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CompletedNCT00707018Updated Apr 18, 2019

Immobilization in External Rotation After First Time Anterior Shoulder Dislocation

An interventional study of External rotation shoulder sling and Internal rotation shoulder sling in Shoulder Dislocation, sponsored by University of Colorado, Denver. Completed at 8 sites in United States. Open to participants aged 14 Years to 30 Years. Per ClinicalTrials.gov, last updated 2019-04-18.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
14 Years to 30 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Shoulder Dislocation
03

In context

Joint Dislocations

190 studies on the registry are indexed under Joint Dislocations; 39 are open to participants now.

This study's enrollment of 50 is close to the median of 53 across 120 interventional studies indexed under Joint Dislocations.

Browse Joint Dislocations studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    External rotation shoulder sling

    External rotation shoulder sling

    Device: External rotation shoulder sling

  • Active comparator
    Internal rotation shoulder sling

    Internal rotation shoulder sling

    Device: Internal rotation shoulder sling

Interventions

  • DeviceExternal 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.

  • DeviceInternal 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.

06

What researchers measure

Primary outcomes

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

    Time frame: 24 months

Secondary outcomes

  1. Patient self reported outcome measures

    Time frame: 24 Months

  2. Time to return to work or sport

    Time frame: 24 Months

07

Study locations

8 sites
  • CU Sports Medicine
    Boulder, Colorado 80304, United States
  • St. Anthony Hospitals
    Winter Park, Colorado 80482, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • University of New Mexico
    Albuquerque, New Mexico 87131, United States
  • Summa Healthcare
    Akron, Ohio 44310, United States
  • Ohio State University
    Columbus, Ohio 43221, United States
  • Vanderbilt University
    Nashville, Tennessee 37212, United States
  • Inland Orthopaedics
    Pullman, Washington 99163, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00707018
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Jun 30, 2008
Start date
Sep 2004
Primary completion
Feb 2012
Completion
Feb 2012
Last update
Apr 18, 2019

Study contacts

Eric C McCarty, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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