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

• ClinicalTrials.gov Identifier: NCT04887337
• Recruitment Status: Not yet recruiting
• First Posted: May 14, 2021
• Last Update Posted: May 31, 2022
• Sponsor: McMaster University
• Information provided by (Responsible Party): McMaster University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Shoulder Dislocation	Procedure: Arthroscopic stabilization; Other: Rehabilitation including a period of immobilization followed by physical therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: June 30, 2022
• Estimated Primary Completion Date: June 30, 2025
• Estimated Study Completion Date: June 1, 2026

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arthroscopic stabilization; Patients will have an initial evaluation with a diagnostic shoulder arthroscopy and examination under anesthesia will be performed to confirm the degree of anterior instability and assess range of motion of the affected shoulder. Diagnostic arthroscopy will commence with the use of 3 standard shoulder portals (posterior viewing and two anterior working portals for suture passing), and a detailed arthroscopic examination will be performed. Once the soft tissue tear (including the labrum, and capsule labrum ligaments) is identified, it will be mobilized using a rasp or elevator and a burr will then be used to create a surface for a bleeding bone bed. Capsulolabral repair will then commence with the labrum fixed to the glenoid using suture anchors (the Bankart repair). Following surgery, subjects in this group will follow the same rehabilitation protocol as the comparison group.	Procedure: Arthroscopic stabilization; Early arthroscopic stabilization with Bankart repair
Active Comparator: Rehabilitation including a period of immobilization followed by physical therapy; Subjects in this group will use an internal-rotation shoulder immobilizer, using a standard sling for 6 weeks from the day of enrollment. Subjects will be advised to maintain range of motion (ROM) in the elbow and wrist during this period of time. The immobilizer can be removed for passive pendulum exercises and elbow ROM during the period of immobilization up to 4 times per day. Formal physiotherapy commences at 4 weeks post-enrollment, with a goal of return to activities or sport at 6-months post-enrollment.	Other: Rehabilitation including a period of immobilization followed by physical therapy; Rehabilitation including a period of immobilization followed by physical therapy

Outcome Measures

Primary Outcome Measures :

1. Rate of recurrent shoulder dislocation [ Time Frame: 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 Outcome Measures :

1. Visual Analogue Scale [ Time Frame: 12 months ]
   100-point pain scale, range 0-100, higher score indicates worse pain.
2. Pediatric and Adolescent Shoulder and Elbow Survey [ Time Frame: 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.
3. Euro-Qol 5 Dimensions Youth [ Time Frame: 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.
4. Rate of adverse events (other than recurrent shoulder dislocations) [ Time Frame: 12 months ]
   Defined as any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Nicole Simunovic, MSc; 905-521-2100 ext 73507; simunon@mcmaster.ca

Locations

Canada, Ontario

McMaster University

Hamilton, Ontario, Canada, L8N 3Z5

Contact: Nicole Simunovic, MSc 2892373224 simunon@mcmaster.ca

Sponsors and Collaborators

McMaster University

More Information

• Responsible Party: McMaster University
• ClinicalTrials.gov Identifier: NCT04887337
• Other Study ID Numbers: PROMPT
• First Posted: May 14, 2021
• Last Update Posted: May 31, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Joint Dislocations; Shoulder Dislocation; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries