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

NCT04949217 | Completed DMC

• 1 other identifier: M2021039
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Shoulder Dislocation

Keywords

bristow; shoulder dislocation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (3)

• dislocation rate

  2-year postoperatively

• VAS for pain score

  2-year postoperatively

• Active shoulder ranges of motion

  2-year postoperatively

Study Arms (2)

Inlay Bristow Group

EXPERIMENTAL

Inlay Bristow procedure

Procedure: Inlay Bristow

Onlay Bristow Group

ACTIVE COMPARATOR

Onlay Bristow procedure

Procedure: Bristow

Interventions

Inlay Bristow PROCEDURE

A modified Bristow procedure

Also known as: Cuistow

Inlay Bristow Group

Bristow PROCEDURE

Traditional Bristow procedure

Onlay Bristow Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Guoqing Cui

  Peking University Third Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 2, 2021
• Study Start: January 17, 2017
• Primary Completion: March 20, 2018
• Study Completion: May 31, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share