Shoulder; Dislocation, ChronicNCT04460118
Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation
An observational study of Shoulder; Dislocation, Chronic, run by Peking University Third Hospital at 1 site in China.
Trial summary
Retrospective comparative case-cohort study to investigate the efficacy of the modified arthroscopic Bristow-Latarjet surgery and to compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder; Dislocation, Chronic
- What is being tested?
- Bristow surgery fixed by the screw and Bristow surgery fixed by the suture button
- Type of treatment
- Surgery or procedure
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 1 Apr 2020
- Phase
- Observational
- 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
Study population: all patients undergoing the "Inlay" Bristow surgery in our hospital between June 2015 and February 2018.
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
Retrospective comparative case-cohort study to investigate the efficacy of the modified arthroscopic Bristow-Latarjet surgery and to compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.
Read the detailed description
Background：Some studies have advocated the use of suture-button fixation during Bristow-latarjet surgery to reduce complications associated with screw fixation. However, these studies are not comparative studies, and their data are relatively incomplete.
Purpose: To compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.
Study Design: Retrospective comparative case-cohort study Methods: Patients who underwent the modified arthroscopic Bristow-Latarjet surgery between June 2015 and February 2018 were selected. Shoulders were separated into two groups based on surgical fixation method. Radiological results on 3D CT scan and clinical results were assessed preoperatively, immediately after operation, and postoperatively at 3 months, 6 months, 1 year and during the final follow-up.
- Conditions
- Shoulder; Dislocation, Chronic
- Being tested
- Bristow surgery fixed by the screw, Bristow surgery fixed by the suture button
- Medical subject headings
- Joint Dislocations, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bristow surgery fixed by the screwProcedure or surgery
Bristow surgery fixed by the screw
Bristow surgery fixed by the suture buttonProcedure or surgery
Bristow surgery fixed by the suture button
| Study group | Role | What they receive |
|---|---|---|
| screw group | coracoid bone block fixed by the screw Receives: Procedure: Bristow surgery fixed by the screw | |
| button group | coracoid bone block fixed by the suture-button Receives: Procedure: Bristow surgery fixed by the suture button |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS for pain score
The visual analog scale (VAS) for pain score is the most commonly used to describe pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.
Measured: 2 years 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: 2 years after surgery
Secondary outcomes (3)
Active shoulder ranges of motion
internal rotation at the side, and external and internal rotation at 90° of abduction,
Measured: 2 years after surgery
Bone block position
Bone block position was evaluated using postoperative CT scans.The ideal position of the bone block was defined as flush to the anterior glenoid rim in the axial view and 4 o'clock in the En face view. The bone block was considered too lateral if it went beyond the glenoid rim by more than 5 mm and it was judged to be too medial if it was medial to the rim by more than 5 mm.
Measured: immediately after surgery.
Bone union
Graft union with the glenoid was assessed using postoperative CT scans. ''Bony union'' of the transplant was defined as no radiolucent zone; ''fibrous union,'' when the transplant had a radiolucent zone of less than 5 mm; and ''migration,'' when the zone was 5 mm or more.
Measured: 3 months after surgery, 6 months after surgery, 1 year after surgery and 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Sep 2018
- Primary completion1 Sep 2019
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder; Dislocation, ChronicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoqing Cui, professor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460118
- Sponsor's protocol ID
- cui1
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- 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 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation
- ClinicalTrials.gov ID
- NCT04460118
- Acronym / sponsor ID
- cui1
- Conditions
- Shoulder; Dislocation, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 7 Jul 2020 (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.
Retrospective comparative case-cohort study to investigate the efficacy of the modified arthroscopic Bristow-Latarjet surgery and to compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.
Detailed description
Background：Some studies have advocated the use of suture-button fixation during Bristow-latarjet surgery to reduce complications associated with screw fixation. However, these studies are not comparative studies, and their data are relatively incomplete.
Purpose: To compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.
Study Design: Retrospective comparative case-cohort study Methods: Patients who underwent the modified arthroscopic Bristow-Latarjet surgery between June 2015 and February 2018 were selected. Shoulders were separated into two groups based on surgical fixation method. Radiological results on 3D CT scan and clinical results were assessed preoperatively, immediately after operation, and postoperatively at 3 months, 6 months, 1 year and during the final follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| screw group | – | Procedure: Bristow surgery fixed by the screwcoracoid bone block fixed by the screw |
| button group | – | Procedure: Bristow surgery fixed by the suture buttoncoracoid bone block fixed by the suture-button |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients undergoing the "Inlay" Bristow surgery in our hospital between June 2015 and February 2018.
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 |
|---|---|---|
| Bristow surgery fixed by the screwBristow surgery fixed by the screw | Procedure or surgery | screw group |
| Bristow surgery fixed by the suture buttonBristow surgery fixed by the suture button | Procedure or surgery | button group |
Primary outcome
VAS for pain score
Time frame: 2 years after surgery
The visual analog scale (VAS) for pain score is the most commonly used to describe pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.
ASES score
Time frame: 2 years 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 secondary outcomes
Active shoulder ranges of motion
Time frame: 2 years after surgery
Bone block position
Time frame: immediately after surgery.
Bone union
Time frame: 3 months after surgery, 6 months after surgery, 1 year after surgery and 2 years 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 7 Jul 2020.
- 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, professor principal investigator
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?
An observational study of Shoulder; Dislocation, Chronic, 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 7 Jul 2020. 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?
VAS for pain score (time frame: 2 years after surgery). The study lists 2 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 7 Jul 2020.