Femur FractureNCT00919464
Natural History of Anterior Compartment Pressures of the Thigh Following Femur Fracture
A study testing Pressure monitoring device, Compartmental fracture pressure monitoring and This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture in people with Femur Fracture, run by CAMC Health System.
Trial summary
This study is to determine the natural history of compartment pressures in the anterior thigh secondary to a fracture of the femoral shaft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fracture
- What is being tested?
- Pressure monitoring device, Compartmental fracture pressure monitoring and This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Jan 2010
- Phase
- Interventional
- 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
Who may be able to join
- femur fracture
- age 18 and older
Who cannot join
- patients who are not candidates for surgical repair of femur fracture
- patients not expected to survive more than 1 week
About this study
Official title: Natural History of Anterior Compartment Pressures of the Thigh Following Femur
This study is to determine the natural history of compartment pressures in the anterior thigh secondary to a fracture of the femoral shaft.
Read the detailed description
Compartment syndrome is a painful condition where increased tissue pressure in a restricted area compromises circulation and endangers the tissue within that area possibly leading to surgery, amputation, major loss of function and in rare cases, death. Compartment syndrome of the thigh can be particularly devastating because of the size of the muscle and large amount of blood flow to the area, however it is one of the more rare and therefore least understood of all compartment syndromes. The purpose of this study is to determine the natural history of pressures of the anterior compartment of the thigh following femur fracture, which could help elucidate the diagnostic and treatment algorithms for thigh compartment syndrome. This small project is designed to be a non-randomized, investigational prospective trail to be conducted at the General Division of Charleston Area Medical Center. The target population consists of males and non-pregnant females age 18 and over who have suffered a mid-shaft femur fracture.
- Conditions
- Femur Fracture
- Being tested
- Pressure monitoring device, Compartmental fracture pressure monitoring, This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture
- Keywords
- Compartment pressure, compartment syndrome, femur fracture
- Medical subject headings
- Femoral Fractures, Compartment Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure monitoring deviceDevice
monitoring device inserted to measure thigh compartment pressures
Compartmental fracture pressure monitoringDevice
This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fractureDevice
| Study group | Role | What they receive |
|---|---|---|
| Needle Insertion into Femur | Other | Data gathering with monitoring of pressures in the thigh via via needle in femur. Receives: Device: Pressure monitoring device; Device: Compartmental fracture pressure monitoring; Device: This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compartment pressures
Measured: Pre-operative to 50 hours post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startApr 2006
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Whitler, BS, CAMC Health System
- Investigators
- John DeLuca, MD, Principal investigator, WVU Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919464
- Sponsor's protocol ID
- 06-04-1803
- Status last verified
- Mar 2020
- First submitted
- 9 Jun 2009
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Anterior Compartment Pressures of the Thigh Following Femur
- ClinicalTrials.gov ID
- NCT00919464
- Acronym / sponsor ID
- 06-04-1803
- Conditions
- Femur Fracture
- Keywords
- Compartment pressure, compartment syndrome, femur fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 Jun 2009 (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.
This study is to determine the natural history of compartment pressures in the anterior thigh secondary to a fracture of the femoral shaft.
Detailed description
Compartment syndrome is a painful condition where increased tissue pressure in a restricted area compromises circulation and endangers the tissue within that area possibly leading to surgery, amputation, major loss of function and in rare cases, death. Compartment syndrome of the thigh can be particularly devastating because of the size of the muscle and large amount of blood flow to the area, however it is one of the more rare and therefore least understood of all compartment syndromes. The purpose of this study is to determine the natural history of pressures of the anterior compartment of the thigh following femur fracture, which could help elucidate the diagnostic and treatment algorithms for thigh compartment syndrome. This small project is designed to be a non-randomized, investigational prospective trail to be conducted at the General Division of Charleston Area Medical Center. The target population consists of males and non-pregnant females age 18 and over who have suffered a mid-shaft femur fracture.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Needle Insertion into Femur | Other | Device: Pressure monitoring device, Device: Compartmental fracture pressure monitoring, Device: This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fractureData gathering with monitoring of pressures in the thigh via via needle in femur. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- femur fracture
- age 18 and older
Key exclusion criteria (2 listed)
- patients who are not candidates for surgical repair of femur fracture
- patients not expected to survive more than 1 week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure monitoring devicemonitoring device inserted to measure thigh compartment pressures | Device | Needle Insertion into Femur |
| Compartmental fracture pressure monitoring | Device | Needle Insertion into Femur |
| This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture | Device | Needle Insertion into Femur |
Primary outcome
Compartment pressures
Time frame: Pre-operative to 50 hours post operation
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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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.
John DeLuca, MD principal investigator
WVU Department of Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Pressure monitoring device, Compartmental fracture pressure monitoring and This small project is designed to be a non-randomized, investigational prospective trial of compartment pressures in the thigh following femoral fracture in people with Femur Fracture, run by CAMC Health System.
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 2 inclusion and 2 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 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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: low enrollment). 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.
What does the primary outcome measure?
Compartment pressures (time frame: Pre-operative to 50 hours post operation). It is what the study was designed to measure, not a finding.
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 4 Mar 2020.