NCT01458665已完成不适用
Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma (PRP) in Medium to Large Rotator Cuff Tears: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Constant-Murley shoulder score
研究概览
简要总结
- The purpose of this study is to compare the clinical and anatomical outcomes of rotator cuff repair with Platelet-Rich Plasma (PRP) and conventional rotator cuff repair in treatment of medium to large rotator cuff tears.
- PRP application to arthroscopic rotator cuff repair would accelerate recovery after arthroscopic rotator cuff repair in terms of pain relief, functional outcomes, overall satisfaction, and enhance structural integrity of repaired tendon.
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
- •medium to large rotator cuff tear as a determined by clinical examination and MR prior to surgery.
排除标准
- •previous history of shoulder surgery
- •acute trauma
- •chronic dislocation
- •pyogenic infection
- •rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head
- •showed abnormal serological test results
- •thrombocytopenia (platelets less than 15000 per microliter)
- •had been received anti-platelet medication
- •psychiatric problems that precludes informed consent or inability to read or write
- •other serious problems that preclude participation of the study
研究组 & 干预措施
PRP group
Experimental
干预措施: Arthroscopic rotator cuff repair with PRP (Procedure)
Conventional group
Placebo Comparator
干预措施: Conventional arthroscopic rotator cuff repair (Procedure)
结局指标
主要结局
Constant-Murley shoulder score
时间窗: Postoperative 3months
The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100.
次要结局
未报告次要终点
研究者
Hyunchul Jo
Assistant Professor, SMG-SNU Boramae Medical Center
Seoul National University Hospital
研究点 (1)
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