Bone to Skin Thickness Study: Obese Versus Normal Population

NCT ID: NCT01248182

Last Updated: 2012-04-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-12-31

Brief Summary

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.

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.

Conditions

Fracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Graves, MD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

University of Mississippi Medical Center

Jackson, Mississippi, United States

Countries

United States

Other Identifiers

2009-0059

Identifier Type: -

Identifier Source: org_study_id