Conservative Versus Operative - First Time Shoulder Dislocations
Part of paid clinical trials in New York, New York.
- Sponsor
- Columbia University
- Study ID
- NCT05532150
- Status
- Not Yet Recruiting
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Conditions
- Shoulder Dislocation
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Arthroscopic Bankart repair — PROCEDUREParticipants in this group will undergo minimally invasive surgery to repair their shoulder with a technique called a Bankart repair.
- Physical therapy — PROCEDUREParticipants in this group will follow a specific physical therapy rehabilitation protocol
Study Details
There is no consensus regarding whether rehabilitation or surgical stabilization leads to optimized outcomes for treatment of primary anterior shoulder dislocations. This prospective, randomized controlled trial therefore aims to compare arthroscopic Bankart repair versus physical therapy for the treatment of primary anterior shoulder dislocations.
Key Dates
- Start date
- Sep 30, 2026
- Status verified
- Sep 2025
- Primary completion
- Sep 30, 2032
- Completion
- Sep 30, 2032
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Operative groupThe operative group will undergo an arthroscopic Bankart repair, which is type of surgery used to repair a dislocated shoulder.
- Active Comparator: Non-operative groupThe non-operative group will undergo physical therapy following a specific rehabilitation schedule.
Primary Outcome Measure
Change in Western-Ontario Shoulder instability Index Score at 2 weeks [ Time Frame: Baseline and 2 weeks ]
Central Contacts
- David P Trofa, MD212 305 5974
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | David P Trofa, MD (PRINCIPAL_INVESTIGATOR) |
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