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Immobilization in External Rotation After First Time Anterior Shoulder Dislocation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00707018
First Posted: June 30, 2008
Last Update Posted: May 24, 2016
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. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.

Condition Intervention Phase
Shoulder Dislocation Device: External rotation shoulder sling Device: Internal rotation shoulder sling Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immobilization in External Rotation After First Time Anterior Shoulder Dislocation: A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation. [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Patient self reported outcome measures [ Time Frame: 24 Months ]
  • Time to return to work or sport [ Time Frame: 24 Months ]

Enrollment: 50
Study Start Date: September 2004
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: External rotation shoulder sling
External rotation shoulder sling
Device: External rotation shoulder sling
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.
Active Comparator: Internal rotation shoulder sling
Internal rotation shoulder sling
Device: Internal rotation shoulder sling
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.

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.
  Eligibility

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Ages Eligible for Study:   14 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00707018


Locations
United States, Colorado
CU Sports Medicine
Boulder, Colorado, United States, 80304
St. Anthony Hospitals
Winter Park, Colorado, United States, 80482
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Ohio
Summa Healthcare
Akron, Ohio, United States, 44310
Ohio State University
Columbus, Ohio, United States, 43221
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
United States, Washington
Inland Orthopaedics
Pullman, Washington, United States, 99163
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Eric C McCarty, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00707018     History of Changes
Other Study ID Numbers: 04-0088
First Submitted: June 26, 2008
First Posted: June 30, 2008
Last Update Posted: May 24, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Joint Dislocations
Shoulder Dislocation
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries