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

Not Applicable

Completed

• Conditions: Shoulder Dislocation
• Interventions: Procedure: Bristow; Procedure: Inlay Bristow

• Registration Number: NCT04949217
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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 Timeline

• Study Start: 2017-01-17
• Primary Completion: 2018-03-20
• Study Completion: 2021-05-31
• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-06-25
• Status Verified: 2021-07
• Study First Posted: 2021-07-02
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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Exclusion Criteria

• Multi-directional shoulder instability
• Uncontrolled epilepsy
• History of receiving Bristow-Latarjet procedure.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Onlay Bristow Group	Bristow	Onlay Bristow procedure
Inlay Bristow Group	Inlay Bristow	Inlay Bristow procedure

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
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
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