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 range18 Years – 40 Years

SexALL

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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
✕. 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)

What they're measuring

Change in Western Ontario Shoulder Instability Index (WOSI)

Timeframe: From baseline to up until 24-Months Post-Operative

Trial details

NCT IDNCT02060227

SponsorOttawa Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

View on ClinicalTrials.gov More Anterior Shoulder Instability trials