ClinConnect ClinConnect Logo
Search / Trial NCT04887337

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

Launched by MCMASTER UNIVERSITY · May 10, 2021

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the best way to treat adolescents who have had a shoulder dislocation for the first time. Each year, thousands of young people experience this kind of injury, and while many are treated without surgery, many will go on to have repeated dislocations. This can lead to further damage to the shoulder, making future treatment more complicated. The trial aims to compare two approaches: one group will have early surgery to stabilize the shoulder, while the other group will go through rehabilitation (physical therapy) to help their shoulder heal. The researchers want to see which method helps reduce the chances of repeated dislocations, pain, and improves overall shoulder function over the course of a year.

To be eligible for the trial, participants must be between 12 and 18 years old and have experienced a first-time shoulder dislocation within the last three months. They also need to have confirmation of their injury through medical exams or imaging tests. The trial is currently recruiting participants, and those who join will be closely monitored throughout the year to track their recovery and any shoulder issues. This study is important because it could help determine if early surgery is a better option for young people facing this common injury.

Gender

ALL

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

About Mcmaster University

McMaster University, a leading research institution located in Hamilton, Ontario, Canada, is renowned for its innovative approach to education and its commitment to advancing healthcare through rigorous clinical research. The university's diverse research programs are supported by a multidisciplinary team of experts dedicated to improving patient outcomes and public health. With a strong emphasis on evidence-based medicine, McMaster University actively engages in clinical trials that explore new therapies, interventions, and health technologies, fostering collaboration among researchers, healthcare professionals, and industry partners to translate findings into real-world applications.

Locations

Hamilton, Ontario, Canada

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials