UnknownPhase 2

Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability

Canada150 participantsStarted 2011-03

Plain-language summary

The purpose of this prospective, randomized, controlled trial is to compare subjective patient-reported outcomes and objective clinical results between arthroscopic Bankart repair with and without arthroscopic infraspinatus remplissage in patients with anterior shoulder instability with a Hill-Sachs Defect.

Who can participate

Age range

14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 14 years or older * must have anterior shoulder instability and Hill-Sachs defect * must have anterior instability with any engaging Hill Sachs Lesion on CT scan, MRI or ultrasound and no more than 15% glenoid bone loss Exclusion Criteria: * Glenoid defect \>15% of AP diameter of glenoid * significant shoulder comorbidities (i.e, OA, previous surgery other than previous instability) * active joint or systemic infection * significant muscle paralysis * rotator cuff or Charcot's arthropathy * significant medical comorbidity that may alter effectiveness of surgical intervention * major medical illness * unable to speak French or English * psychiatric illness that precludes informed consent * unwilling to be followed for 2 years

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Western Ontario Shoulder Instability (WOSI) score

Timeframe: 24 months post-surgery

Trial details

NCT IDNCT01324531

SponsorPanam Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06

View on ClinicalTrials.gov More Other Instability, Shoulder trials