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

Shoulder Dislocation Clinical Trial

— PROMPT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04887337
• Other study ID #: PROMPT
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: June 1, 2026

Study information

• Verified date: October 2023
• Source: McMaster University
• Contact: Nicole Simunovic, MSc
• Phone: 905-521-2100
• Email: simunon[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

Procedure:
• Arthroscopic stabilization
Early arthroscopic stabilization with Bankart repair

Other:
• Rehabilitation including a period of immobilization followed by physical therapy
Rehabilitation including a period of immobilization followed by physical therapy

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recurrent shoulder dislocation	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.	12 months
Secondary	Visual Analogue Scale	100-point pain scale, range 0-100, higher score indicates worse pain.	12 months
Secondary	Pediatric and Adolescent Shoulder and Elbow Survey	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.	12 months
Secondary	Euro-Qol 5 Dimensions Youth	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.	12 months
Secondary	Rate of adverse events (other than recurrent shoulder dislocations)	Defined as any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study.	12 months