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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-02-28

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.

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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.

Conditions

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Shoulder Dislocation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Button Plates fixation system

Patients receiving surgery fixed with Button Plates fixation system

Group Type EXPERIMENTAL

button plates fixation system

Intervention Type DEVICE

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.

Non-absorbable Suture Anchor

Patients receiving surgery fixed with Non-absorbable suture anchor

Group Type ACTIVE_COMPARATOR

Non-absorbable Suture Anchor

Intervention Type DEVICE

A conventional device used in surgery for shoulder dislocation.

Interventions

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button plates fixation system

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.

Intervention Type DEVICE

Non-absorbable Suture Anchor

A conventional device used in surgery for shoulder dislocation.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No