Effect of Polydeoxyribonucleotide (PDRN) on Healing and Fatty Degeneration of Rotator Cuff in Human
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- American Shoulder and Elbow score
研究概览
简要总结
This study is to evaluate the effect of polydeoxyribonucleotide (PDRN) for healing and fatty degeneration of rotator cuff. The investigators will enroll 130 patients with rotator cuff tear who will undergo arthroscopic rotator cuff repair. 130 patients will be classified into two group. One group (PDRN) will be injected at the repaired cuff with 3cc polydeoxyribonucleotide just after surgery and be injected with another 3ml polydeoxyribonucleotide under ultrasound guidance 2 weeks after the surgery. The other group (CONTROL) will be injected with 3ml normal saline in the same manner.
详细描述
Polydeoxyribonucleotide is a tissue regeneration activator. It binds an adenosine receptor and stimulate VEGF(vascular endothelial growth factor) synthesis and stimulate collagen synthesis. Nowadays, a lot of arthroscopic rotator cuff repairs are being performed. but the failure rate of rotator cuff repair is considerably high. Therefore, this study is to evaluate the effect of polydeoxyribonucleotide for healing and fatty degeneration of rotator cuff.
Visual analog scale (VAS) of pain and other functional scores of the two group will be checked preoperatively and postoperative 3, 6, 12, 24 months. Growth factors (VEGF, fibroblast growth factor(FGF), insulin like growth factor(IGF)) will be checked preoperatively and postoperative 1h, 2 days, 2 weeks, 6 weeks, 3, 6 months. Follow up MRI will be checked at postoperative 6 months. The parameters will be compared using statistical analysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
79 participants with rotator cuff tear will be randomly assigned to PDRN or CONTROL depending on the injection material. Randomization will be performed with a computerized random-sequence generator by an independent nurse.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •definite rotator cuff tear on preoperative MRI, which needs repair
- •acceptance of arthroscopic surgery including rotator cuff repair
排除标准
- •history of ipsilateral shoulder operation or fracture
- •concomitant neurological disorder around the
研究组 & 干预措施
PDRN(polydeoxyribonucleotide)
polydeoxyribonucleotide 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance
干预措施: Polydeoxyribonucleotides (Drug)
CONTROL(normal saline)
normal saline 3cc at surgery under arthroscopy guidance and 2 weeks after surgery under ultrasound guidance
干预措施: Normal saline (Drug)
结局指标
主要结局
American Shoulder and Elbow score
时间窗: 2 years
functional score of shoulder between 0 to 100(0: bad, 100: good)
次要结局
- Constant score(2 years)
研究者
Jung-Taek Hwang
Associate Professor
Chuncheon Sacred Heart Hospital