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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedFirst Submitted
Initial submission to the registry
July 4, 2021
CompletedFirst Posted
Study publicly available on registry
July 13, 2021
CompletedJuly 21, 2021
July 1, 2021
1.1 years
July 4, 2021
July 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
ASES score
before surgery
ASES score
3 months after surgery
ASES score
6 months after surgery
Study Arms (2)
Button Plates fixation system
EXPERIMENTALPatients receiving surgery fixed with Button Plates fixation system
Non-absorbable Suture Anchor
ACTIVE COMPARATORPatients receiving surgery fixed with Non-absorbable suture anchor
Interventions
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.
A conventional device used in surgery for shoulder dislocation.
Eligibility Criteria
You may qualify if:
- a glenoid defect ≥10%
- contact sport athletes with a glenoid defect \< 10%
- failure after Bankart repair.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking University Third Hospitallead
- Hunan People's Hospitalcollaborator
- The First Hospital of Jilin Universitycollaborator
Study Sites (1)
PekingUTH
Beijing, Beijing Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guoqing Cui
Peking University Third Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2021
First Posted
July 13, 2021
Study Start
September 1, 2017
Primary Completion
September 30, 2018
Study Completion
February 28, 2019
Last Updated
July 21, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share