Immobilization in External Rotation After First Time Anterior Shoulder Dislocation

Shoulder Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707018
• Other study ID #: 04-0088
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Shoulder Dislocation

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