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NCT05715021
Randomized Trial Evaluating First Time Shoulder Dislocation
Conditions: Shoulder Dislocation, Sport Injury, Anterior Dislocation
Sex: All
Ages: 14 Years – 50 Years
Phase: NA
Enrollment: 100
Sponsor: McMaster University
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-surgical intervention on the risk of recurrent anterior dislocation rates and functional outcomes following in patients presenting with a first-time dislocation (FSD) over a 24-month period.
Eligibility Criteria
Inclusion Criteria:Men and women ages 14-50 years;Diagnosis of first-time shoulder anterior dislocation 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 Criteria:Patients that cannot undergo a surgery.Patients with concomitant injuries (full thickness cuff tear);Previous shoulder surgery;Patients that will likely have problems, in the judgment of the investigators, with maintaining follow-up;Epilepsy/seizure disorder:Patients who are or at risk of being incarcerated;Diagnosis of multidirectional instability;Dislocation without trauma, in a context of hyper laxity or atraumatic instability;Bone glenoid defect confirmed by radiographs;Delay greater than 90 days between luxation and surgical treatment;Against indication to anesthesia;Pregnant or nursing women;Cases involving litigation or workplace insurance claims (e.g.
WSIB);
Source: ClinicalTrials.gov (NCT05715021). StuddyBuddy aggregates publicly available trial information.