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

Peking University Third Hospital100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Shoulder Dislocation

Interventions

button plates fixation systemDEVICE

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 AnchorDEVICE

A conventional device used in surgery for shoulder dislocation.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

PekingUTH

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Rowe score

The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.

Time frame: before surgery

Rowe score

The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.

Time frame: 3 months after surgery

Rowe score

The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.

Time frame: 6 months after surgery

Secondary Outcomes

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.

Time frame: before surgery

ASES score

Time frame: 3 months after surgery

ASES score

Time frame: 6 months after surgery

Data from ClinicalTrials.gov

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