Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trau… (NCT04887337) | Clinical Trial Compass
TerminatedNot Applicable
Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode
Stopped: Poor recruitment
Canada2 participantsStarted 2022-09-19
Plain-language 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.
Who can participate
Age range12 Years – 18 Years
SexALL
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Inclusion criteria
✓. Males and females between the ages of 12 and 18, inclusive
✓. Patients with a first-time traumatic anterior glenohumeral dislocation within the past 3 months
✓. Anterior glenohumeral dislocation confirmed by radiography, reduction required by medical personnel, or demonstration of anterior apprehension on physical examination following injury to the shoulder
✓. MRI or MRA demonstrating disruption of the glenohumeral soft tissues (including the labrum, periosteum, or inferior glenohumeral ligament) relating to instability
✓. Patients who have the ability to speak, understand, and read English
✓. Provision of informed consent (age 18) or parental consent (ages 12-17, inclusive)
✓. Provision of informed child assent (ages 12-17, inclusive)
Exclusion criteria
✕. Previous dislocation episodes or instability of the affected shoulder