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氮化钛涂层在非骨水泥活动平台全膝关节置换术中无临床益处。

No clinical benefit of titanium nitride coating in cementless mobile-bearing total knee arthroplasty.

作者信息

van Hove Ruud P, Brohet Richard M, van Royen Barend J, Nolte Peter A

机构信息

Department of Orthopaedics, Spaarne Hospital, Spaarnepoort 1, 2134 TM, Hoofddorp, The Netherlands,

出版信息

Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1833-40. doi: 10.1007/s00167-014-3359-9. Epub 2014 Oct 5.

Abstract

PURPOSE

Titanium nitride (TiN) coating of cobalt-chromium-molybdenum (CoCrMo) implants has shown to improve the biomechanical properties of the implant surface and to reduce adhesive wear in vitro. It is yet unknown whether TiN coating of total knee prosthesis (TKP) affects the postoperative clinical outcome of total knee arthroplasty (TKA).

METHODS

In a double-blind randomized controlled clinical trial, 101 patients received an uncemented mobile-bearing CoCrMo TKP, either TiN coated or uncoated. Primary outcome measure visual analogue scale (VAS) score for pain, and secondary outcome measures Knee Society Score (KSS), revision rate and adverse events, range of motion of the knee as well as knee circumference and knee skin temperature were assessed 6 weeks, 6 months, 1 year and 5 years postoperative. Repeated measures analysis was used to evaluate the postoperative outcome measures over time.

RESULTS

There was no difference between the two groups in VAS score, KSS, revision rate, range of motion of the knee, knee circumference and knee skin temperature. There were no adverse events that could be related to the TiN coating.

CONCLUSIONS

TiN-coated TKP does not influence the postoperative outcome of uncemented mobile-bearing TKA regarding postoperative pain, revision rate, range of motion, swelling and temperature of the knee. Therefore, TiN coating of CoCrMo TKP has no clinical benefit on the outcome of cementless mobile-bearing TKA.

LEVEL OF EVIDENCE

Therapeutic study, Level I.

摘要

目的

钴铬钼(CoCrMo)植入物的氮化钛(TiN)涂层已显示出可改善植入物表面的生物力学性能并减少体外的粘着磨损。全膝关节假体(TKP)的TiN涂层是否会影响全膝关节置换术(TKA)的术后临床结果尚不清楚。

方法

在一项双盲随机对照临床试验中,101例患者接受了非骨水泥活动轴承CoCrMo TKP,涂层或未涂层。主要结局指标为疼痛的视觉模拟量表(VAS)评分,次要结局指标包括膝关节协会评分(KSS)、翻修率和不良事件、膝关节活动范围以及膝关节周长和膝关节皮肤温度,在术后6周、6个月、1年和5年进行评估。采用重复测量分析来评估术后不同时间的结局指标。

结果

两组在VAS评分、KSS、翻修率、膝关节活动范围、膝关节周长和膝关节皮肤温度方面无差异。没有与TiN涂层相关的不良事件。

结论

TiN涂层的TKP在术后疼痛、翻修率、活动范围、膝关节肿胀和温度方面不影响非骨水泥活动轴承TKA的术后结果。因此,CoCrMo TKP的TiN涂层对非骨水泥活动轴承TKA的结果没有临床益处。

证据水平

治疗性研究,I级。

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