Prospective Analysis of Intraoperative AMNIOGEN® Injection in Patients With Rotator Cuff Tear
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 100 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed
研究概览
简要总结
Purpose: The purpose of this article is to examine the clinical application of AMNIOGEN® in patients with rotator cuff tear.
Methods:
The study was conducted on 100 adult participants with age over affected by unilateral shoulder rotator cuff tear and receiving RCT repair. The investigators divided the participants in two groups, and the group A was treated with perioperative injection of AMNIOGEN® A, group B with perioperative normal saline.
Follow-up:
Every 1,3,and 12months, the investigators recheck physical exmianation at OPD and recheck MRI at postoperative 3 months.
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 (Participant)
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
- •receiving unilateral shoulder RCT repair in our hospital postoperative follow-up over 3 month
排除标准
- •postoperative follow-up less than 3 month possible pregnency with coagulation disease NSAIDs intake during study period
研究组 & 干预措施
AMNIOGEN
Intraoperative1 kit of AMNIOGEN injection into shoulder joint after RCT repair.
干预措施: AMNIOGEN (Drug)
Normal saline
Intraoperative 10 ml of normal saline injection into shoulder joint after RCT repair.
干预措施: normal saline (Other)
结局指标
主要结局
100 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed
时间窗: postoperative 3 month
size and site of rotator cuff tear was accessed by MRI T1 and T2 image; MRI was checked by one orthopedist
100 of participants with preoperative and postoperative physical examination are accessed by Empty can test
时间窗: postoperative 12 month
the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist
次要结局
未报告次要终点
研究者
Yi Ping Wei
Orthopaedic
Kaohsiung Veterans General Hospital.