Status:
COMPLETED
Arthroscopic Versus Open Stabilization for Traumatic Shoulder Instability
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Calgary Regional Health Authority (CRHA)
Calgary Orthopaedic Research and Education Fund
Conditions:
Joint Instability
Shoulder Dislocation
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare arthroscopic and open shoulder stabilization procedures by measuring the disease-specific quality of life outcome in patients with traumatic unidirectional ante...
Detailed Description
Shoulder instability most commonly affects people in the late teens to mid thirties, which are the most active years, recreational and vocational. The resulting disability, time lost from work, as wel...
Eligibility Criteria
Inclusion
- Clinical:
- Age 14 years or greater
- Diagnosis of traumatic anterior shoulder instability, made by meeting all of the following:
- Radiographic evidence or documented physician assisted reduction of anterior shoulder dislocation following a traumatic injury.
- Ability to elicit unwanted glenohumeral translation which reproduce symptoms with one of the following tests: anterior apprehension, relocation test, or anterior load and shift test
- Radiological:
- Closed growth plate on a standardized series of x-rays consisting of a minimum of an anteroposterior view, lateral in the scapular plane and an axillary view.
Exclusion
- Clinical:
- Diagnosis of multidirectional instability (MDI) or multidirectional laxity with anteroinferior instability (MDL-AII), made by two or more of:
- Symptomatic (pain or discomfort) in inferior or posterior direction
- Ability to elicit unwanted posterior glenohumeral translation that reproduces symptoms with posterior apprehension tests, or posterior load and shift test
- Positive sulcus sign of 1cm or greater that reproduces patient's clinical symptoms
- Previous surgery on the affected shoulder other than diagnostic arthroscopy
- Cases involving litigation
- Significant tenderness of acromioclavicular/sternoclavicular joints on affected side
- Confirmed connective tissue disorder (ie: Ehlers-Danlos, Marfan)
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00251264
Start Date
November 1 2001
End Date
December 1 2013
Last Update
July 13 2015
Active Locations (1)
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1
University of Calgary Sport Medicine Centre
Calgary, Alberta, Canada, T2N 1N4