NCT01502098Unknown不适用
Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair With Double Row Technique in Small or Medium Ruptures. Prospective, Comparative and Randomized.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- MRI
研究概览
简要总结
The study aims to establish whether one month postoperative immobilization compared early passive motion after rotator cuff arthroscopic repair in small or medium ruptures with double row technique has any healing significance.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients skeletally mature (older 18 years old)
- •Small or medium rupture of rotator cuff
- •Repaired with arthroscopic double row technique
排除标准
- •Impossibility to perform MRI (claustrophobic, pacemaker, heart or brain metallic implants)
- •AC arthritis with mumford procedure
- •Postoperative complication (severe pain, thrombosis, infection)
- •Psychiatric disorder
结局指标
主要结局
MRI
时间窗: 6 months
次要结局
- ASES (American Shoulder and Elbow Surgeons Subjective Shoulder Scale)(1, 3, 6 months)
- Range of Motion(1, 3, 6 months)
- VAS of pain(1, 3, 6 months)
- WORC(1, 3, 6 months)
研究者
Lopez Ovenza Juan Manuel
Principal Investigator
Hospital Italiano de Buenos Aires
研究点 (2)
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