NCT03061942已完成不适用
Arthroscopic Rotator Cuff Repair With Synovectomy; Prospective Randomized Controlled Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The worst pain VAS(visual analogue scale)
研究概览
简要总结
The purpose of this study is to assess the effect of synovectomy on clinical outcomes of arthroscopic rotator cuff 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a full-thickness rotator cuff tear undergoing arthroscopic rotator cuff repair
排除标准
- •History of shoulder surgery
- •Acute trauma on affected shoulder
- •Chronic dislocation
- •Pyogenic infection
- •Rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head
- •Isolated subscapularis tear
- •Psychiatric problems that precluded informed consent
- •An inability to read or write
- •Other serious issues that precluded participation in the study
- •Open surgery
- •Rotator cuff tear with worker's compensation claim
- •Refuse to participate in the study
- •LOM that need brisement force
- •Partial-thickness tear with focal full-thickness extension
- •Irrepairable rotator cuff tear
- •Subjects who, for any reason, are judged by the investigator to be inappropriate for this study, including a subject who had other severe medical condition or laboratory abnormality, or who is unable to communicate or to cooperate with the investigator
研究组 & 干预措施
Conventional
Active Comparator
Arthroscopic rotator cuff repair without synovectomy
干预措施: Arthroscopic rotator cuff repair without synovectomy (Other)
Synovectomy
Experimental
Arthroscopic rotator cuff repair with synovectomy
干预措施: Arthroscopic rotator cuff repair with synovectomy (Other)
结局指标
主要结局
The worst pain VAS(visual analogue scale)
时间窗: at 3 months after surgery
A 10-cm scale marked from ''no pain''(0) to ''unbearable pain''(10) was used.
次要结局
- The average pain VAS(visual analogue scale)(at 3 months after surgery)
- Constant-Murley score(at 3 months after surgery)
研究者
Hyunchul Jo
Associate professor
Seoul National University Hospital
研究点 (1)
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