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Immobilization in External Rotation After First Time Anterior Shoulder Dislocation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00707018
Enrollment
50
Registered
2008-06-30
Start date
2004-09-30
Completion date
2012-02-29
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Dislocation

Brief summary

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

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.

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.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 30 Years
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

* 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.

Design outcomes

Primary

MeasureTime frame
Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation.24 months

Secondary

MeasureTime frame
Patient self reported outcome measures24 Months
Time to return to work or sport24 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026