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

Peking University

Status: Completed

Conditions: Shoulder Dislocation

Treatments: Device: button plates fixation system; Device: Non-absorbable Suture Anchor

Study type: Interventional

Funder types: Other

Identifiers

NCT04960137

D2016052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Button Plates fixation system

Experimental group

Description:

Patients receiving surgery fixed with Button Plates fixation system

Treatment:

Device: button plates fixation system

Non-absorbable Suture Anchor

Active Comparator group

Description:

Patients receiving surgery fixed with Non-absorbable suture anchor

Treatment:

Device: Non-absorbable Suture Anchor