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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2019
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

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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