NL2887/NTR3033。
