Immobilization in External Rotation After First Time Anterior Shoulder Dislocation

NCT00707018 | Completed

• 1 other identifier: 04-0088
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Shoulder Dislocation

Outcome Measures

Primary Outcomes (1)

• Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation.

  24 months

Secondary Outcomes (2)

• Patient self reported outcome measures

  24 Months

• Time to return to work or sport

  24 Months

Study Arms (2)

External rotation shoulder sling

EXPERIMENTAL

External rotation shoulder sling

Device: External rotation shoulder sling

Internal rotation shoulder sling

ACTIVE COMPARATOR

Internal rotation shoulder sling

Device: Internal rotation shoulder sling

Interventions

External rotation shoulder sling DEVICE

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.

External rotation shoulder sling

Internal rotation shoulder sling DEVICE

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.

Internal rotation shoulder sling

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (8)

CU Sports Medicine

Boulder, Colorado, 80304, United States

Location

St. Anthony Hospitals

Winter Park, Colorado, 80482, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Summa Healthcare

Akron, Ohio, 44310, United States

Location

Ohio State University

Columbus, Ohio, 43221, United States

Location

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

Inland Orthopaedics

Pullman, Washington, 99163, United States

Location

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Eric C McCarty, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: September 1, 2004
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (8)