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Bone to Skin Thickness Study: Obese Versus Normal Population

This study has been terminated.
(Study was terminated by investigator)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01248182
First Posted: November 25, 2010
Last Update Posted: April 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stryker Orthopaedics
Information provided by (Responsible Party):
University of Mississippi Medical Center
  Purpose
The purpose of this study is to determine the bone to skin depth for groups of lean, obese and morbidly obese patients. This information will be potentially helpful with implant design for obese and lean patients.

Condition
Fracture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone to Skin Thickness Study: Obese Versus Normal Population

Further study details as provided by University of Mississippi Medical Center:

Enrollment: 21
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Detailed Description:

This study will examine pelvic CT scans of injured patients to determine skin thickness in several distinct regions important in orthopedic surgery. All patients admitted to the University of Mississippi Medical Center with a pelvic ring injury or acetabular fracture obtain a pelvic CT scan as a standard part of patient evaluation. The CT scans attempt to encompass the entire soft tissue sleeve from the skin edge to the pelvic bones. Several landmarks described below have been described to measure important surgical sites where obesity is problematical. Therefore this study is an attempt to quantify the size of the soft tissue envelope in patients

However, patients who are markedly obese may be too large for the entire soft tissue sleeve to be imaged with the CT scan. The second part of the study then is to validate the CT scan measurements obtained using clinical measurements. The clinical measurements will be obtained during operative management of displaced pelvic ring injuries and/or acetabular fractures. During surgical exposure, a measuring tape will be used to measure the soft tissue thickness in those areas corresponding to the CT scan measurements. These measures will be compared to validate the effectiveness of CT scan measurements to accurately document the soft tissue dimensions.

  Eligibility

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
Patients with pelvic ring injury or acetabular fracture
Criteria

Inclusion Criteria:

  • Anyone admitted to the University of Mississippi Medical Center with a pelvic ring or acetabular injury

Exclusion Criteria:

  • Those not fitting the inclusion criteria
  Contacts and Locations
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): NCT01248182


Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Stryker Orthopaedics
Investigators
Principal Investigator: Matthew Graves, MD University of Mississippi Medical Center
  More Information

Responsible Party: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01248182     History of Changes
Other Study ID Numbers: 2009-0059
First Submitted: November 23, 2010
First Posted: November 25, 2010
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by University of Mississippi Medical Center:
acetabular fracture
pelvic ring injury