RecruitingNot Applicable

RCT Evaluating First Time Shoulder Dislocation

Canada100 participantsStarted 2023-07-12

Plain-language 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.

Who can participate

Age range14 Years – 40 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

Recruitment Feasibility

Timeframe: 10 months

Follow-up

Timeframe: 2 years

Surgery within 3 months of enrollment

Timeframe: 3 months

Crossovers

Timeframe: 2 years

Trial details

NCT IDNCT05715021

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-01

Contact for this trial

Danielle Dagher, MSc

905-522-1155 ddagher@stjoes.ca

View on ClinicalTrials.gov More Shoulder Dislocation trials