Shoulder Dislocation
Conditions
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.
Interventions
PROCEDUREArthroscopic stabilization
Early arthroscopic stabilization with Bankart repair
Rehabilitation including a period of immobilization followed by physical therapy
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of recurrent shoulder dislocation | 12 months | Recurrent shoulder dislocations will be defined as an episode of repeat anterior shoulder dislocation either requiring reduction by medical personnel, an x-ray confirming anterior dislocation of the shoulder, or the requirement of surgical management of recurrent instability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | 12 months | 100-point pain scale, range 0-100, higher score indicates worse pain. |
| Pediatric and Adolescent Shoulder and Elbow Survey | 12 months | The Pediatric and Adolescent Shoulder and Elbow Survey has recently been adopted as a shoulder and elbow function scale designed specifically for children and adolescents aged 10-18, and has shown to be well received and understood in this age group. The total score - 100 maximum points - is weighted 50% for pain and 50% for function. |
| Euro-Qol 5 Dimensions Youth | 12 months | The Euro-Qol 5 Dimensions Youth comprises 5 dimensions of health (mobility, self-care \[looking after myself\], usual activities, pain/discomfort, and anxiety/depression \[feeling worried, sad or unhappy\]). Score range 0-100, higher score indicating worse outcomes. |
| Rate of adverse events (other than recurrent shoulder dislocations) | 12 months | Defined as any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. |
Countries
Canada
Outcome results
None listed