Clinical trial NCT04949217: An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation
Official title: An Exploratory Randomized Controlled Study of Arthroscopic Inlay Bristow Procedure for Recurrent Anterior Shoulder Dislocation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dislocation
Keywords: bristow
shoulder dislocation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone union rate
timeFrame: 3-month postoperatily
measure: Bone union rate
timeFrame: 2-year postoperatively
measure: ASES score
timeFrame: 2-year postoperatively
Secondary outcomes:
measure: dislocation rate
timeFrame: 2-year postoperatively
measure: VAS for pain score
timeFrame: 2-year postoperatively
measure: Active shoulder ranges of motion
timeFrame: 2-year postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Guoqing Cui
role: STUDY_CHAIR
References: