Immobilization in External Rotation After First Time Anterior Shoulder Dislocation
Primary Purpose
Shoulder Dislocation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
External rotation shoulder sling
Internal rotation shoulder sling
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Dislocation
Eligibility Criteria
Inclusion Criteria:
- 14 to 30 years of age
- Willing to participate in follow-up for at least two years
- Acute, first-time, traumatic, isolated anterior dislocation of the shoulder
Exclusion Criteria:
- Previous instability of the affected shoulder
- A history of significant ligamentous laxity or demonstrated multi-directional instability of the opposite shoulder
- Inability or unwillingness to comply with sling immobilization, rehabilitative protocol, or required follow-up assessments
- Incompetent or unwilling to consent
- A medical condition making the patient unable to wear a sling
- Significant associated fracture (Exception Hill Sachs of >20% or bony Bankart lesions>10%)
- Neurovascular compromise of the affected limb
- Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program.
Sites / Locations
- CU Sports Medicine
- St. Anthony Hospitals
- University of Iowa Hospitals and Clinics
- University of New Mexico
- Summa Healthcare
- Ohio State University
- Vanderbilt University
- Inland Orthopaedics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
External rotation shoulder sling
Internal rotation shoulder sling
Arm Description
External rotation shoulder sling
Internal rotation shoulder sling
Outcomes
Primary Outcome Measures
Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation.
Secondary Outcome Measures
Patient self reported outcome measures
Time to return to work or sport
Full Information
NCT ID
NCT00707018
First Posted
June 26, 2008
Last Updated
April 16, 2019
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT00707018
Brief Title
Immobilization in External Rotation After First Time Anterior Shoulder Dislocation
Official Title
Immobilization in External Rotation After First Time Anterior Shoulder Dislocation: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.
Detailed Description
The purpose of this study is to compare immobilization in internal versus external rotation after first time anterior shoulder dislocation, and thereby increase our knowledge about the best standard of care.
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
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
External rotation shoulder sling
Arm Type
Experimental
Arm Description
External rotation shoulder sling
Arm Title
Internal rotation shoulder sling
Arm Type
Active Comparator
Arm Description
Internal rotation shoulder sling
Intervention Type
Device
Intervention Name(s)
External rotation shoulder sling
Intervention Description
The external rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 10 to 15 degrees of external rotation at the shoulder.
Intervention Type
Device
Intervention Name(s)
Internal rotation shoulder sling
Intervention Description
The internal rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 70 to 80 degrees of internal rotation at the shoulder.
Primary Outcome Measure Information:
Title
Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Patient self reported outcome measures
Time Frame
24 Months
Title
Time to return to work or sport
Time Frame
24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
14 to 30 years of age
Willing to participate in follow-up for at least two years
Acute, first-time, traumatic, isolated anterior dislocation of the shoulder
Exclusion Criteria:
Previous instability of the affected shoulder
A history of significant ligamentous laxity or demonstrated multi-directional instability of the opposite shoulder
Inability or unwillingness to comply with sling immobilization, rehabilitative protocol, or required follow-up assessments
Incompetent or unwilling to consent
A medical condition making the patient unable to wear a sling
Significant associated fracture (Exception Hill Sachs of >20% or bony Bankart lesions>10%)
Neurovascular compromise of the affected limb
Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric C McCarty, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
CU Sports Medicine
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
St. Anthony Hospitals
City
Winter Park
State/Province
Colorado
ZIP/Postal Code
80482
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Summa Healthcare
City
Akron
State/Province
Ohio
ZIP/Postal Code
44310
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Inland Orthopaedics
City
Pullman
State/Province
Washington
ZIP/Postal Code
99163
Country
United States
12. IPD Sharing Statement
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Immobilization in External Rotation After First Time Anterior Shoulder Dislocation
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