Clinical trial NCT04887337: Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode
Official title: Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode (PROMPT): A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Dislocation
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 initial dislocation without surgery, the vast majority of these children and adolescents will, unfortunately continue to have instability episodes of their shoulder. Recurrent instability can cause damage to the bones and cartilage that form the shoulder resulting in potentially more difficult surgical stabilization, and possibly long-term sequela. To that effect, there is increasing interest to consider early surgical stabilization in this population. This pilot randomized controlled trial (RCT) will evaluate the feasibility of conducting a larger RCT assessing the effect of early arthroscopic stabilization compared to rehabilitation on the rate of repeat shoulder dislocations (recurrent instability), pain, and shoulder function among adolescents (aged 12-18 years) with first-time shoulder dislocations. These patients will be followed for one year.


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

Primary outcomes:
measure: Rate of recurrent shoulder dislocation
timeFrame: 12 months
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: 12 months
measure: Pediatric and Adolescent Shoulder and Elbow Survey
timeFrame: 12 months
measure: Euro-Qol 5 Dimensions Youth
timeFrame: 12 months
measure: Rate of adverse events (other than recurrent shoulder dislocations)
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References: