Bone to Skin Thickness Study: Obese Versus Normal Population

Fracture Clinical Trial

Official title:

Bone to Skin Thickness Study: Obese Versus Normal Population

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01248182
• Other study ID #: 2009-0059
• Status: Terminated
• Phase: N/A
• First received: November 23, 2010
• Last updated: April 5, 2012
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fracture

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	Stryker Orthopaedics

Country where clinical trial is conducted

United States,