NCT04587037Unknown不适用
A Clinical Study Comparing Superior Capsule Reconstruction Using Fascia Lata Allograft With Human Dermal Allograft for Irreparable Rotator Cuff Tear
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 主要终点
- American Shoulder and Elbow Surgeons (ASES) score
研究概览
简要总结
Biomechanical and clinical success of the superior capsule reconstruction (SCR) using fascia lata (FL) grafts has been reported in treating irreparable rotator cuff tear. Human dermal (HD) allograft has been used successfully for SCRs; however, the clinical comparative study between FL and HD have not been reported.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with irreparable rotator cuff tears
- •Underwent superior capsule reconstruction using fascia lata allograft with human dermal allograft
- •At least two years follow-up
排除标准
- •reparable rotator cuff tears
- •underwent partial repair or reverse total shoulder arthroplasty
研究组 & 干预措施
Fascia lata group
Experimental
干预措施: fascia lata allograft (Procedure)
Dermal allograft group
Experimental
干预措施: human dermal allograft (Procedure)
结局指标
主要结局
American Shoulder and Elbow Surgeons (ASES) score
时间窗: 2 year postoperatively
A patient-reported outcome measurement
Retear rate
时间窗: 1 year postoperatively
Measured in MRI
Acromiohumeral distance (AHD)
时间窗: 1 year postoperatively
measured in X-ray
次要结局
未报告次要终点
研究者
Chunyan Jiang
Director of Sports Medicine Service of Beijing Jishuitan hospital
Beijing Jishuitan Hospital
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