Achilles Tendon Homograft for the Treatment of Gluteus Medius Insufficiency After Hip Replacement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Oxford Hip Score (OHS)
研究概览
简要总结
Residual limping after total hip arthroplasty is a serious complication that lacks effective treatment. The purpose of this study is to evaluate a surgical treatment for residual limping and compare its results with non-surgical treatment. Our hypothesis is that surgical treatment followed by physiotherapy increases hip function and reduces limping compared with non-surgical treatment with physiotherapy alone.
详细描述
Residual limping due to gluteus medius insufficiency after total hip arthroplasty is a serious complication that lacks effective treatment. The purpose of this study is to evaluate surgical reconstruction of gluteus medius using Achilles tendon allograft and compare its results and adverse events with non-surgical treatment. Our hypothesis is that surgical reconstruction followed by physiotherapy increases hip function and reduces limping compared with non-surgical treatment with physiotherapy alone.
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persisting limping with positive Trendelenburg's sign for at least 12 months after total hip arthroplasty
- •Rupture/avulsion of the gluteus medius tendon verified with ultrasound or MRI
- •Leg length discrepancy of less than 1 cm
- •Femoral offset discrepancy of less than 25%
排除标准
- •Neuromuscular disorders
结局指标
主要结局
Oxford Hip Score (OHS)
时间窗: 12 months
Patient-reported hip function measured in a scale 0-48
次要结局
- University of California Level of Activity (UCLA)(12 months)
- Euroqol 5 dimension 5 level index (EQ5D-5L)(12 months)
- Euroqol visual analog scale (EQVAS)(12 months)
- Adverse events(12 months)
- Trendelenburg's sign(12 months)
- Hip abduction torque(12 months)
研究者
Georgios Tsikandylakis, MD PhD
Senior consultant in orthopaedic surgery
Sahlgrenska University Hospital