Platelet-Rich Fibrin for Arthroscopically Repaired Massive Rotator Cuff Tears: A Prospective Randomized Pilot Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI
研究概览
简要总结
The objective of this study was to prospectively evaluate the influence of local application of Platelet Rich Fibrin (PRF) on the functional outcome and integrity of the arthroscopically repaired tendons in patients with massive tears of the rotator cuff.
详细描述
A prospective, randomized clinical trial was performed on 28 patients (22 females, 6 males) with an average age of 65 years (range, 53 to 77) undergoing complete arthroscopic repair of a massive rotator cuff tear. In 14 patients, after the repair was completed, 6 cc. of PRF (vivostat ®) were locally applied to the repair site. In 14 patients no addition of PRF was performed. All patients underwent an arthro-MRI to evaluate the integrity of the repair and a clinical exam one year after the operation. All patients were then followed clinically at a minimum of 2 years. Functional outcome was evaluated with the Constant and DASH scores.
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 (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Massive rotator cuff tears affecting supraspinatus and infraspinatus
- •Failed conservative treatment for at least 6 months
- •No hematologic disorder
排除标准
- •Rotator cuff affecting subscapularis
- •chronic infectious disease
- •clot disorders
- •low platelet count
- •history of difficulty in venous puncture
结局指标
主要结局
rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI
时间窗: one year
次要结局
- functional outcome evaluated with constant score(two years)
- disability outcome evaluated with dash score(two years)
研究者
Samuel Antuna
Consultant in Shoulder and Elbow Surgery
Hospital Universitario La Paz