Operative Versus Nonoperative Treatment for Scapula Fractures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Vanderbilt University.
Recruitment status was  Recruiting
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
  Purpose

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
Scapula Fracture
Clavicle Fracture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Prospective Study of Operative and Non-operative Treatment for Scapula Fractures

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Estimated Enrollment: 80
Study Start Date: March 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Operative Treatment (Open Reduction Internal Fixation)
2
Non-operative/Conservative Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849771

Contacts
Contact: Julie Agel 612-273-8052 Agelx001@umn.edu

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

No publications provided

Responsible Party: William Obremskey, Chief of Orthopedic Trauma, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00849771     History of Changes
Other Study ID Numbers: 080160
Study First Received: February 20, 2009
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014