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Operative Versus Nonoperative Treatment for Scapula Fractures

This study is currently recruiting participants.
Verified August 2012 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
William Obremskey, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00849771
First received: February 20, 2009
Last updated: August 1, 2012
Last verified: August 2012
History of Changes

February 20, 2009
August 1, 2012
March 2008
January 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00849771 on ClinicalTrials.gov Archive Site
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Operative Versus Nonoperative Treatment for Scapula Fractures
Multicenter Prospective Study of Operative and Non-operative Treatment for Scapula Fractures

The purpose of this study is to contrast and evaluate the functional outcome of patients with operative vs. nonoperative treatment of scapula fractures. The specific aim of this project is to monitor the return to function of patients in both the operative and nonoperative cohorts.

The potential impact is a clearer set of choices in treatment options for this type of injury.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

The subject population will include patients seen at participating facilities for the care of scapula fractures, who are 18 years of age or older, meet inclusion/exclusion criteria and are willing to consent.
  • Scapula Fracture
  • Clavicle Fracture
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  • 1
    Operative Treatment (Open Reduction Internal Fixation)
  • 2
    Non-operative/Conservative Care
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 Years of Age or Older
  • Displacement of glenoid neck and scapula body of greater than 2 cm
  • Angular deformity between the fracture fragments of greater than 45 degrees.
  • A combination of displacement greater than 1.5 cm AND angulation greater than 30 degrees
  • A glenopolar angle less than 22 degrees
  • A Double Lesion of the Superior Shoulder Suspensory Complex (SSSC)

Exclusion Criteria:

  • Age Less Than 18 years Old
  • Brachial Plexus Injury
  • Traumatic Brain Injury or Cognitive Disability preventing participation in the consent or post injury rehabilitation
  • Spinal cord injuries resulting in paraplegic, quadriplegic disabilities or permanent ipsilateral peripheral nerve damage
  • Ipsilateral Upper Extremity Injury
  • Previous Shoulder Surgery
  • Insufficient English proficiency to complete the DASH Questionnaire
Both
18 Years and older
No
Contact: Julie Agel 612-273-8052 Agelx001@umn.edu
United States
 
NCT00849771
080160
No
William Obremskey, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: William T. Obremskey, MD, MPH Vanderbilt University
Principal Investigator: Peter Cole, MD University of Minnesota - Clinical and Translational Science Institute
Vanderbilt University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP