An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation
NCT ID: NCT04949217
Last Updated: 2021-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2017-01-17
2021-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Inlay Bristow Group
Inlay Bristow procedure
Inlay Bristow
A modified Bristow procedure
Onlay Bristow Group
Onlay Bristow procedure
Bristow
Traditional Bristow procedure
Interventions
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Inlay Bristow
A modified Bristow procedure
Bristow
Traditional Bristow procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Uncontrolled epilepsy
* History of receiving Bristow-Latarjet procedure.
ALL
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Principal Investigators
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Guoqing Cui
Role: STUDY_CHAIR
Peking University Third Hospital
Other Identifiers
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M2021039
Identifier Type: -
Identifier Source: org_study_id
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