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Procedure

Arthroscopic Stabilization vs Rehabilitation for Shoulder Dislocation (PROMPT Trial)

N/A

Recruiting

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Anterior glenohumeral dislocation confirmed by radiography, reduction required by medical personnel, or demonstration of anterior apprehension on physical examination following injury to the shoulder

Must not have

Hill Sachs lesion exceeding 15% of the humeral diameter (Measured on transaxial slice of MRI similar to Salomonsson et al.)

Previous dislocation episodes or instability of the affected shoulder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate the feasibility of conducting a larger trial assessing the effect of early arthroscopic stabilization compared to rehabilitation on the rate of repeat shoulder dislocations, pain, and shoulder function among adolescents with first-time shoulder dislocations.

Who is the study for?

Adolescents aged 12-18 with a first-time traumatic shoulder dislocation confirmed by radiography, needing reduction or showing anterior apprehension. They must have MRI evidence of soft tissue damage and be able to understand English. Consent is required from the individual or parents for minors.

What is being tested?

This trial tests early arthroscopic stabilization surgery against rehabilitation (immobilization followed by physical therapy) in adolescents after their first shoulder dislocation. It aims to see which method better prevents repeat dislocations, reduces pain, and improves shoulder function over one year.

What are the potential side effects?

Arthroscopic stabilization may lead to risks such as infection, bleeding, nerve injury, stiffness or loss of motion. Rehabilitation side effects could include discomfort during exercises and potential for re-injury if not properly managed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 18 years old.

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My shoulder was dislocated forward and needed medical help to fix.

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I dislocated my shoulder for the first time within the last 3 months.

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My MRI shows damage to shoulder tissues causing instability.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My shoulder injury is larger than 15% of my upper arm bone's width.

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My shoulder has dislocated before or feels unstable.

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I have a Beighton score of 4 or more, indicating flexible joints.

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I have a fracture in my shoulder area, not including specific shoulder injuries.

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My shoulder injury involves more than 15% of the socket surface.

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I have a nerve injury in my arm.

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I have had surgery on my affected shoulder before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of recurrent shoulder dislocation

Secondary study objectives

Euro-Qol 5 Dimensions Youth

Pediatric and Adolescent Shoulder and Elbow Survey

Rate of adverse events (other than recurrent shoulder dislocations)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Arthroscopic stabilizationActive Control1 Intervention

Patients will have an initial evaluation with a diagnostic shoulder arthroscopy and examination under anesthesia will be performed to confirm the degree of anterior instability and assess range of motion of the affected shoulder. Diagnostic arthroscopy will commence with the use of 3 standard shoulder portals (posterior viewing and two anterior working portals for suture passing), and a detailed arthroscopic examination will be performed. Once the soft tissue tear (including the labrum, and capsule labrum ligaments) is identified, it will be mobilized using a rasp or elevator and a burr will then be used to create a surface for a bleeding bone bed. Capsulolabral repair will then commence with the labrum fixed to the glenoid using suture anchors (the Bankart repair). Following surgery, subjects in this group will follow the same rehabilitation protocol as the comparison group.

Group II: Rehabilitation including a period of immobilization followed by physical therapyActive Control1 Intervention

Subjects in this group will use an internal-rotation shoulder immobilizer, using a standard sling for 6 weeks from the day of enrollment. Subjects will be advised to maintain range of motion (ROM) in the elbow and wrist during this period of time. The immobilizer can be removed for passive pendulum exercises and elbow ROM during the period of immobilization up to 4 times per day. Formal physiotherapy commences at 4 weeks post-enrollment, with a goal of return to activities or sport at 6-months post-enrollment.

0 / 11Eligibility criteria met