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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Arthroscopic stabilization

    Procedure/Surgery

    Early arthroscopic stabilization with Bankart repair

  • Rehabilitation including a period of immobilization followed by physical therapy

    Other intervention

    Rehabilitation including a period of immobilization followed by physical therapy

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arthroscopic stabilizationExperimental treatment 1 intervention
Group B: Rehabilitation including a period of immobilization followed by physical therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of recurrent shoulder dislocation

Recurrent shoulder dislocations will be defined as an episode of repeat anterior shoulder dislocation either requiring reduction by medical personnel, an x-ray confirming anterior dislocation of the shoulder, or the requirement of surgical management of recurrent instability.

Time frame
12 months
2

Visual Analogue Scale

100-point pain scale, range 0-100, higher score indicates worse pain.

Time frame
12 months

Secondary outcomes

1

Pediatric and Adolescent Shoulder and Elbow Survey

The Pediatric and Adolescent Shoulder and Elbow Survey has recently been adopted as a shoulder and elbow function scale designed specifically for children and adolescents aged 10-18, and has shown to be well received and understood in this age group. The total score - 100 maximum points - is weighted 50% for pain and 50% for function.

Time frame
12 months
2

Euro-Qol 5 Dimensions Youth

The Euro-Qol 5 Dimensions Youth comprises 5 dimensions of health (mobility, self-care \[looking after myself\], usual activities, pain/discomfort, and anxiety/depression \[feeling worried, sad or unhappy\]). Score range 0-100, higher score indicating worse outcomes.

Time frame
12 months
3

Rate of adverse events (other than recurrent shoulder dislocations)

Defined as any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study.

Time frame
12 months

Other outcomes

Sponsors and contacts

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