An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation

Study Overview
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Brief Summary
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To evaluate the clinical and radiographic outcomes of arthroscopic inlay bristow procedure in treating recurrent anterior shoulder instability.

Detailed Description
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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.

Official Title
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An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation

Conditions
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Shoulder Dislocation

Intervention / Treatment
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* Procedure: Inlay Bristow
* Procedure: Bristow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Multi-directional shoulder instability Uncontrolled epilepsy History of receiving Bristow-Latarjet procedure.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inlay Bristow Group<br>Inlay Bristow procedure | Procedure: Inlay Bristow<br>* A modified Bristow procedure<br>* Other names: Cuistow;|
| Active Comparator: Onlay Bristow Group<br>Onlay Bristow procedure | Procedure: Bristow<br>* Traditional Bristow procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 2-year postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dislocation rate | The dislocation rate was obtained by dividing the number of people who dislocated postopratively by the total number of people | 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. | 2-year postoperatively | 
| Active shoulder ranges of motion | internal rotation at the side, and external and internal rotation at 90° of abduction | 2-year postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bristow, shoulder dislocation