Surgical Treatment of Recurrent Shoulder Dislocations

Summary

This is a pilot multi-centre, double blinded randomized controlled trial. The primary outcome of this pilot trial will be feasibility. Prior to conducting a large definitive trial, the investigators will conduct this pilot trial comparing arthroscopic Bankart repair with arthroscopic anatomic glenoid reconstruction (AAGR), evaluating recurrent dislocation rates and functional outcomes over a 24-month period. The feasibility objectives are: (1) to evaluate the investigators ability to recruit patients across multiple sites and (2) to assess study protocol adherence and ability to follow patients to 24 months. Clinical objectives for the pilot trial are exploratory only. The investigators wish to gather means and standard deviations for clinical outcomes to power their future definitive trial. The objectives of the definitive trial will include a comparison of patient-reported outcomes at the two-year post-operative time point, differences in recurrence rates, complication rates, functional shoulder assessments, and return to work/sport.

Conditions

• Shoulder Instability

Interventions

PROCEDURE

Bankart Repair

Patients Randomized to Bankart Repair Group

PROCEDURE

Anatomic Glenoid Reconstruction

Patients Randomized to Anatomic Glenoid Reconstruction Group

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• NYU Langone Health

  collaborator OTHER

• Panam Clinic

  collaborator OTHER

• Vancouver Coastal Health

  collaborator OTHER_GOV

• University of British Columbia

  collaborator OTHER

• Ottawa Hospital Research Institute

  collaborator OTHER

• Children's Hospital of Eastern Ontario Research Institute

  collaborator OTHER

• Horizon Health Network

  collaborator OTHER

• Research St. Joseph's - Hamilton

  collaborator UNKNOWN

• London Health Sciences Centre Research Institute

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Orlando Health, Inc.

  collaborator OTHER

• TSAOG Orthopaedics and Spine

  collaborator UNKNOWN

• The Hawkins Foundation

  collaborator OTHER

• Nova Scotia Health Authority

  lead OTHER

Principal Investigators

• Ivan H Wong, MD · Nova Scotia Health Authority

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-04-25

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• United States
• Canada

Study Locations