Recruiting

AAGR & Bankart RepairSurgical Treatment of Recurrent Shoulder Dislocations

Sponsor:

Nova Scotia Health Authority

Code:

NCT05564494

Conditions

Shoulder Instability

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Accepted

Interventions

Bankart Repair

Anatomic Glenoid Reconstruction

Study Details

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

Study ID

NCT05564494

Start date

Apr 25, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Bankart Repair

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.

experimental: Anatomic Glenoid Reconstruction

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.

Interventions

Bankart Repair

Patients Randomized to Bankart Repair Group

Anatomic Glenoid Reconstruction

Patients Randomized to Anatomic Glenoid Reconstruction Group

Primary outcome measure

Subject Recruitment [ Time Frame: Measured throughout the entire study, up to 2 years ]
Participant Adherence [ Time Frame: Measured throughout the entire study, up to 2 years ]
Patient Follow-up [ Time Frame: Measured throughout the entire study, up to 2 years ]

Central Contacts and Locations

Central contacts

Matt Miller, PhD

9024737626 research@drivanwong.com

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Jade Refuerzo

646-929-7800 Jade.Refuerzo@nyulangone.org

Principal Investigator:

Daniel Kaplan, MD

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3H 2E1

Contacts

Sara Sparavalo, MASc

9024737626 research@drivanwong.com

Principal Investigator:

Ivan H Wong, MD

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

Arthroscopy
Shoulder Instability
Multiple Dislocations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2026-05-04.