Fat Embolism SyndromeFat EmbolismNCT00656877
Incidence of Fat Embolism With Computer Assisted Total Knee Arthroplasty
An observational study of Fat Embolism Syndrome, run by Marshall University at 1 site in United States.
Trial summary
The study to determine the if the incidence of Fat Embolism is decreased using Computer Assisted technology when performing a Total Knee Arthroplasty. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fat Embolism Syndrome
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Mar 2008
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who are deemed candidates for Computer Assisted Total Knee Arthroplasty
Who may be able to join
- Must be a candidate for Computer Assisted Total Knee Arthroplasty
Who cannot join
- Mentally incompetent patients excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Marshall University School Of Medicine, Department of Orthopaedics
Huntington, West Virginia, 25701
About this study
The study to determine the if the incidence of Fat Embolism is decreased using Computer Assisted technology when performing a Total Knee Arthroplasty.
Read the detailed description
Computer assisted total knee arthroplasty is at its inception currently. There are many unknowns about this specific technique, particularly when it comes down to fat embolism syndrome. There is a high incidence of fat embolism during total knee arthroplasty as seen both by echocariography as well as sampling of right atrial blood. During a jig-based, or traditional, total knee arthroplasty, a rod is placed inside the femur, and sometimes the tibia as well. Intrusumentations of the medullary canal is known to cause fat embolism. Fat embolism is a syndrome which can produce post-operative confusion, hypoxemia, all the way to post-op and intra-operative death.
Computer assisted total knee arthroplasty does not use intramedullary jigs. It is presumed that by not instrumenting the medullary canal, the rate of fat embolism will be significantly reduced.
Fifty patient s will be studied while they are having a computer assisted total knee arthoplasty. A PICC line will be placed in their arm by an interventional radiologist pre-operatively. This PICC line will be thread into the right atrium. Right atrial blood will be sent to pathology every 10 minutes during the 60 to 90 minute procedure and at intervals post-op. The right atrial blood will be stained for bone marrow elements.
This study is to presumed to show yet another benefit of computer assisted surgery.
- Conditions
- Fat Embolism Syndrome
- Keywords
- Fat Embolism Total Knee Arthroplasty
- Medical subject headings
- Embolism, Fat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startJan 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat Embolism SyndromeStudies 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
- Case only
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Investigators
- Ali Oliashirazi, MD, Principal investigator, Marshall University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656877
- Sponsor's protocol ID
- 6077
- Acronym
- Fat Embolism
- Status last verified
- Apr 2008
- First submitted
- 27 Dec 2007
- Last updated
- 11 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Fat Embolism With Computer Assisted Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00656877
- Acronym / sponsor ID
- Fat Embolism / 6077
- Conditions
- Fat Embolism Syndrome
- Keywords
- Fat Embolism Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 11 Apr 2008 (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 study to determine the if the incidence of Fat Embolism is decreased using Computer Assisted technology when performing a Total Knee Arthroplasty.
Detailed description
Computer assisted total knee arthroplasty is at its inception currently. There are many unknowns about this specific technique, particularly when it comes down to fat embolism syndrome. There is a high incidence of fat embolism during total knee arthroplasty as seen both by echocariography as well as sampling of right atrial blood. During a jig-based, or traditional, total knee arthroplasty, a rod is placed inside the femur, and sometimes the tibia as well. Intrusumentations of the medullary canal is known to cause fat embolism. Fat embolism is a syndrome which can produce post-operative confusion, hypoxemia, all the way to post-op and intra-operative death.
Computer assisted total knee arthroplasty does not use intramedullary jigs. It is presumed that by not instrumenting the medullary canal, the rate of fat embolism will be significantly reduced.
Fifty patient s will be studied while they are having a computer assisted total knee arthoplasty. A PICC line will be placed in their arm by an interventional radiologist pre-operatively. This PICC line will be thread into the right atrium. Right atrial blood will be sent to pathology every 10 minutes during the 60 to 90 minute procedure and at intervals post-op. The right atrial blood will be stained for bone marrow elements.
This study is to presumed to show yet another benefit of computer assisted surgery.
Study design
- Observational model
- Case only
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are deemed candidates for Computer Assisted Total Knee Arthroplasty
Key inclusion criteria (1 listed)
- Must be a candidate for Computer Assisted Total Knee Arthroplasty
Key exclusion criteria (1 listed)
- Mentally incompetent patients excluded
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2008.
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.
Ali Oliashirazi, MD principal investigator
Marshall University
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 Fat Embolism Syndrome, run by Marshall University 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: finished, as of the sponsor's last update on 11 Apr 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 11 Apr 2008.