Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode. (NCT07459777)
Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode: A Pilot Prospective CohorT Study (PROMPT-Cohort)
🩺 Plain-English Summary (8th-Grade Level)
Each year within Canada and the US, more than 30,000 children and adolescents will have an injury to their shoulder resulting in a shoulder dislocation. Although the current practice is to manage this initial dislocation without surgery, the vast majority of these children and adolescents will, unfortunately continue to have instability episodes of their shoulder. Recurrent instability can cause damage to the bones and cartilage that form the shoulder resulting in potentially more difficult surgical stabilization, and possibly long-term sequela. To that effect, there is increasing interest to consider early surgical stabilization in this population. This pilot randomized controlled trial (RCT) will evaluate the feasibility of conducting a larger RCT assessing the effect of early arthroscopic stabilization compared to rehabilitation on the rate of repeat shoulder dislocations (recurrent instability), pain, and shoulder function among adolescents (aged 12-18 years) with first-time shoulder dislocations. These patients will be followed for one year.
Who can join: Review the eligibility criteria below.
Location: McMaster University — Hamilton, Ontario
Age range: 12 Years to 18 Years
🧪 Interventions in This Study
- Arthroscopic stabilization (PROCEDURE)
- Rehabilitation including a period of immobilization followed by physical therapy (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- McMaster University — Hamilton, Ontario
📞 Contact the Study Coordinator
Phone: (905) 521-2100
Email: simunon@mcmaster.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Shoulder Dislocation
- Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation - STABLE Definitive Trial — Hamilton, Ontario
- Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability — Winnipeg, Manitoba
- The Arthroscopic Treatment of Recurrent Anterior Shoulder Instability — Halifax, Nova Scotia
- Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation — Hamilton, Ontario
- Conservative Versus Operative - First Time Shoulder Dislocations — New York, New York
Explore by condition: All Shoulder Dislocation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.