Synovectomy Versus no Synovectomy in Primary Total Knee Arthrplasty : A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Health related quality of life e.g. short form (SF12) scale
研究概览
简要总结
The aim of total knee arthroplasty is to achieve best patient functional outcomes, improve patient pain score and satisfaction. Synovial proliferation is a common finding in arthritic knees. Surgeons can't decide if synovectomy is a crucial step in the operation. Studies didn't prove the clear benefits of synovectomy. We are aiming to perform a randomized clinical trial trying to reach the best evidence in that matter.
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 (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with primary osteoarthritis undergoing primary total knee arthroplasty
排除标准
- •Inflammatory arthritis
- •Revision knee arthroplasty
研究组 & 干预措施
Synovectomy
干预措施: Synovectomy (Other)
No synovectomy
结局指标
主要结局
Health related quality of life e.g. short form (SF12) scale
时间窗: one year
Reoperation rate
时间窗: one year
Range of motion
时间窗: One year
knee pain e.g. visual analogue score (VAS) score
时间窗: immediate postoperative
Functional outcome scores. e.g. knee society score (KSS)
时间窗: one year
Revision rate
时间窗: one year
次要结局
- Wound complications(in first 3 months)
- Postoperative hemoglobin level(immediate postoperative)
- Postoperative blood loss(immediate postoperative)
- Number of patients requiring transfusion(immediate postoperative)
- Infection rate(in first three month)
研究者
Ahmed Saeed Younis
Principle investigator
Ain Shams University