Non-randomized Controlled Study of Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Shoulder Dislocation
- Sponsor
- Peking University Third Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Rowe score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a glenoid defect ≥10%
- •contact sport athletes with a glenoid defect \< 10%
- •failure after Bankart repair.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Rowe score
Time Frame: 6 months after surgery
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Secondary Outcomes
- ASES score(6 months after surgery)