Non-randomized Controlled Study of Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rowe score
研究概览
简要总结
The purpose of this study is to conduct a comparative study through clinical trials to verify the safety and efficacy of the products in the experimental group for clinical use.
详细描述
The product of this clinical validation is the fixed button plate system, which is used for the reconstruction of the coracoclavicular ligament in the treatment of recurrent shoulder dislocation. The clinical trial was conducted to verify the rationality of its structural design, the convenience of its operation, and the effectiveness and safety of its clinical use. This trial was conducted in a parallel controlled trial design, the patients were divided into test and control groups to evaluate the safety and efficacy of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a glenoid defect ≥10%
- •contact sport athletes with a glenoid defect < 10%
- •failure after Bankart repair.
排除标准
- •multidirectional shoulder instability
- •concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps
- •Follow-up was less than 2 years or incomplete follow-up data.
研究组 & 干预措施
Button Plates fixation system
Patients receiving surgery fixed with Button Plates fixation system
干预措施: button plates fixation system (Device)
Non-absorbable Suture Anchor
Patients receiving surgery fixed with Non-absorbable suture anchor
干预措施: Non-absorbable Suture Anchor (Device)
结局指标
主要结局
Rowe score
时间窗: 6 months after surgery
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Rowe score
时间窗: before surgery
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Rowe score
时间窗: 3 months after surgery
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
次要结局
- ASES score(6 months after surgery)
- ASES score(before surgery)
- ASES score(3 months after surgery)