Effect of Postoperative Immobilization on Healing After Rotator Cuff Arthroscopic Repair With Double Row Technique in Small or Medium Ruptures. Prospective, Comparative and Randomized.
试验速览
- 阶段
- 不适用
- 入组人数
- 114
- 试验地点
- 1
- 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
研究组 & 干预措施
Early passive motion
Pendulum exercises starting on the first postoperative day. The patients are instructed to commence passive range-of-motion exercises in the plane of the scapula with the assistance with the contralateral limb. Active motion exercises were not permitted until four weeks after surgery.
干预措施: Postoperative early passive motion (Procedure)
Immobilization
Immobilization with sling during a month. Pendulum exercises starting on the fourth postoperative week. The patients are instructed to commence passive range-of-motion exercises in the plane of the scapula with the assistance with the contralateral limb. Active motion exercises.
干预措施: Sling (Other)
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