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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
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation

Eligibility Criteria

14 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 26, 2008
Last Updated
April 16, 2019
Sponsor
University of Colorado, Denver
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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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