NCT00266396已完成1 期

A Randomized Trial of Weight-bearing Recommendations After Total Hip or Total Knee Arthroplasty

Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein8 个研究点分布在 1 个国家目标入组 352 人开始时间: 2002年1月1日最近更新: 2016年4月6日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 352
试验地点: 8
主要终点: Physical function, measured by means of the Western Ontario and McMaster universities (WOMAC) osteoarthritis index

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Despite the widespread use of total hip and knee arthroplasty, there is a notable lack of consensus regarding postoperative treatment, mostly because of the lack of well-designed studies testing the efficacy and effectiveness of such practices. In particular, there are no evidence-based recommendations on the amount of weight that the patient should be advised to bear on the operated leg after the operation.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Patient who is about to receive unilateral hip or knee replacement surgery on an elective basis for diagnosis of osteoarthritis or femoral head necrosis

排除标准

•A history of septic arthritis,
•Hip fracture,
•Intraoperative complications,
•History of implant surgery on the joint to be operated on,
•Rheumatoid arthritis,
•Amputations,
•Inability to complete the questionnaires because of cognitive or language difficulties.

结局指标

主要结局

Physical function, measured by means of the Western Ontario and McMaster universities (WOMAC) osteoarthritis index

时间窗: Baseline, 3, 6, 12 and 24-months after surgery

次要结局

Quality-Adjusted Life Years(Baseline, 3, 6, 12 and 24-months after surgery)
Physical component summary of the SF-36(Baseline, 3, 6, 12 and 24-months after surgery)
Lequesne Hip resp. Knee Score(Baseline, 3, 6, 12 and 24-months after surgery)
Patient satisfaction(Baseline, 3, 6, 12 and 24-months after surgery)
Leg specific stiffness and pain, both measured by the WOMAC.(Baseline, 3, 6, 12 and 24-months after surgery)

研究者

发起方

Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein

申办方类型

Other

责任方

Principal Investigator

主要研究者

Thoralf R Liebs

Consultant Orthopaedic Surgeon

University Hospital Schleswig-Holstein

研究点 (8)

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