Shoulder DislocationNCT04949217
An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation
A study testing Inlay Bristow and Bristow in people with Shoulder Dislocation, run by Peking University Third Hospital.
Trial summary
To evaluate the clinical and radiographic outcomes of arthroscopic inlay bristow procedure in treating recurrent anterior shoulder instability. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- Inlay Bristow and Bristow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 17 Jan 2017to 31 May 2021
- 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
- Recurrent anterior shoulder instability based on medical history, physical examination, and radiological results.
- A glenoid defect ≥10% but <25%
- Participation in high-demand (collision and overhead) sports combined with the presence of a glenoid defect <25% of the glenoid or without defect
- Failure after Bankart repair
Who cannot join
- Multi-directional shoulder instability
- Uncontrolled epilepsy
- History of receiving Bristow-Latarjet procedure.
About this study
To evaluate the clinical and radiographic outcomes of arthroscopic inlay bristow procedure in treating recurrent anterior shoulder instability.
Read the detailed description
Aim: To compare the clinical and radiographic outcomes following the arthroscopic Chinese Unique Inlay Bristow (Cuistow) procedure and the arthroscopic Bristow procedure.
Background: The Cuistow procedure is a modified Bristow surgery in which a Mortise and Tenon structure was added to the contact surface between the coracoid tip and the glenoid. In previous retrospective study, patients received Cuistow procedure have satisfying clinical performance and excellent postoperative bone healing rate (96.1%). However, no prospective randomized controlled trial was performed.
Methods: 70 patients with recurrent anterior shoulder instability were included and randomized to either an arthroscopic Cuistow procedure or arthroscopic Bristow procedure. Radiological evaluations with 3D CT scan were performed preoperatively, immediately after the operation, and postoperatively at three months and during the final follow-up (more than 2 years). Clinical assessment for a minimum of 24 months including the 10-point visual analog scale for pain and subjective instability, University of California at Los Angeles scoring system (UCLA score), American Shoulder and Elbow Surgeons score (ASES score), ROWE score, Subjective Shoulder Value (SSV) and active range of motion were completed by independent observers and analyzed.
- Conditions
- Shoulder Dislocation
- Being tested
- Inlay Bristow, Bristow
- Keywords
- bristow, shoulder dislocation
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inlay BristowProcedure or surgery
Also called Cuistow
A modified Bristow procedure
BristowProcedure or surgery
Traditional Bristow procedure
| Study group | Role | What they receive |
|---|---|---|
| Inlay Bristow Group | Experimental | Inlay Bristow procedure Receives: Procedure: Inlay Bristow |
| Onlay Bristow Group | Active comparator | Onlay Bristow procedure Receives: Procedure: Bristow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone union rate
Bone healing was observed in 3D-CT. The bone healing rate was obtained by dividing the number of people who achieved bone healing by the total number of people
Measured: 3-month postoperatily
Bone union rate
Bone healing was observed in 3DCT. The bone healing rate was obtained by dividing the number of people who achieved bone healing by the total number of people
Measured: 2-year postoperatively
ASES score
The ASES score (Michener 2002) is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function.
Measured: 2-year postoperatively
Secondary outcomes (3)
dislocation rate
The dislocation rate was obtained by dividing the number of people who dislocated postopratively by the total number of people
Measured: 2-year postoperatively
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-year postoperatively
Active shoulder ranges of motion
internal rotation at the side, and external and internal rotation at 90° of abduction
Measured: 2-year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start17 Jan 2017
- Primary completion20 Mar 2018
- Study completion31 May 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoqing Cui, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949217
- Sponsor's protocol ID
- M2021039
- Status last verified
- Jul 2021
- First submitted
- 25 Jun 2021
- Last updated
- 13 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 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation
- ClinicalTrials.gov ID
- NCT04949217
- Acronym / sponsor ID
- M2021039
- Conditions
- Shoulder Dislocation
- Keywords
- bristow, shoulder dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 2 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.
To evaluate the clinical and radiographic outcomes of arthroscopic inlay bristow procedure in treating recurrent anterior shoulder instability.
Detailed description
Aim: To compare the clinical and radiographic outcomes following the arthroscopic Chinese Unique Inlay Bristow (Cuistow) procedure and the arthroscopic Bristow procedure.
Background: The Cuistow procedure is a modified Bristow surgery in which a Mortise and Tenon structure was added to the contact surface between the coracoid tip and the glenoid. In previous retrospective study, patients received Cuistow procedure have satisfying clinical performance and excellent postoperative bone healing rate (96.1%). However, no prospective randomized controlled trial was performed.
Methods: 70 patients with recurrent anterior shoulder instability were included and randomized to either an arthroscopic Cuistow procedure or arthroscopic Bristow procedure. Radiological evaluations with 3D CT scan were performed preoperatively, immediately after the operation, and postoperatively at three months and during the final follow-up (more than 2 years). Clinical assessment for a minimum of 24 months including the 10-point visual analog scale for pain and subjective instability, University of California at Los Angeles scoring system (UCLA score), American Shoulder and Elbow Surgeons score (ASES score), ROWE score, Subjective Shoulder Value (SSV) and active range of motion were completed by independent observers and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inlay Bristow Group | Experimental | Procedure: Inlay BristowInlay Bristow procedure |
| Onlay Bristow Group | Active comparator | Procedure: BristowOnlay Bristow procedure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Recurrent anterior shoulder instability based on medical history, physical examination, and radiological results.
- A glenoid defect ≥10% but <25%
- Participation in high-demand (collision and overhead) sports combined with the presence of a glenoid defect <25% of the glenoid or without defect
- Failure after Bankart repair
Key exclusion criteria (3 listed)
- Multi-directional shoulder instability
- Uncontrolled epilepsy
- History of receiving Bristow-Latarjet procedure.
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 |
|---|---|---|
| Inlay BristowAlso: CuistowA modified Bristow procedure | Procedure or surgery | Inlay Bristow Group |
| BristowTraditional Bristow procedure | Procedure or surgery | Onlay Bristow Group |
Primary outcome
Bone union rate
Time frame: 3-month postoperatily
Bone healing was observed in 3D-CT. The bone healing rate was obtained by dividing the number of people who achieved bone healing by the total number of people
Bone union rate
Time frame: 2-year postoperatively
Bone healing was observed in 3DCT. The bone healing rate was obtained by dividing the number of people who achieved bone healing by the total number of people
ASES score
Time frame: 2-year postoperatively
The ASES score (Michener 2002) is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function.
3 secondary outcomes
dislocation rate
Time frame: 2-year postoperatively
VAS for pain score
Time frame: 2-year postoperatively
Active shoulder ranges of motion
Time frame: 2-year postoperatively
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 13 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Shoulder Dislocation
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
RecruitingObservational study
Prospective Descriptive Study of Injuries Associated to Anterior Shoulder Dislocations in Patients Over 40 Years
Anterior Glenohumeral Dislocations
Not yet recruiting
Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode.
Shoulder Dislocation
Recruiting
Validation of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation
Return to Sport, Shoulder Dislocation or Subluxation
RecruitingObservational study
Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Proximal Humeral Fracture, Fracture Dislocation
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
Questions about this trial
What is this clinical trial studying?
A study testing Inlay Bristow and Bristow in people with Shoulder Dislocation, run by Peking University Third Hospital.
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 4 inclusion and 3 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 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Bone union rate (time frame: 3-month postoperatily). 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 13 Jul 2021.