The Evaluation of Cascade PRFM on Rotator Cuff Healing
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- L'Insalata: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively
研究概览
简要总结
Hypothesis: The use of cascade platelet-rich fibrin matrix (PRFM) on medium and large sized rotator cuff tears will improve patient results versus the control results by 50%.
The purpose of this study is to examine the effect of PRFM on rotator cuff repairs. Since locally applied platelet-derived growth factor (PDGF) has shown early promise in enhancing tendon and ligament healing in anterior cruciate ligament (ACL) and medial collateral ligament (MCL) reconstruction, the investigators believe that locally applied PRFM will enhance the quality of rotator cuff repairs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 45 years of age and older who have failed conservative treatment for rotator cuff pathology.
- •Patients in this study will have full thickness rotator cuff tears that are classified arthroscopically as medium (1 to 3 cm) or large (3 to 5 cm) and that are treated with arthroscopic repair.
排除标准
- •Patients who have undergone revision procedures, mini-open, or open procedures will be excluded.
结局指标
主要结局
L'Insalata: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively
American Shoulder and Elbow Surgery (ASES) Patient Survey: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively
次要结局
- Ultrasound (power Doppler imaging): 6 weeks, 3 months post-operatively
- Manual muscle testing using a dynamometer: preoperatively, 3 months post-operatively, 6 months post-operatively
- ASES Physician Survey: preoperatively, 3 months post-operatively, 12 months post-operatively