RCT Evaluating First Time Shoulder Dislocation
Randomized Trial Evaluating First Time Shoulder Dislocation: Surgery vs Conservative Care
McMaster University
100 participants
Jul 12, 2023
INTERVENTIONAL
Conditions
Summary
The primary objective of the pilot study is to assess the feasibility of a definitive trial to determine the effect of arthroscopic soft tissue stabilization vs. non-operative management on the risk of recurrent anterior dislocation rates and functional outcomes following in patients presenting with a first-time dislocation (FTD) over a 24-month period.
Eligibility
Inclusion Criteria3
- Patients ages 14-40 years;
- Diagnosis of first-time shoulder anterior dislocation having occurred within the past 3 months confirmed either by radiographic evidence or documented reduction of anterior shoulder dislocation as well as physical examination eliciting unwanted glenohumeral translation with reproduction of symptoms;
- Provision of informed consent.
Exclusion Criteria10
- Patients that cannot undergo surgery or anesthesia;
- Patients with concomitant injuries (rotator cuff tear, fracture)
- Previous shoulder surgery;
- Patients that will likely have problems with maintaining follow-up or are incarcerated;
- Epilepsy/seizure disorder;
- Pregnancy;
- Diagnosis of multidirectional instability;
- Bony glenoid defect (bony Bankart) >10% as measured on preop imaging;
- Dislocation without trauma, in a context of hyper laxity or atraumatic instability;
- Cases involving litigation or workplace insurance claims (e.g., WSIB).
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Interventions
Participants will undergo arthroscopic stabilization.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05715021