Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode (PROMPT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04887337|
Recruitment Status : Not yet recruiting
First Posted : May 14, 2021
Last Update Posted : May 31, 2022
|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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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.
- Visual Analogue Scale [ Time Frame: 12 months ]100-point pain scale, range 0-100, higher score indicates worse pain.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04887337
|Contact: Nicole Simunovic, MSc||905-521-2100 ext firstname.lastname@example.org|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Contact: Nicole Simunovic, MSc 2892373224 email@example.com|