RCT Evaluating First Time Shoulder Dislocation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-40
SponsorMcMaster University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Bankart + Remplissage Procedure
Treatment groups
100 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov