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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

PROMPT Trial 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.Check my eligibility
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.See study design
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.

PROMPT Trial 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.

PROMPT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of recurrent shoulder dislocation
Secondary outcome measures
Euro-Qol 5 Dimensions Youth
Pediatric and Adolescent Shoulder and Elbow Survey
Rate of adverse events (other than recurrent shoulder dislocations)
+1 more

PROMPT 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.

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
879 Previous Clinical Trials
2,596,946 Total Patients Enrolled
3 Trials studying Shoulder Dislocation
258 Patients Enrolled for Shoulder Dislocation

Media Library

Arthroscopic Stabilization (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04887337 — N/A
Shoulder Dislocation Research Study Groups: Arthroscopic stabilization, Rehabilitation including a period of immobilization followed by physical therapy
Shoulder Dislocation Clinical Trial 2023: Arthroscopic Stabilization Highlights & Side Effects. Trial Name: NCT04887337 — N/A
Arthroscopic Stabilization (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04887337 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this research permit geriatric participants?

"Qualified volunteers must be between 12 and 18 years old, as specified by the eligibility criteria of this clinical trial."

Answered by AI

What criteria must an individual meet in order to participate in this research?

"This clinical trial is inviting patients between the ages of 12 and 18 with shoulder dislocation to apply. Approximately 30 people will be able to join this study."

Answered by AI

What is the overall count of research participants in this experiment?

"Affirmative. The information hosted on clinicaltrials.gov testifies that this research is presently seeking participants, which were initially posted on September 19th 2022 and was recently updated on the same date. As of now, 30 volunteers are being accepted at a single medical centre."

Answered by AI
~14 spots leftby Jun 2025