RCT Multicenter Comparison of Patient-Specific Versus Conventional Instrumentation in Primary TKA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Mechanical axis
研究概览
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.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
研究组 & 干预措施
Conventional
Conventional instrumentation
干预措施: Conventional instrumentation (Device)
PSI
Patient specific instrumentation
干预措施: PSI (Device)
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.
次要结局
- Components position(3 months)