Comparing early surgery to rehabilitation for first-time shoulder dislocations in adolescents

Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode (PROMPT): A Pilot Randomized Controlled Trial

This study is testing whether early surgery or rehabilitation works better for teenagers who have had their shoulder dislocated for the first time, to see which option helps them avoid future dislocations and feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 12 Years to 18 Years
• Sex: All
• Sponsor: McMaster University (Academic / other)
• Locations: 1 site (Hamilton, Ontario)
• Trial ID: NCT04887337 on ClinicalTrials.gov

What this trial studies

This pilot randomized controlled trial evaluates the feasibility of a larger study comparing early arthroscopic stabilization to rehabilitation for adolescents aged 12-18 who have experienced a first-time traumatic anterior shoulder dislocation. The study aims to assess the impact of these two approaches on the rate of repeat dislocations, pain levels, and shoulder function. Participants will be randomly assigned to either receive surgical intervention or undergo a rehabilitation program that includes immobilization followed by physical therapy. The goal is to determine if early surgical intervention can reduce the risk of recurrent instability and improve long-term outcomes.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12-18 who have experienced a first-time traumatic anterior shoulder dislocation within the past three months.

Not a fit: Patients with previous dislocation episodes or surgeries involving the affected shoulder will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for adolescents with shoulder dislocations, potentially reducing the risk of recurrent dislocations and associated complications.

How similar studies have performed: While there is increasing interest in early surgical stabilization for shoulder dislocations, this approach is still being evaluated, and the study represents a novel investigation in this specific population.

Eligibility criteria

Inclusion Criteria:

1. Males and females between the ages of 12 and 18, inclusive
2. Patients with a first-time traumatic anterior glenohumeral dislocation within the past 3 months
3. Anterior glenohumeral dislocation confirmed by radiography, reduction required by medical personnel, or demonstration of anterior apprehension on physical examination following injury to the shoulder
4. MRI or MRA demonstrating disruption of the glenohumeral soft tissues (including the labrum, periosteum, or inferior glenohumeral ligament) relating to instability
5. Patients who have the ability to speak, understand, and read English
6. Provision of informed consent (age 18) or parental consent (ages 12-17, inclusive)
7. Provision of informed child assent (ages 12-17, inclusive)

Exclusion Criteria:

1. Previous dislocation episodes or instability of the affected shoulder
2. Previous surgeries involving the affected shoulder
3. History or clinical exam findings of generalized ligamentous laxity (defined as a Beighton score of 4 or more points)
4. History of multi-directional instability of either shoulder
5. Concomitant fracture of the tuberosity, humerus, or glenoid (excluding a Bankart or Hill Sachs lesion)
6. Bony Bankart lesion exceeding 15% of the glenoid surface (using the best-fit circle method on MRI)
7. Hill Sachs lesion exceeding 15% of the humeral diameter (Measured on transaxial slice of MRI similar to Salomonsson et al.)
8. A neurological injury of the affected arm
9. Patients who will likely have problems, in the judgement of the investigator, with maintaining follow-up
10. Any other reason(s) the investigator feels is relevant for excluding the patient

Where this trial is running

Hamilton, Ontario

• McMaster University — Hamilton, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Nicole Simunovic, MSc

Conditions Shoulder Dislocation