The Difference of Angle of Femoral Component Rotation in TKA With Gap Balance and Measured Resection Technique
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- femoral component rotation
研究概览
简要总结
Gap balance type and measured resection type total knee arthroplasty (TKA) have different influence on the rotation of femoral component.In this study, the rotation of patients received different type of TKA will be estimated and analysed through preoperation and postoperation knee joint CT scan.
详细描述
This is a multicenter, double-blined, randomized controled clinical trial. 98 patients from 2 clinical center will be recruited with primary knee osteoarthritis, undergoing a primary TKA. The patients will be randomly divided into two groups , the measured resection group and the gap balance group.And the gap balance technique in this study will be achieved with a ligament tensor used during TKA. Femoral component rotation will be assessed from the preoperative and postoperative CT scans.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe primary osteoarthritis patients over 65 years old No obvious surgical contraindications
排除标准
- •There are surgical contraindications Varus or valgus alignment exceeds 20 degrees
研究组 & 干预措施
gap balance group
The type of total knee arthroplasty will be the balance gap.The gap balance type of total knee arthroplasty will be performed.
干预措施: the gap balance type of total knee arthroplasty (Procedure)
measured resection group
The type of total knee arthroplasty will be the measured resection.The measured resection type of total knee arthroplasty will be performed.
干预措施: the measured resection type of total knee arthroplasty (Procedure)
结局指标
主要结局
femoral component rotation
时间窗: 6 weeks after the surgery
The change of femoral component will be assessed through preoperation as well as postoperation CT scan for knee joint.
次要结局
未报告次要终点
研究者
chenyifan
arthritis clinic and research center
Peking University People's Hospital