Arthroscopic Rotator Cuff Repair With Platelet-Rich Plasma(PRP) in Large to Massive Tears : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- structural integrity of repaired rotator cuff tendon
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 large to massive 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
- •large to massive 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
结局指标
主要结局
structural integrity of repaired rotator cuff tendon
时间窗: postoperative 9months
To evaluate structural outcomes, magnetic resonance(MR)imaging or computed tomography arthrography were used at minimum postoperative 9months. The structural integrity was evaluated using Sugaya's method; * type I, sufficient thickness with homogenously low intensity * type II, insufficient thickness partial high intensity * type III, insufficient thickness without discontinuity (thinned cuff) * type IV, presence of minor discontinuity * type V, presence of a major discontinuity Type I, II, and III were considered as healed, while type IV, and V were considered as retear.
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