Approach to Shoulder Instability (NCT02060227) | Clinical Trial Compass
CompletedNot Applicable
Approach to Shoulder Instability
Canada78 participantsStarted 2014-03-05
Plain-language summary
The primary research question is to determine whether patients who undergo a stabilization of the shoulder using a novel decision-making algorithm (ISIS Score) have improved disease-specific quality of life at 1 year post-operatively, as measured by the Western Ontario Instability Index (WOSI) compared with patients who undergo stabilization using a conventional decision-making algorithm. Secondary outcomes include the American Shoulder and Elbow Surgeon's (ASES) score, and difference in recurrence rates of dislocation between the two decision-making algorithms.
Who can participate
Age range
18 Years – 40 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
. Recurrent anterior instability (dislocation or subluxation) with or without hyperlaxity, including a clinical history of traumatic anterior instability of the shoulder, with positive apprehension or relocation tests.
. Provide consent
Exclusion criteria
. Patients with a concomitant rotator cuff lesion or humeral avulsion of the anteroinferior glenohumeral ligament (HAGL)
. An acute first-time dislocation
. Previous shoulder surgery
. Surgery for a painful, unstable shoulder without true dislocation or subluxation
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
1
Change in Western Ontario Shoulder Instability Index (WOSI)
Timeframe: From baseline to up until 24-Months Post-Operative
. Patients with active worker's compensation claims (due to the expectation of lower rates of success in this patient population)
. Active joint or systemic infection
. Patients with convulsive disorders, collagen diseases, previous shoulder surgeries, and any other conditions that might affect the mobility of the joint
. Major medical illness (life expectancy less than 2 years or unacceptably high operative risk)