NCT05564494 Surgical Treatment of Recurrent Shoulder Dislocations
| NCT ID | NCT05564494 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nova Scotia Health Authority |
| Condition | Shoulder Instability |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-04-25 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-04-25 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Ivan H Wong, MD
PRINCIPAL INVESTIGATOR
Nova Scotia Health Authority
Frequently Asked Questions
Who can join the NCT05564494 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 40 Years, studying Shoulder Instability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05564494 currently recruiting?
Yes, NCT05564494 is actively recruiting participants. Contact the research team at research@drivanwong.com for enrollment information.
Where is the NCT05564494 trial being conducted?
This trial is being conducted at New York, United States, Halifax, Canada.
Who is sponsoring the NCT05564494 clinical trial?
NCT05564494 is sponsored by Nova Scotia Health Authority. The principal investigator is Ivan H Wong, MD at Nova Scotia Health Authority. The trial plans to enroll 200 participants.