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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorMcMaster University

About this trial

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.

Eligibility criteria

Qualifiers

Males and females between the ages of 12 and 18, inclusive

Patients with a first-time traumatic anterior glenohumeral dislocation within the past 5 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)34 relating to instability

Disqualifiers

Previous dislocation episodes or instability of the affected shoulder

Previous surgeries involving the affected shoulder

History or clinical exam findings of generalized ligamentous laxity (defined as a Beighton score of 4 or more points)35

History of multi-directional instability of either shoulder

Trial design

Treatments tested in this trial

  • Arthroscopic stabilization
  • Rehabilitation including a period of immobilization followed by physical therapy

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators