Accuracy of MRI-based Patients Matched Instruments and Jig-based Instruments in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- The alignment of mechanical axis after TKA
研究概览
简要总结
Total knee arthroplasty (TKA) is the common and effective procedure for treatment of end-staged knee osteoarthritis. Postoperative alignment of TKA is one of the important factors which effects on survival of prosthesis. High percentage of misalignment has been reported in conventional technique with using the jig based instruments. Several methods and devices were established to solve this problem. Customized or patient matched instruments were the novel technology that made from magnetic resonance imaging (MRI) of lower limb. With using special software to calculate the alignment axis, it was thought that accurate alignment can be achieved by using this instruments. Therefore, the study aimed to compare the accuracy of MRI based patient matched instruments and jig based instruments in TKA.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed primary osteoarthritis of knee and planned to undergo total knee arthroplasty
排除标准
- •Previous complex surgery of the affected knee
- •Metalic implant in the affected lower limb
- •Patients who unable or contraindicated to perform MRI
- •Extra-articular deformities of the affected lower limb
- •Extensive bone loss of distal femur or/and proximal tibia
- •More than 30 degrees of knee flexion contracture
- •Unable to perform TKA within 12 weeks after MRI
结局指标
主要结局
The alignment of mechanical axis after TKA
时间窗: Within 1 month after operation
次要结局
- The alignment of femoral and tibial components after TKA(Within 1 month after operation)