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

Non-randomized Controlled Study of 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.

Study Overview

• Status: Completed
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Device: button plates fixation system; Device: Non-absorbable Suture Anchor

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • PekingUTH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Button Plates fixation system; Patients receiving surgery fixed with Button Plates fixation system	Device: 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.
Active Comparator: Non-absorbable Suture Anchor; Patients receiving surgery fixed with Non-absorbable suture anchor	Device: Non-absorbable Suture Anchor; A conventional device used in surgery for shoulder dislocation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rowe score	The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.	before surgery
Rowe score	The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.	3 months after surgery
Rowe score	The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before surgery
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.	3 months after surgery
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.	6 months after surgery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Hunan People's Hospital; The First Hispital of Jilin University
• Investigators: Study Chair: Guoqing Cui, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: button; non-absorbable suture anchor
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: D2016052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No