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

Not Applicable

Completed

• Conditions: Shoulder Dislocation
• Interventions: Device: button plates fixation system; Device: Non-absorbable Suture Anchor

• Registration Number: NCT04960137
• Lead Sponsor: Peking University Third Hospital

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 Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-09-30
• Study Completion: 2019-02-28
• Status Verified: 2021-07
• Study First Submitted: 2021-07-04
• Study First Submitted QC: 2021-07-04
• Study First Posted: 2021-07-13
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. a glenoid defect ≥10%
2. contact sport athletes with a glenoid defect < 10%
3. failure after Bankart repair.

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Exclusion Criteria

1. epilepsy
2. multidirectional shoulder instability
3. concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps
4. Follow-up was less than 2 years or incomplete follow-up data.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Button Plates fixation system	button plates fixation system	Patients receiving surgery fixed with Button Plates fixation system
Non-absorbable Suture Anchor	Non-absorbable Suture Anchor	Patients receiving surgery fixed with Non-absorbable suture anchor

Primary Outcome Measures

Name	Time	Method
Rowe score	6 months after surgery	The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.

Secondary Outcome Measures

Name	Time	Method
ASES score	6 months after surgery	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.

Trial Locations

Locations (1)

PekingUTH; 🇨🇳 Beijing, Beijing, China