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NCT05705479
Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation - STABLE Definitive Trial
Conditions: Shoulder Dislocation, Sport Injuries, Anterior Dislocation
Sex: All
Ages: 18 Years – 50 Years
Phase: NA
Enrollment: 126
Sponsor: McMaster University
Location: Canada
Summary
The primary objective of the study is to evaluate the functional shoulder recovery of patients with recurrent shoulder dislocations at 24 months when treated with either arthroscopic capsuloligamentous repair (Bankart Procedure +/- Remplissage) or coracoid transfer (Latarjet procedure).
Eligibility Criteria
Inclusion Criteria:Men and women ages 18-50 years;Diagnosis of post-traumatic recurrent anterior dislocation.
This will require a minimum of 2 episodes of documented dislocations either by radiographic evidence or documented reduction of anterior shoulder dislocation as well as physical examination eliciting unwanted glenohumeral translation with reproduction of symptoms;Mild glenoid bone loss as defined on CT by standardized and reproducible best-fit circle technique (>10% but <20%);Provision of informed consent.Exclusion Criteria:Patients with concomitant injuries (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;Cases involving litigation or workplace insurance claims (e.g.
WSIB);Confirmed connective tissue disorder (Ehlers-Danlos, Marfans) or Beighton hypermobility score > 6.Pregnancy.
Source: ClinicalTrials.gov (NCT05705479). StuddyBuddy aggregates publicly available trial information.