NCT05624164招募中不适用
Randomized Controlled Trial of Patients Treated With and Without Lateralized Microfracture During Rotator Cuff Repair
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Magnetic Resonance Imaging (MRI)
研究概览
简要总结
The goal of this clinical trial is to test whether there is any effect on rotator cuff healing by making microfracture at the lateral side of the footprint. The main question it aims to answer are:
- [whether the lateralized microfracture could decrease the retear rate after arthroscopy rotator cuff repair.]
- [whether the lateralized microfracture could improve the functional recovery after arthroscopy rotator cuff repair.] Participants with medium to larger size rotator cuff tears will be randomly assigned to the study group treated with lateralized microfracture immediately after arthroscopy rotator cuff repair or the control group treated with conventional arthroscopy rotator cuff repair without microfracture.
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
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medium to large Rotator cuff tear(1cm-5cm) diagnosed by MRI
- •Patients can complete the follow-up and comply with all post-operative rehab instructions
- •Failure of non-operative treatment for at least 3 months
排除标准
- •Revision rotator cuff surgery
- •Partial thickness rotator cuff tears
- •Small (less than 1cm) and Massive (greater than 5cm) rotator cuff tears
- •Disease history of the affected shoulder
- •Systemic immune diseases
- •Irreparable rotator cuff tear
结局指标
主要结局
Magnetic Resonance Imaging (MRI)
时间窗: 24 months postoperative
The scans were evaluated for rotator cuff integrity and degree of re-tears (no re-tears, partial or complete re-tear) by an independent radiologist
次要结局
- American Shoulder and Elbow Score(Preoperative, 3 months and 24 months postoperative)
- University at California at Los Angeles Shouder Rating Scale(Preoperative, 3 months and 24 months postoperative)
- Visual Analog Scale for Pain(Preoperative, 3 months and 24 months postoperative)
- Passive range of motion of Shoulder(Preoperative, 3 months and 24 months postoperative)
- Active range of motion of Shoulder(Preoperative, 3 months and 24 months postoperative)
研究者
研究点 (2)
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