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Operative Versus Nonoperative Treatment for Scapula Fractures

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ClinicalTrials.gov Identifier: NCT00849771
Recruitment Status : Withdrawn (Joined another larger group of same study)
First Posted : February 24, 2009
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
William Obremskey, Vanderbilt University

Brief Summary:

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.


Condition or disease
Scapula Fracture Clavicle Fracture

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Prospective Study of Operative and Non-operative Treatment for Scapula Fractures
Study Start Date : March 2008
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Group/Cohort
1
Operative Treatment (Open Reduction Internal Fixation)
2
Non-operative/Conservative Care




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849771


Locations
United States, Tennessee
Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-8774
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: William T. Obremskey, MD, MPH Vanderbilt University Medical Center
Principal Investigator: Peter Cole, MD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: William Obremskey, Chief of Orthopedic Trauma, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00849771     History of Changes
Other Study ID Numbers: 080160
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Keywords provided by William Obremskey, Vanderbilt University:
Displaced Scapula Fracture
Scapula Fracture
Extraarticular Scapula Fractures
Clavicle

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries