Status:
TERMINATED
Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode
Lead Sponsor:
McMaster University
Conditions:
Shoulder Dislocation
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Males and females between the ages of 12 and 18, inclusive
- Patients with a first-time traumatic anterior glenohumeral dislocation within the past 3 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) relating to instability
- Patients who have the ability to speak, understand, and read English
- Provision of informed consent (age 18) or parental consent (ages 12-17, inclusive)
- Provision of informed child assent (ages 12-17, inclusive)
Exclusion
- 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)
- 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)
- Hill Sachs lesion exceeding 15% of the humeral diameter (Measured on transaxial slice of MRI similar to Salomonsson et al.)
- 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
Key Trial Info
Start Date :
September 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2025
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04887337
Start Date
September 19 2022
End Date
October 24 2025
Last Update
November 26 2025
Active Locations (1)
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1
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5