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Completed

NCT Number: NCT00196560

Immobilization in External Rotation of Acute Shoulder Dislocations

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.

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Key information

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immobilization in External Rotation

Device

Primary outcomes

  1. Recurrent Instability at 24 months

Secondary outcomes

  1. Time (weeks) to return to work and time(weeks) to return to sport

  2. Complications (resulting from immobilization)

  3. Compliance with immobilization protocol

  4. Western Ontario Shoulder Instability index (WOSI)

  5. American Shoulder and Elbow Surgeons questionnaire (ASES)

Sponsors and collaborators

Lead sponsor

Fowler Kennedy Sport Medicine Clinic

Other

Collaborators

  • American Shoulder and Elbow Surgeons
  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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