Actively Recruiting

Phase Not Applicable
Age: 16Years - 40Years
All Genders
Healthy Volunteers
NCT05564494

Surgical Treatment of Recurrent Shoulder Dislocations

Led by Nova Scotia Health Authority · Updated on 2026-05-04

200

Participants Needed

2

Research Sites

296 weeks

Total Duration

On this page

Sponsors

N

Nova Scotia Health Authority

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Surgical Treatment of Recurrent Shoulder Dislocations

Who Can Participate

Age: 16Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Recurrent anterior glenohumeral dislocation (two or more incidents)
  • Presence of glenoid and/or humerus bone loss on imaging (x Ray, CT or MRI)
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

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Trial Site Locations

Total: 2 locations

1

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

2

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada, B3H 2E1

Actively Recruiting

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Research Team

M

Matt Miller, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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