Shoulder Dislocation Clinical Trial
Official title:
Immobilization in External Rotation After First Time Anterior Shoulder Dislocation: A Prospective Randomized Study
NCT number | NCT00707018 |
Other study ID # | 04-0088 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2004 |
Est. completion date | February 2012 |
Verified date | April 2019 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.
Status | Completed |
Enrollment | 50 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 30 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Summa Healthcare | Akron | Ohio |
United States | University of New Mexico | Albuquerque | New Mexico |
United States | CU Sports Medicine | Boulder | Colorado |
United States | Ohio State University | Columbus | Ohio |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Inland Orthopaedics | Pullman | Washington |
United States | St. Anthony Hospitals | Winter Park | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation. | 24 months | ||
Secondary | Patient self reported outcome measures | 24 Months | ||
Secondary | Time to return to work or sport | 24 Months |
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