The Arthroscopic Treatment of Recurrent Anterior Shoulder Instability (NCT02510625)
The Arthroscopic Treatment of Recurrent Anterior Shoulder Instability: a Randomized Controlled Trial
🩺 Plain-English Summary (8th-Grade Level)
The objective of this study is to investigate arthroscopic treatments of recurrent anterior shoulder instability. Functional outcomes of arthroscopic anatomic glenoid reconstruction with bone graft will be compared to the gold standard, arthroscopic Bankart repair. The investigators hypothesize that arthroscopic anatomic glenoid reconstruction with bone graft will provide better functional outcomes and decreased risk of recurrent dislocation/subluxation. This will be a single center, double blinded, randomized controlled trial performed in Halifax, Nova Scotia, Canada. The primary outcome measured will be the Western Ontario Shoulder Instability (WOSI) score. Secondary outcomes will be subluxation, re-dislocation, and range of motion. A minimum of 200 patients will be enrolled in the study as determined by sample size calculation. Routine radiographs as well as a pre-operative CT with 3D reconstruction and MRI are obtained for all patients. The patients will then undergo a clinical examination and complete a variety of functional and quality of life surveys. Randomization will be based on surgeon skill. Two groups (Bankart repair and anatomic glenoid reconstruction) will be selected with 100 subjects each. Postoperatively, patients in both groups will follow a standardized rehabilitation protocol. The patient will follow-up with the attending surgeon at 2 weeks post-operatively for a wound check. At the 3, 6, 12, and 24 month visits the patient will again undergo the structured clinical examination conducted by a physiotherapist who is blinded to the patients' treatment group. The patient will also complete the questionnaires at each of these follow-up appointments. Complications, and subluxation/dislocation events will be documented at each follow-up evaluation. On the basis of a clinical examination and patient history, the surgeon will diagnose recurrent instability and categorize it as a traumatic or atraumatic subluxation or dislocation.
Who can join: Review the eligibility criteria below.
Location: Nova Scotia Health Authority — Halifax, Nova Scotia
Age range: 15 Years to 60 Years
🧪 Interventions in This Study
- Anatomic Glenoid Reconstruction (PROCEDURE)
- Arthroscopic bankart Repair (PROCEDURE)
📋 "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)
- Nova Scotia Health Authority — Halifax, Nova Scotia
💰 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.
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- Conservative Versus Operative - First Time Shoulder Dislocations — New York, New York
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.