Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non-randomized Controlled Study of Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor

Conditions
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Shoulder Dislocation

Intervention / Treatment
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* Device: button plates fixation system
* Device: Non-absorbable Suture Anchor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a glenoid defect ≥10% contact sport athletes with a glenoid defect < 10% failure after Bankart repair. Exclusion Criteria: epilepsy 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Button Plates fixation system<br>Patients receiving surgery fixed with Button Plates fixation system | Device: button plates fixation system<br>* The button plates fixation system consists of fixing plate, prefabricated mix, button and fuse. In the process of use, the fuse plays the role of guiding the fixed plate through, pulling the button and shortening the distance between the button and the fixed plate. The prefabricated mix is pre-worn between the button and the fixed plate, and the lead pulls the distance between the fixed plate and the button after tightening and fixing. Prefabricated mix, make mix tight and knot. Finish the preliminary work of fixing.<br>|
| Active Comparator: Non-absorbable Suture Anchor<br>Patients receiving surgery fixed with Non-absorbable suture anchor | Device: Non-absorbable Suture Anchor<br>* A conventional device used in surgery for shoulder dislocation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rowe score | The Rowe score is an internationally recognized scoring system for the assessment of shoulder function. | before surgery | 
| Rowe score | The Rowe score is an internationally recognized scoring system for the assessment of shoulder function. | 3 months after surgery | 
| Rowe score | The Rowe score is an internationally recognized scoring system for the assessment of shoulder function. | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASES score | The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints. | before surgery | 
| ASES score | The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints. | 3 months after surgery | 
| ASES score | The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints. | 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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button, non-absorbable suture anchor