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Completed

NCT Number: NCT04960137

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

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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Key information

Conditions

Shoulder Dislocation Joint Diseases Joint Dislocations Musculoskeletal Diseases Shoulder Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PekingUTH

Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

button plates fixation system

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

Device

A conventional device used in surgery for shoulder dislocation.

Primary outcomes

  1. Rowe score

    Time frame: before surgery

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

  2. Rowe score

    Time frame: 3 months after surgery

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

  3. Rowe score

    Time frame: 6 months after surgery

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

Secondary outcomes

  1. ASES score

    Time frame: before 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.

  2. ASES score

    Time frame: 3 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.

  3. ASES score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Hunan People's Hospital
  • The First Hospital of Jilin University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 13, 2021
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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