髋关节或膝关节全关节置换术作为骨关节炎结构改变试验的一项结局指标。

Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis.

作者信息

Altman R D, Abadie E, Avouac B, Bouvenot G, Branco J, Bruyere O, Calvo G, Devogelaer J-P, Dreiser R L, Herrero-Beaumont G, Kahan A, Kreutz G, Laslop A, Lemmel E M, Menkes C J, Pavelka K, Van De Putte L, Vanhaelst L, Reginster J-Y

机构信息

Rheumatology and Immunology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.

出版信息

Osteoarthritis Cartilage. 2005 Jan;13(1):13-9. doi: 10.1016/j.joca.2004.10.012.

DOI:10.1016/j.joca.2004.10.012

PMID:15639632

Abstract

OBJECTIVE

The Group for the Respect of Ethics and Excellence in Science (GREES) organized a working group to assess the value of time to joint surgery as a potential therapeutic failure outcome criterion for osteoarthritis (OA) of the hip or knee in the assessment of potential structure modifying agents.

METHODS

PubMed was searched for manuscripts from 1976 to 2004. Relevant studies were discussed at a 1-day meeting.

RESULTS

There are no accepted guidelines for 'time to' and 'indications for' joint replacement surgery. A limited number of trials have examined joint replacement surgery within the study population. Several parameters, particularly joint space narrowing (interbone distance), correlate with surgical intervention. However, at the level of the knee, none of the parameters have positive predictive value for joint replacement surgery better than 30%. In contrast, lack of significant joint space narrowing has a strong negative predictive value for joint replacement surgery (>90%), that remains after controlling for OA pain severity.

CONCLUSION

At this time, GREES cannot recommend time to joint surgery as a primary endpoint of failure for structure modifying trials of hip or knee OA-as the parameter has sensitivity but lacks specificity. In contrast, in existing trials, a lack of progression of joint space narrowing has predictive value of >90% for not having surgery. GREES suggests utilizing joint space narrowing (e.g., >0.3-0.7 mm) combined with a lack of clinically relevant improvement in symptoms (e.g., >/=20-25%) for 'failure' of a secondary outcome in structure modifying trials of the hip and knee.

摘要

目的

科学伦理与卓越小组（GREES）组织了一个工作组，以评估关节置换手术时间作为髋或膝骨关节炎（OA）潜在治疗失败结局标准在评估潜在结构改善剂方面的价值。

方法

检索了1976年至2004年PubMed上的手稿。在为期1天的会议上讨论了相关研究。

结果

对于关节置换手术的“时间”和“适应症”，尚无公认的指南。在研究人群中，仅有少数试验对关节置换手术进行了研究。几个参数，特别是关节间隙变窄（骨间距离），与手术干预相关。然而，在膝关节层面，对于关节置换手术，没有一个参数的阳性预测价值能超过30%。相比之下，关节间隙无明显变窄对于关节置换手术具有很强的阴性预测价值（>90%），在控制OA疼痛严重程度后该价值依然存在。

结论

目前，GREES不能推荐将关节置换手术时间作为髋或膝OA结构改善试验失败的主要终点——因为该参数具有敏感性但缺乏特异性。相比之下，在现有试验中，关节间隙变窄无进展对于不进行手术具有>90%的预测价值。GREES建议在髋和膝结构改善试验的次要结局“失败”评估中，利用关节间隙变窄（如>0.3 - 0.7毫米）并结合症状无临床相关改善（如≥20 - 25%）。