Shoulder DislocationNCT04960137
Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor
A study testing button plates fixation system and Non-absorbable Suture Anchor in people with Shoulder Dislocation, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- button plates fixation system and Non-absorbable Suture Anchor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a glenoid defect ≥10%
- contact sport athletes with a glenoid defect < 10%
- failure after Bankart repair.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Shoulder Dislocation
- Being tested
- button plates fixation system, Non-absorbable Suture Anchor
- Keywords
- button, non-absorbable suture anchor
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
button plates fixation systemDevice
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 AnchorDevice
A conventional device used in surgery for shoulder dislocation.
| Study group | Role | What they receive |
|---|---|---|
| Button Plates fixation system | Experimental | Patients receiving surgery fixed with Button Plates fixation system Receives: Device: button plates fixation system |
| Non-absorbable Suture Anchor | Active comparator | Patients receiving surgery fixed with Non-absorbable suture anchor Receives: Device: Non-absorbable Suture Anchor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rowe score
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Measured: before surgery
Rowe score
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Measured: 3 months after surgery
Rowe score
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Measured: 6 months after surgery
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Sep 2017
- Primary completion30 Sep 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan People's Hospital, The First Hospital of Jilin University
- Responsible party
- Sponsor
- Investigators
- Guoqing Cui, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960137
- Sponsor's protocol ID
- D2016052
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-randomized Controlled Study of Shoulder Dislocations Treated With Button Plates and Non-absorbable Suture Anchor
- ClinicalTrials.gov ID
- NCT04960137
- Acronym / sponsor ID
- D2016052
- Conditions
- Shoulder Dislocation
- Keywords
- button, non-absorbable suture anchor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Hunan People's Hospital, The First Hospital of Jilin University
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Button Plates fixation system | Experimental | Device: button plates fixation systemPatients receiving surgery fixed with Button Plates fixation system |
| Non-absorbable Suture Anchor | Active comparator | Device: Non-absorbable Suture AnchorPatients receiving surgery fixed with Non-absorbable suture anchor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- a glenoid defect ≥10%
- contact sport athletes with a glenoid defect < 10%
- failure after Bankart repair.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| button plates fixation systemThe 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. | Device | Button Plates fixation system |
| Non-absorbable Suture AnchorA conventional device used in surgery for shoulder dislocation. | Device | Non-absorbable Suture Anchor |
Primary outcome
Rowe score
Time frame: before surgery
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Rowe score
Time frame: 3 months after surgery
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
Rowe score
Time frame: 6 months after surgery
The Rowe score is an internationally recognized scoring system for the assessment of shoulder function.
3 secondary outcomes
ASES score
Time frame: before surgery
ASES score
Time frame: 3 months after surgery
ASES score
Time frame: 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoqing Cui study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing button plates fixation system and Non-absorbable Suture Anchor in people with Shoulder Dislocation, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rowe score (time frame: before surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021; AzTrials last refreshed its copy on 1 Nov 2026.