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NCT Number: NCT07459777

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

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.

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Key information

Conditions

Shoulder Dislocation Joint Diseases Joint Dislocations Musculoskeletal Diseases Shoulder Injuries Wounds and Injuries

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8N3Z5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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
  • Patients who have the ability to speak, understand, and read the language of the clinical site
  • 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
  • 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
  • Concomitant fracture of the tuberosity, humerus, or glenoid (excluding a Bankart or Hill Sachs lesion)
  • Bony Bankart lesion exceeding 15% of the glenoid surface (using the best-fit circle method on MRI)36
  • Hill Sachs lesion exceeding 15% of the humeral diameter (Measured on transaxial slice of MRI similar to Salomonsson et al.)37
  • A neurological injury of the affected arm
  • Patients who will likely have problems, in the judgement of the investigator, with maintaining follow-up
  • Any other reason(s) the investigator feels is relevant for excluding the patient

Treatment and study plan

Arthroscopic stabilization

Procedure

Early arthroscopic stabilization with Bankart repair

Rehabilitation including a period of immobilization followed by physical therapy

Other

Rehabilitation including a period of immobilization followed by physical therapy

Primary outcomes

  1. Rate of recurrent shoulder dislocation

    Time frame: 12 months

    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.

  2. Visual Analogue Scale

    Time frame: 12 months

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

Secondary outcomes

  1. Pediatric and Adolescent Shoulder and Elbow Survey

    Time frame: 12 months

    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.

  2. Euro-Qol 5 Dimensions Youth

    Time frame: 12 months

    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.

  3. Rate of adverse events (other than recurrent shoulder dislocations)

    Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Simunovic, MSc

CONTACT

[email protected]

905-521-2100 ext. 73507

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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)

Acronym: PROMPTCohort

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 10, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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