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

Primary Purpose

Shoulder Dislocation

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Arthroscopic stabilization
Rehabilitation including a period of immobilization followed by physical therapy
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arthroscopic stabilization

Rehabilitation including a period of immobilization followed by physical therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual Analogue Scale
100-point pain scale, range 0-100, higher score indicates worse pain.
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.
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.
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.

Full Information

First Posted
May 6, 2021
Last Updated
October 17, 2023
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT04887337
Brief Title
Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arthroscopic stabilization
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Rehabilitation including a period of immobilization followed by physical therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic stabilization
Intervention Description
Early arthroscopic stabilization with Bankart repair
Intervention Type
Other
Intervention Name(s)
Rehabilitation including a period of immobilization followed by physical therapy
Intervention Description
Rehabilitation including a period of immobilization followed by physical therapy
Primary Outcome Measure Information:
Title
Rate of recurrent shoulder dislocation
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
100-point pain scale, range 0-100, higher score indicates worse pain.
Time Frame
12 months
Title
Pediatric and Adolescent Shoulder and Elbow Survey
Description
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.
Time Frame
12 months
Title
Euro-Qol 5 Dimensions Youth
Description
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.
Time Frame
12 months
Title
Rate of adverse events (other than recurrent shoulder dislocations)
Description
Defined as any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females between the ages of 12 and 18, inclusive Patients with a first-time traumatic anterior glenohumeral dislocation within the past 3 months Anterior glenohumeral dislocation confirmed by radiography, reduction required by medical personnel, or demonstration of anterior apprehension on physical examination following injury to the shoulder MRI or MRA demonstrating disruption of the glenohumeral soft tissues (including the labrum, periosteum, or inferior glenohumeral ligament) relating to instability Patients who have the ability to speak, understand, and read English Provision of informed consent (age 18) or parental consent (ages 12-17, inclusive) Provision of informed child assent (ages 12-17, inclusive) Exclusion Criteria: Previous dislocation episodes or instability of the affected shoulder Previous surgeries involving the affected shoulder History or clinical exam findings of generalized ligamentous laxity (defined as a Beighton score of 4 or more points) History of multi-directional instability of either shoulder Concomitant fracture of the tuberosity, humerus, or glenoid (excluding a Bankart or Hill Sachs lesion) Bony Bankart lesion exceeding 15% of the glenoid surface (using the best-fit circle method on MRI) Hill Sachs lesion exceeding 15% of the humeral diameter (Measured on transaxial slice of MRI similar to Salomonsson et al.) A neurological injury of the affected arm Patients who will likely have problems, in the judgement of the investigator, with maintaining follow-up Any other reason(s) the investigator feels is relevant for excluding the patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Simunovic, MSc
Phone
905-521-2100
Ext
73507
Email
simunon@mcmaster.ca
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Simunovic, MSc
Phone
2892373224
Email
simunon@mcmaster.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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

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