Immobilization in External Rotation of Acute Shoulder Dislocations

A Randomized Evaluation of Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00196560

Enrollment

Registered

2005-09-20

Start date

2003-09-30

Completion date

2007-06-30

Last updated

2015-11-30

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

Conditions

Anterior Shoulder Dislocation

Keywords

Immobilization in External Rotation, Acute primary anterior shoulder dislocation

Brief summary

The purpose of this study is to determine whether immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditional internal rotation) reduces the rate of recurrent dislocations experienced in 24 months.

Detailed description

Immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditional internal rotation)should reduce the rate of recurrent dislocations experienced in 24 months.

Interventions

DEVICEImmobilization in External Rotation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 30 Years

Healthy volunteers

Inclusion criteria

* skeletally mature patients less than 30 years of age * sustained an acute, first-time, traumatic anterior dislocation of the shoulder as defined by; i. Mechanism of abduction, external rotation ii. Sudden pain in the shoulder iii. Manipulative reduction required or iv. Radiograph documenting a dislocated joint * willing to participate in follow-up for at least two years

Exclusion criteria

* incompetent or unwilling to consent * inability or unwillingness to comply with rehabilitative protocol or required follow-up assessments * previous instability of the affected shoulder * significant associated fracture (exception Hill Sachs or Bankart lesions) * concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program * a history of significant ligamentous laxity or demonstrated multi-directional instability of the contralateral shoulder * neurovascular compromise of the affected limb * a medical condition making the patient unable to wear a brace or sling

Design outcomes

Primary

Measure	Time frame
Recurrent Instability at 24 months	—

Secondary

Measure	Time frame
Time (weeks) to return to work and time(weeks) to return to sport	—
Complications (resulting from immobilization)	—
Compliance with immobilization protocol	—
Western Ontario Shoulder Instability index (WOSI)	—
American Shoulder and Elbow Surgeons questionnaire (ASES)	—

Countries

Canada

Outcome results

None listed

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