Surgical Treatment of Recurrent Shoulder Dislocations

NCT05564494 | Recruiting DMC

• 1 other identifier: 50028
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Arthroscopy; Shoulder Instability; Multiple Dislocations

Outcome Measures

Primary Outcomes (3)

• Subject Recruitment

  Recruitment of 100 participants

  Measured throughout the entire study, up to 2 years

• Participant Adherence

  Protocol adherence

  Measured throughout the entire study, up to 2 years

• Patient Follow-up

  Proportion of Patients Followed at 24 months

  Measured throughout the entire study, up to 2 years

Secondary Outcomes (9)

• The Western Ontario Shoulder Instability Index (WOSI)

  Measured at 6 month, 1 year, and 2 year time points

• American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form

  Measured at 6 month, 1 year, and 2 year time points

• Disabilities of the Arm, Shoulder, and Hand (DASH)

  Measured at 6 month, 1 year, and 2 year time points

• MARX Physical Activity Questionnaire

  Measured at 6 month, 1 year, and 2 year time points

• Quality of Life Assessment (EQ-5D-5L)

  Measured at 6 month, 1 year, and 2 year time points

Study Arms (2)

Bankart Repair

ACTIVE COMPARATOR

Arthroscopic Bankart repair procedures will be performed according to each individual surgeon's usual technique. Procedures will be performed with the patient in the lateral or beach-chair position. Repairs for associated or conjoined superior labral anterior-to-posterior (SLAP) tears will be documented and performed at the surgeon's discretion. Labral detachments will be repaired with the use of suture-anchor fixation and arthroscopic tying techniques. Either two or three suture anchors will be used. Capsular redundancy will be addressed with arthroscopic suture plication at the surgeon's discretion. Surgeons will mobilize the capsulolabral tissue as deemed necessary. Surgical time and video of the operation will be recorded, and photographs will be taken documenting any bone loss.

Procedure: Bankart Repair

Anatomic Glenoid Reconstruction

EXPERIMENTAL

The surgical technique was the lateral decubitus all-arthroscopic anatomic glenoid reconstruction procedure for treatment of anterior shoulder instability as described by Wong et al. (2015). The procedure is done in a semi-lateral decubitus position that assists with optimal graft placement on the native glenoid. The investigators utilize the cannulated Bristow-Latarjet Instability Shoulder System (Depuy-Mitek, MA, USA). The surgical technique is identical to that of arthroscopic Bankart repair with one additional step. Prior to insertion of anchors, one additional medal portal is created for insertion of the bone graft. The distal tibia allograft is prepared; the cannulated guide is attached and advanced through the rotator interval and secured with two cannulated screws. Finally, the Bankart repair is performed above the graft. Surgical time and video of the operation will be recorded, and photographs will be taken documenting any bone loss.

Procedure: Anatomic Glenoid Reconstruction

Interventions

Bankart Repair PROCEDURE

Patients Randomized to Bankart Repair Group

Also known as: Arthroscopic bankart repair

Bankart Repair

Anatomic Glenoid Reconstruction PROCEDURE

Patients Randomized to Anatomic Glenoid Reconstruction Group

Also known as: Arthroscopic distal tibia bone graft

Anatomic Glenoid Reconstruction

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Recurrent anterior glenohumeral dislocation (two or more incidents)
• Presence of glenoid and/or humerus bone loss on imaging (x Ray, CT or MRI)

You may not qualify if:

• Uncontrolled diabetes (Hgb A1C \>7%)
• Prior surgery of affected shoulder
• Pregnancy
• Multidirectional instability
• Posterior instability
• Paralysis of the shoulder
• Cancer
• Severe systemic illness
• Presence of massive rotator cuff tear
• Patients that present with \< 10% or \> 25% bone loss under preoperative imaging.
• Generalized laxity (\>5/9 Beighton Score)

Sponsors & Collaborators

• The Hawkins Foundation: collaborator
• Nova Scotia Health Authority: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• NYU Langone Health: collaborator
• Panam Clinic: collaborator
• Vancouver Coastal Health: collaborator
• University of British Columbia: collaborator
• Ottawa Hospital Research Institute: collaborator
• Children's Hospital of Eastern Ontario Research Institute: collaborator
• Horizon Health Network: collaborator
• Research St. Joseph's - Hamilton: collaborator
• London Health Sciences Centre Research Institute: collaborator
• University of Utah: collaborator
• Orlando Health, Inc.: collaborator
• TSAOG Orthopaedics and Spine: collaborator

Study Sites (2)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2E1, Canada

RECRUITING

Study Officials

• Ivan H Wong, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matt Miller, PhD

CONTACT

9024737626; research@drivanwong.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a pilot multi-center, double-blinded, RCT of a minimum of 100 patients, performed in five cities at seven sites (Calgary (2 sites), Winnipeg (2 sites), Montreal, Halifax, and Ottawa).

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: October 3, 2022
• Study Start: April 25, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)