Total Knee ReplacementNCT00755300
Total Knee Arthroplasty And Thromboembolism: A Comparison Between Two Surgical Techniques
An observational study of Total Knee Replacement and Venous Thromboembolism, run by University of California, Davis at 1 site in United States.
Trial summary
In patients undergoing total knee arthroplasty, thromboembolism is a common occurrence, especially following tourniquet deflation. The resulting cardiopulmonary emboli can potentially lead to hypoxemia, hypotension, hemodynamic collapse and post operative cognitive dysfunction due to emboli. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Total Knee Replacement, Venous Thromboembolism
- What is being tested?
- Measurement of total thrombolic load
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jun 2009
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective total knee replacement
Who may be able to join
- Adult patients scheduled to undergo Total Knee Arthroplasty at UC Davis Medical Center
- 18 years and above
Who cannot join
- Any contraindication to perform TEE
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
In patients undergoing total knee arthroplasty, thromboembolism is a common occurrence, especially following tourniquet deflation. The resulting cardiopulmonary emboli can potentially lead to hypoxemia, hypotension, hemodynamic collapse and post operative cognitive dysfunction due to emboli. The standard surgical technique involves placing an intramedullary rod in the femur to determine the angle and degree of resection from the end of the femur. A new surgical technique utilizes computer navigation system to perform the desired cuts in the appropriate position. The investigators hypothesize that the avoidance of intramedullary instrumentation in computer assisted total knee replacement will result in fewer thromboembolic events compared with the standard technique using manual instrumentation in the femur. The present study will test this hypothesis by quantifying the extent of thromboembolism during both surgical techniques.
Read the detailed description
Currently, Transesophageal Echocardiography (TEE) is routinely used intraoperatively to monitor patients undergoing total knee arthroplasty for thromboembolic events. Video recording (without any patient identifiers) of the TEE loops before and after tourniquet release, offline analysis to quantify the extent of thromboembolism and the two surgical techniques will be compared. Patients are assigned to a particular technique according to some non-rigid criteria. This study has no impact on their selection into one group or the other. Participation in this study does not influence the choice/selection. We will simply record and analyze the echo loops in twenty patients already assigned to each surgical technique.
- Conditions
- Total Knee Replacement, Venous Thromboembolism
- Being tested
- Measurement of total thrombolic load
- Keywords
- Total knee replacement, esophageal echocardiography
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of total thrombolic loadProcedure or surgery
A video recording of the right atrium using TE echo will be used to quantitate the total thromboembolic load
| Study group | Role | What they receive |
|---|---|---|
| 1 | Standard Total Knee Replacement Receives: Procedure: Measurement of total thrombolic load | |
| 2 | Computer Guided Knee Replacement Receives: Procedure: Measurement of total thrombolic load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total venous embolic load
Measured: Acute, 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startJun 2006
- Primary completionJun 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Investigators
- Amrik Singh, M.D., Principal investigator, Associate Professor, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755300
- Sponsor's protocol ID
- 200614481
- Status last verified
- Aug 2011
- First submitted
- 17 Sep 2008
- Last updated
- 15 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Arthroplasty And Thromboembolism: A Comparison Between Two Surgical Techniques
- ClinicalTrials.gov ID
- NCT00755300
- Acronym / sponsor ID
- 200614481
- Conditions
- Total Knee Replacement, Venous Thromboembolism
- Keywords
- Total knee replacement, esophageal echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 Sep 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.
In patients undergoing total knee arthroplasty, thromboembolism is a common occurrence, especially following tourniquet deflation. The resulting cardiopulmonary emboli can potentially lead to hypoxemia, hypotension, hemodynamic collapse and post operative cognitive dysfunction due to emboli. The standard surgical technique involves placing an intramedullary rod in the femur to determine the angle and degree of resection from the end of the femur. A new surgical technique utilizes computer navigation system to perform the desired cuts in the appropriate position. The investigators hypothesize that the avoidance of intramedullary instrumentation in computer assisted total knee replacement will result in fewer thromboembolic events compared with the standard technique using manual instrumentation in the femur. The present study will test this hypothesis by quantifying the extent of thromboembolism during both surgical techniques.
Detailed description
Currently, Transesophageal Echocardiography (TEE) is routinely used intraoperatively to monitor patients undergoing total knee arthroplasty for thromboembolic events. Video recording (without any patient identifiers) of the TEE loops before and after tourniquet release, offline analysis to quantify the extent of thromboembolism and the two surgical techniques will be compared. Patients are assigned to a particular technique according to some non-rigid criteria. This study has no impact on their selection into one group or the other. Participation in this study does not influence the choice/selection. We will simply record and analyze the echo loops in twenty patients already assigned to each surgical technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Measurement of total thrombolic loadStandard Total Knee Replacement |
| 2 | – | Procedure: Measurement of total thrombolic loadComputer Guided Knee Replacement |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective total knee replacement
Key inclusion criteria (2 listed)
- Adult patients scheduled to undergo Total Knee Arthroplasty at UC Davis Medical Center
- 18 years and above
Key exclusion criteria (1 listed)
- Any contraindication to perform TEE
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 |
|---|---|---|
| Measurement of total thrombolic loadA video recording of the right atrium using TE echo will be used to quantitate the total thromboembolic load | Procedure or surgery | 1, 2 |
Primary outcome
Total venous embolic load
Time frame: Acute, 5 minutes
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 15 Aug 2011.
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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.
Amrik Singh, M.D. principal investigator
Associate Professor, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
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 Total Knee Replacement and Venous Thromboembolism, run by University of California, Davis 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 2 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 15 Aug 2011. 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.
What does the primary outcome measure?
Total venous embolic load (time frame: Acute, 5 minutes). 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 15 Aug 2011.