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

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04960137
• Collaborator: Hunan People's Hospital (Other), The First Hispital of Jilin University (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.9
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Dislocation	Device: button plates fixation system; Device: Non-absorbable Suture Anchor	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Non-randomized Controlled Study of Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor
• Actual Study Start Date: Sep 1, 2017
• Actual Primary Completion Date: Sep 30, 2018
• Actual Study Completion Date: Feb 28, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Rowe score [before surgery]

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

2. Rowe score [3 months after surgery]

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

3. Rowe score [6 months after surgery]

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

Secondary Outcome Measures

1. ASES score [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PekingUTH	Beijing	Beijing	China

Sponsors and Collaborators

• Peking University Third Hospital
• Hunan People's Hospital
• The First Hispital of Jilin University

Investigators

• Study Chair: Guoqing Cui, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04960137
• Other Study ID Numbers: D2016052
• First Posted: Jul 13, 2021
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peking University Third Hospital: button; non-absorbable suture anchor
• Additional relevant MeSH terms: Joint Dislocations; Shoulder Dislocation

Study Results

No Results Posted as of Jul 21, 2021