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

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

Study Overview

• Status: Completed
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Procedure: Inlay Bristow; Procedure: Bristow

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inlay Bristow Group; Inlay Bristow procedure	Procedure: Inlay Bristow; A modified Bristow procedure; Other Names: Cuistow
Active Comparator: Onlay Bristow Group; Onlay Bristow procedure	Procedure: Bristow; Traditional Bristow procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Guoqing Cui, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2017
• Primary Completion (Actual): March 20, 2018
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: shoulder dislocation; bristow
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: M2021039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No