FractureNCT01248182
Bone to Skin Thickness Study: Obese Versus Normal Population
An observational study of Fracture, run by University of Mississippi Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pelvic ring injury or acetabular fracture
Who may be able to join
- Anyone admitted to the University of Mississippi Medical Center with a pelvic ring or acetabular injury
Who cannot join
- Those not fitting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
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.
Read the 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
- Keywords
- acetabular fracture, pelvic ring injury
- Medical subject headings
- Fractures, Bone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionDec 2011
Why it stopped: Study was terminated by investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Matthew Graves, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248182
- Sponsor's protocol ID
- 2009-0059
- Status last verified
- Apr 2012
- First submitted
- 23 Nov 2010
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone to Skin Thickness Study: Obese Versus Normal Population
- ClinicalTrials.gov ID
- NCT01248182
- Acronym / sponsor ID
- 2009-0059
- Conditions
- Fracture
- Keywords
- acetabular fracture, pelvic ring injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was terminated by investigator
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pelvic ring injury or acetabular fracture
Key inclusion criteria (1 listed)
- Anyone admitted to the University of Mississippi Medical Center with a pelvic ring or acetabular injury
Key exclusion criteria (1 listed)
- Those not fitting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Study was terminated by investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Graves, MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was terminated by investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2012.