Immobilization in External Rotation After First Time Anterior Shoulder Dislocation

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT00707018
• Collaborator: (none)
• Enrollment: 50
• Locations: 8
• Arms: 2
• Duration (Months): 89
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Dislocation	Device: External rotation shoulder sling; Device: Internal rotation shoulder sling	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• 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
• Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation. [24 months]

Secondary Outcome Measures

1. Patient self reported outcome measures [24 Months]

2. Time to return to work or sport [24 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	CU Sports Medicine	Boulder	Colorado	United States	80304
2	St. Anthony Hospitals	Winter Park	Colorado	United States	80482
3	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
4	University of New Mexico	Albuquerque	New Mexico	United States	87131
5	Summa Healthcare	Akron	Ohio	United States	44310
6	Ohio State University	Columbus	Ohio	United States	43221
7	Vanderbilt University	Nashville	Tennessee	United States	37212
8	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT00707018
• Other Study ID Numbers: 04-0088
• First Posted: Jun 30, 2008
• Last Update Posted: Apr 18, 2019
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Joint Dislocations; Shoulder Dislocation

Study Results

No Results Posted as of Apr 18, 2019