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

Shoulder Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04960137
• Other study ID #: D2016052
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

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.
• Non-absorbable Suture Anchor
A conventional device used in surgery for shoulder dislocation.

Locations

Country	Name	City	State
China	PekingUTH	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University Third Hospital	Hunan People's Hospital, The First Hispital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rowe score	The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.	before surgery
Primary	Rowe score	The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.	3 months after surgery
Primary	Rowe score	The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.	6 months after surgery
Secondary	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
Secondary	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
Secondary	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