Immobilization in External Rotation After First Time Anterior Shoulder Dislocation - Full Text View

Purpose

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.

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

MedlinePlus related topics:

Dislocations Shoulder Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment

Official Title:	Immobilization in External Rotation After First Time Anterior Shoulder Dislocation: A Prospective Randomized Study

Further study details as provided by University of Colorado at Denver and Health Sciences Center:

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 ]

Estimated Enrollment:	50
Study Start Date:	September 2004
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707018

Contacts


Contact: Eric C McCarty, MD	303-441-2219

Locations


United States, Colorado
	CU Sports Medicine	Recruiting
	Boulder, Colorado, United States, 80304
	Contact: Eric C McCarty, MD 303-441-2175 eric.mccarty@uchsc.edu
	Principal Investigator: Eric C McCarty, MD
	Sub-Investigator: Armando F Vidal, MD
	St. Anthony Hospitals	Recruiting
	Winter Park, Colorado, United States, 80482

United States, Iowa
	University of Iowa Hospitals and Clinics	Recruiting
	Iowa City, Iowa, United States, 52242

United States, New Mexico
	University of New Mexico	Recruiting
	Albuquerque, New Mexico, United States, 87131

United States, Ohio
	Summa Healthcare	Recruiting
	Akron, Ohio, United States, 44310
	Ohio State University	Recruiting
	Columbus, Ohio, United States, 43221

United States, Tennessee
	Vanderbilt University	Recruiting
	Nashville, Tennessee, United States, 37212

United States, Washington
	Inland Orthopaedics	Recruiting
	Pullman, Washington, United States, 99163

Sponsors and Collaborators

University of Colorado at Denver and Health Sciences Center

Investigators


Principal Investigator:	Eric C McCarty, MD	University of Colorado at Denver and Health Sciences Center

More Information

Responsible Party:	University of Colorado Denver and Health Sciences Center ( Eric C McCarty/Associate Professor )
Study ID Numbers:	04-0088, 05-018
First Received:	June 26, 2008
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00707018
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Dislocations

Wounds and Injuries

Shoulder Dislocation

Disorders of Environmental Origin

Arm Injuries

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	University of Colorado at Denver and Health Sciences Center
Information provided by:	University of Colorado at Denver and Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00707018