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

Peking University

Status: Completed

Conditions: Shoulder Dislocation

Treatments: Procedure: Bristow; Procedure: Inlay Bristow

Study type: Interventional

Funder types: Other

Identifiers

NCT04949217

M2021039

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Inlay Bristow Group

Experimental group

Description:

Inlay Bristow procedure

Treatment:

Procedure: Inlay Bristow

Onlay Bristow Group

Active Comparator group

Description:

Onlay Bristow procedure

Treatment:

Procedure: Bristow