Non-randomized Controlled Study of Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Rowe score
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Button Plates fixation system
Patients receiving surgery fixed with Button Plates fixation system
Intervention: button plates fixation system (Device)
Non-absorbable Suture Anchor
Patients receiving surgery fixed with Non-absorbable suture anchor
Intervention: Non-absorbable Suture Anchor (Device)
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.
Rowe score
Time Frame: before surgery
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Rowe score
Time Frame: 3 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)
- ASES score(before surgery)
- ASES score(3 months after surgery)