Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07459777

Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode.

Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode: A Pilot Prospective CohorT Study (PROMPT-Cohort)

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
McMaster University · Academic / Other
Sex
All
Age
12 Years – 18 Years
Healthy volunteers
Not accepted

Summary

Each year within Canada and the US, more than 30,000 children and adolescents will have an injury to their shoulder resulting in a shoulder dislocation. Although the current practice is to manage this initial dislocation without surgery, the vast majority of these children and adolescents will, unfortunately continue to have instability episodes of their shoulder. Recurrent instability can cause damage to the bones and cartilage that form the shoulder resulting in potentially more difficult surgical stabilization, and possibly long-term sequela. To that effect, there is increasing interest to consider early surgical stabilization in this population. This pilot randomized controlled trial (RCT) will evaluate the feasibility of conducting a larger RCT assessing the effect of early arthroscopic stabilization compared to rehabilitation on the rate of repeat shoulder dislocations (recurrent instability), pain, and shoulder function among adolescents (aged 12-18 years) with first-time shoulder dislocations. These patients will be followed for one year.

Conditions

Interventions

TypeNameDescription
PROCEDUREArthroscopic stabilizationEarly arthroscopic stabilization with Bankart repair
OTHERRehabilitation including a period of immobilization followed by physical therapyRehabilitation including a period of immobilization followed by physical therapy

Timeline

Start date
2026-04-01
Primary completion
2028-04-01
Completion
2028-08-01
First posted
2026-03-10
Last updated
2026-03-11

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT07459777. Inclusion in this directory is not an endorsement.