Immobilization in External Rotation After First Time Anterior Shoulder Dislocation

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

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

Study Overview

• Status: Completed
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Device: External rotation shoulder sling; Device: Internal rotation shoulder sling

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80304
      • CU Sports Medicine
    • Winter Park, Colorado, United States, 80482
      • St. Anthony Hospitals
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
  • Ohio
    • Akron, Ohio, United States, 44310
      • Summa Healthcare
    • Columbus, Ohio, United States, 43221
      • Ohio State University
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University
  • Washington
    • Pullman, Washington, United States, 99163
      • Inland Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation.	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient self reported outcome measures	24 Months
Time to return to work or sport	24 Months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Eric C McCarty, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: June 26, 2008
• First Submitted That Met QC Criteria: June 27, 2008
• First Posted (Estimate): June 30, 2008

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: 04-0088

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No