RCT Multicenter Comparison of Patient-Specific Versus Conventional Instrumentation in Primary TKA

Cochin Hospital0 个研究点目标入组 140 人2011年9月

适应症Osteoarthritis, Knee

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Osteoarthritis, Knee
发起方: Cochin Hospital
入组人数: 140
主要终点: Mechanical axis
状态: 已完成
最后更新: 12年前

概览研究者入排标准结局指标相似试验

概览

简要总结

The aim of this prospective multicenter randomized clinical trial (RCT) is to compare the clinical and radiologic results of primary total knee arthroplasty (TKA) using patient-specific versus conventional instrumentation.

注册库

clinicaltrials.gov

开始日期

2011年9月

结束日期

2013年7月

最后更新

12年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Cochin Hospital

责任方

Principal Investigator

主要研究者

Moussa Hamadouche

MD, PhD

Cochin Hospital

入排标准

入选标准

•patients with primary or secondary osteoarthritis of the knee requiring total knee arthroplasty
•aged between 18 and 85 years
•able to understand information
•affiliated to social security.

排除标准

•active or suspected sepsis
•tumor around the knee
•previous partial or total knee replacement
•presence of hardware that could artifact MRI
•contraindication to MRI
•extra-articular deformation requiring osteotomy around the knee in conjunction with TKA
•social situation that could impair follow-up.

结局指标

主要结局

Mechanical axis

时间窗: 3 months

Lower limb mechanical axis was measured on a bipodal standing leg-length anteroposterior radiograph with the patella oriented straight made three months postoperatively, using Roman software version 1.70 (Oswestry, United Kingdom). Postoperative lower limb mechanical axis was calculated from the HKA (hip-knee-ankle) angle between the femoral and tibial mechanical axes, respectively. An HKA angle greater than 180° was indicative of valgus, whereas values lower than 180° indicated varus.