Postoperative ComplicationsNCT00736125
A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events
A study testing pulsatile saline lavage and carbon dioxide lavage in people with Postoperative Complications and Memory Disorders, run by Kinamed Incorporated at 1 site in United States.
Trial summary
The purpose of this study is to determine if the use of a carbon dioxide lavage device (CarboJet) to clean bone surfaces during total knee surgery decreases intraoperative embolic events when compared with standard orthopedic techniques. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Postoperative Complications, Memory Disorders
- What is being tested?
- pulsatile saline lavage and carbon dioxide lavage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 50 years or older who are scheduled for elective TKA with a cemented Smith and Nephew Prosthesis design
Who cannot join
- Dementia or severe cognitive impairment
- Severe visual or hearing impairments
- Inability to follow directions or comprehend the English language
- Females who are pregnant
- Abnormal distal femur geometry
- Pre-existing hardware or abnormal bony architecture in the proximal tibia
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Medical Center
Durham, North Carolina, 27705
About this study
Official title: A Comparison of Intraoperative Embolic Events During Total Knee Arthroplasty Performed With CarboJet Assisted Versus Standard Orthopedic Techniques: A Pilot Study
The purpose of this study is to determine if the use of a carbon dioxide lavage device (CarboJet) to clean bone surfaces during total knee surgery decreases intraoperative embolic events when compared with standard orthopedic techniques.
Read the detailed description
Elderly patients undergoing major, orthopedic surgery are at risk of developing postoperative cognitive dysfunction (POCD) or memory impairment following surgery. Transcranial doppler (TCD) monitoring of blood flow to the brain has detected cerebral emboli in 60% of patients following release of the thigh tourniquet during total knee replacement or arthroplasty (TKA). These cerebral embolic events may represent one of the mechanisms responsible for postoperative cognitive problems.
The standard surgical technique for TKA involves cleaning the bone surfaces with pulsed saline lavage prior to cementation and prosthesis insertion. The CarboJet Assisted technique utilizes carbon dioxide lavage to clean and dry the femur canal and bone surfaces prior to cementation and implantation. Because it removes fat globules and marrow particulates from the bone surfaces, it is hypothesized that the use of a carbon dioxide lavage technique in TKA will result in fewer thromboembolic events and increased cement penetration compared with the standard technique using pulsed saline lavage. Cement penetration affects the strength of the bone-cement interface and, therefore, contributes to implant longevity.
- Conditions
- Postoperative Complications, Memory Disorders
- Being tested
- pulsatile saline lavage, carbon dioxide lavage
- Keywords
- postoperative cognitive dysfunction, total knee arthroplasty, cerebral emboli, carbon dioxide lavage, pulsatile saline lavage
- Medical subject headings
- Postoperative Complications, Memory Disorders, Postoperative Cognitive Complications, Intracranial Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsatile saline lavageDevice
Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
carbon dioxide lavageDevice
Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Device: pulsatile saline lavage |
| 2 | Active comparator | Not described Receives: Device: carbon dioxide lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)
Measured: During surgery
Secondary outcomes (2)
Number of Patients With Emboli in the High Category
Measured: During surgery
Number of Patients With Delirium During Hospital Stay
Measured: First 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startDec 2007
- Primary completionSep 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinamed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Terri G Monk, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736125
- Sponsor's protocol ID
- 01226
- Status last verified
- Sep 2019
- First submitted
- 14 Aug 2008
- Last updated
- 26 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Intraoperative Embolic Events During Total Knee Arthroplasty Performed With CarboJet Assisted Versus Standard Orthopedic Techniques: A Pilot Study
- ClinicalTrials.gov ID
- NCT00736125
- Acronym / sponsor ID
- 01226
- Conditions
- Postoperative Complications, Memory Disorders
- Keywords
- postoperative cognitive dysfunction, total knee arthroplasty, cerebral emboli, carbon dioxide lavage, pulsatile saline lavage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kinamed IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- US Department of Veterans Affairs
- Study start
- Dec 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Posted 18 Apr 2013
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 if the use of a carbon dioxide lavage device (CarboJet) to clean bone surfaces during total knee surgery decreases intraoperative embolic events when compared with standard orthopedic techniques.
Detailed description
Elderly patients undergoing major, orthopedic surgery are at risk of developing postoperative cognitive dysfunction (POCD) or memory impairment following surgery. Transcranial doppler (TCD) monitoring of blood flow to the brain has detected cerebral emboli in 60% of patients following release of the thigh tourniquet during total knee replacement or arthroplasty (TKA). These cerebral embolic events may represent one of the mechanisms responsible for postoperative cognitive problems.
The standard surgical technique for TKA involves cleaning the bone surfaces with pulsed saline lavage prior to cementation and prosthesis insertion. The CarboJet Assisted technique utilizes carbon dioxide lavage to clean and dry the femur canal and bone surfaces prior to cementation and implantation. Because it removes fat globules and marrow particulates from the bone surfaces, it is hypothesized that the use of a carbon dioxide lavage technique in TKA will result in fewer thromboembolic events and increased cement penetration compared with the standard technique using pulsed saline lavage. Cement penetration affects the strength of the bone-cement interface and, therefore, contributes to implant longevity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: pulsatile saline lavage |
| 2 | Active comparator | Device: carbon dioxide lavage |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged 50 years or older who are scheduled for elective TKA with a cemented Smith and Nephew Prosthesis design
Key exclusion criteria (6 listed)
- Dementia or severe cognitive impairment
- Severe visual or hearing impairments
- Inability to follow directions or comprehend the English language
- Females who are pregnant
- Abnormal distal femur geometry
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 |
|---|---|---|
| pulsatile saline lavagePrior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage | Device | 1 |
| carbon dioxide lavagePrior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage | Device | 2 |
Primary outcome
The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)
Time frame: During surgery
2 secondary outcomes
Number of Patients With Emboli in the High Category
Time frame: During surgery
Number of Patients With Delirium During Hospital Stay
Time frame: First 3 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Terri G Monk, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsatile saline lavage and carbon dioxide lavage in people with Postoperative Complications and Memory Disorders, run by Kinamed Incorporated 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 6 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 26 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD) (time frame: During surgery). 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 26 Sep 2019.