Operative Versus Nonoperative Treatment for Scapula Fractures

This study is currently recruiting participants.

Verified by Vanderbilt University, June 2009

First Received: February 20, 2009 Last Updated: June 5, 2009 History of Changes

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00849771

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:	Cohort, Prospective
Official Title:	Multicenter Prospective Study of Operative and Non-Operative Treatment for Scapula Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Contacts

Contact: Robin E Driver, RN	615-936-3312	robin.e.driver@vanderbilt.edu
Contact: Robin E Driver, RN	615-944-6328	robin.e.driver@vanderbilt.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
Sub-Investigator: Philip J. Kregor, MD
Sub-Investigator: Marc Tressler, DO
Sub-Investigator: Erica Mitchell, MD
Sub-Investigator: Kurtis Staples, MD

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

William T. Obremskey, MD, MPH

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt University ( William T. Obremskey, MD, MPH )
Study ID Numbers:	080160
Study First Received:	February 20, 2009
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00849771 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Displaced Scapula Fracture
Scapula Fracture
Extraarticular Scapula Fractures
Clavicle

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on August 30, 2009