An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation
Study Details
Study Description
Brief Summary
To evaluate the clinical and radiographic outcomes of arthroscopic inlay bristow procedure in treating recurrent anterior shoulder instability.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Inlay Bristow Group Inlay Bristow procedure |
Procedure: Inlay Bristow
A modified Bristow procedure
Other Names:
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Active Comparator: Onlay Bristow Group Onlay Bristow procedure |
Procedure: Bristow
Traditional Bristow procedure
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Outcome Measures
Primary Outcome Measures
- Bone union rate [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 [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 [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.
Secondary Outcome Measures
- dislocation rate [2-year postoperatively]
The dislocation rate was obtained by dividing the number of people who dislocated postopratively by the total number of people
- VAS for pain score [2-year postoperatively]
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.
- Active shoulder ranges of motion [2-year postoperatively]
internal rotation at the side, and external and internal rotation at 90° of abduction
Eligibility Criteria
Criteria
Inclusion Criteria:
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Recurrent anterior shoulder instability based on medical history, physical examination, and radiological results.
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A glenoid defect ≥10% but <25%
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Participation in high-demand (collision and overhead) sports combined with the presence of a glenoid defect <25% of the glenoid or without defect
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Failure after Bankart repair
Exclusion Criteria:
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Multi-directional shoulder instability
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Uncontrolled epilepsy
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History of receiving Bristow-Latarjet procedure.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking University Third Hospital
Investigators
- Study Chair: Guoqing Cui, Peking University Third Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M2021039