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Teen shoulder dislocation study halted after only 2 participants

NCT ID NCT04887337

Disease control Sponsor: McMaster University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if early surgery could prevent repeat shoulder dislocations in teenagers better than rehabilitation alone. It planned to enroll adolescents aged 12-18 who had a first-time shoulder dislocation. However, the study was stopped early after only 2 participants, so no conclusions can be drawn.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

2 people

The number who actually took part.

Started

Sep 2022

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Shoulder Dislocation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Shoulder dislocation

Contacts and locations

Locations

  • McMaster University

    Hamilton, Ontario, L8N 3Z5, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.