Double Blind Prospective Randomize Trail of Partial Tear of SSP and Treatment With PRGF
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- partial tear of supraspinatus tendon
研究概览
简要总结
The objective of this clinical trial is to evaluate the impact and symptomatic efficacy of platelets rich plasma (PRP \ PRGF) in the treatment of partial tears of supraspinatus tendon of rotator cuff.
Speed of tendon healing of partial thickness tear of the supraspinatus tendon influenced by local injection of platelets rich plasma
详细描述
Primary endpoint: evaluate functional changes after treatment with local infection with platelets rich plasma. This functional changes will be evaluate with Constant Score (questionnaire of shoulder function) and clinical examination.
Secondary endpoint: evaluate the healing effect of the platelets rich plasma locally injected on partial tear of SSP tendon. These morphologic changes will be evaluated by echography
Selection and withdrawal of subjects 40 patients with partial tear of supraspinatus tendon diagnosed by echography. INCLUSION CRITERIA Male or female patients aged between 18 and 60 Patients suffering from partial tear of supraspinatus tendon on echography. Patients who are willing to participate in the trial, to come to all scheduled visits and to sign the informed consent forms.
EXCLUSION CRITERIA Patients receiving other methods of treatment to this area, who had concomitant other injury of the Rotator Cuff tendons.
Non cooperative patient with the basic rehab program.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 18 and 60
- •Patients suffering from partial tear of supraspinatus tendon on echography.
- •Patients who are willing to participate in the trial, to come to all scheduled visits and to sign the informed consent forms.
排除标准
- •Patients receiving other methods of treatment to this area, who had concomitant other injury of the Rotator Cuff tendons.
- •Non cooperative patient with the basic rehab program.
结局指标
主要结局
partial tear of supraspinatus tendon
时间窗: one year
次要结局
- efficacy of platelets rich plasma (PRP \ PRGF)(one year)