Immobilization in External Rotation After First Time Anterior Shoulder Dislocation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00707018
First received: June 26, 2008
Last updated: December 11, 2013
Last verified: January 2013
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient self reported outcome measures [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Time to return to work or sport [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   14 Years to 30 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00707018     History of Changes
Other Study ID Numbers: 04-0088
Study First Received: June 26, 2008
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dislocations
Shoulder Dislocation
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on August 18, 2014