The Contribution of Platelet-Rich Plasma to the Surgical Treatment of Rotator Cuff Tear: An Experimental Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change from baseline of Constant - Murley score
研究概览
简要总结
Purpose of the study:
The aim of the study is to determine whether the postoperative administration of biological therapy with autologous platelet-rich plasma improves the clinical, imaging, and biochemical outcomes following surgical repair of a shoulder rotator cuff tear.
What does the study involve? The study involves the postoperative administration of biological therapy after blood is drawn from the patients and processed appropriately. All patients will also undergo the necessary laboratory and imaging preoperative assessments, the surgical procedure, and standard postoperative rehabilitation, as routinely performed at this center. Tissue samples may be collected intraoperatively for testing. Postoperative follow-up will include clinical evaluations at specific time points-before surgery and at 1 month (regarding pain), 3 months, 6 months, and 1 year after therapy administration. At 6 months post-treatment, patients will undergo a follow-up MRI scan.
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
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients enrolled had symptomatic rotator cuff tears, which were confirmed by magnetic resonance imaging (MRI). They had failed previous conservative management and physical therapy of at least 3 months and were candidates for surgical treatment.
排除标准
- •a) acute shoulder trauma, (b) any history of a previous surgical operation on their shoulder, (c) the local administration of corticosteroids up to fifteen days before the operation or systemic administration of corticosteroids up to a month before the operation, (d) the use of non-steroidal anti-inflammatory drugs during the trial, (e) any signs of infection or systematic inflammatory disease for at least fifteen days before the operation, (f) history of malignancy or chemotherapy during the previous year, (g) rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head, (h) pregnancy or breastfeeding, and in case of any of these conditions the patients where ultimately excluded from the trial results.
结局指标
主要结局
Change from baseline of Constant - Murley score
时间窗: at 3, 6 and 12 months postoperatively
Change from baseline of ASES score
时间窗: at 3, 6 and 12 months postoperatively
次要结局
- Rate of shoulder rotator cuff tendon retears(at 6 months postoperatively)
- Measurement of pain on a Numerical Rating Scale (NRS) of 0 to 15(at 1 month postoperatively)
研究者
Ioannis Angelos Trantos
Ioannis Angelos Trantos, MD, MSc
KAT General Hospital