Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma. Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Comparison of re-tear rates between groups.
研究概览
简要总结
Purpose: To assess whether the use of platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair. Hypothesis: Platelet rich plasma used as an adjuvant to arthroscopic rotator cuff repairs decrease the rate of retears.
详细描述
Platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 50 and 75 years with a defined complete rotator cuff tear as compatible clinical and confirmation by magnetic resonance imaging (MRI).
- •Minimum of 3 months of failed conservative treatment (anti-inflammatory, physical therapy and infiltration with corticosteroids)
排除标准
- •Refusal to participate or informed consent,
- •Revision surgery,
- •Partial repair,
- •Patients with shoulder osteoarthritis> 2
- •Advanced fat infiltration of the rotator cuff muscles (STAGE 3 or 4)
- •Systemic or rheumatoid arthritis,
- •Uncontrolled diabetes, (patients for whom surgery is contraindicated in the preoperative evaluation by the clinician and anesthesiologist)
- •Acute or chronic infections of the shoulder to be operated on
- •Ongoing cancer chemotherapy therapies
- •Sepsis, septic arthritis, osteomyelitis or other ongoing infectious processes;
- •Previous operations on the affected shoulder,
- •Patients with autoimmune diseases;
结局指标
主要结局
Comparison of re-tear rates between groups.
时间窗: 6 months
Postoperative MRI to assess the structural integrity of the repaired rotator cuff.
次要结局
- Number of Participants With Treatment-Related Adverse Events(3, 6, and 12 months)
- Change From baseline in shoulder functional scores at 3, 6 and 12 months(baseline, 3, 6, and 12 months)
- Change From baseline in pain at 3, 6 and 12 months(baseline, 3, 6, and 12 months)
研究者
LUCIANO ANDRES ROSSI
Pincipal investigator
Hospital Italiano de Buenos Aires