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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04949217
Enrollment
70
Registered
2021-07-02
Start date
2017-01-17
Completion date
2021-05-31
Last updated
2021-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Dislocation

Keywords

bristow, shoulder dislocation

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.

Interventions

PROCEDUREInlay Bristow

A modified Bristow procedure

PROCEDUREBristow

Traditional Bristow procedure

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Bone union rate3-month postoperatilyBone 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
ASES score2-year postoperativelyThe 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

MeasureTime frameDescription
dislocation rate2-year postoperativelyThe dislocation rate was obtained by dividing the number of people who dislocated postopratively by the total number of people
VAS for pain score2-year postoperativelyThe 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 motion2-year postoperativelyinternal rotation at the side, and external and internal rotation at 90° of abduction

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026