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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
November 23, 2010
November 25, 2010
April 6, 2012
September 2010
September 2011   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01248182 on ClinicalTrials.gov Archive Site
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Bone to Skin Thickness Study: Obese Versus Normal Population
Bone to Skin Thickness Study: Obese Versus Normal Population
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients with pelvic ring injury or acetabular fracture
Fracture
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
December 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01248182
2009-0059
No
Not Provided
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University of Mississippi Medical Center
University of Mississippi Medical Center
Stryker Orthopaedics
Principal Investigator: Matthew Graves, MD University of Mississippi Medical Center
University of Mississippi Medical Center
April 2012