Primary TKA Using a Fully Disposable Patient-Specific Instrumentation: A Multicenter Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 主要终点
- HKA angle
研究概览
简要总结
To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with fully disposable patient-specific instrumentation versus conventional, versus patient specific instrumentation.
详细描述
The investigators performed a controlled multicenter trial comparing the clinical and radiologic results and resources consumption of primary TKA using patient-specific cutting guides (PSCG) versus conventional instrumentation (CI), and compared the results to those obtained with a fully disposable patient-specific instrumentation (PSCG-D).
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 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
- •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
HKA angle
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 Hip-Knee-Ankle (HKA) 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
- Knee Society Score(3 months)
- % outliers(3 months)
- Oxford Knee Score(3 months)
研究者
Moussa Hamadouche
MD, PhD, Professor of Orthopaedic Surgery
Cochin Hospital