Memory Disorders, Postoperative Complications
Conditions
Keywords
postoperative cognitive dysfunction, total knee arthroplasty, cerebral emboli, carbon dioxide lavage, pulsatile saline lavage
Brief 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.
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.
Interventions
DEVICEpulsatile saline lavage
Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage
DEVICEcarbon dioxide lavage
Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage
Sponsors
US Department of Veterans Affairs
Kinamed Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 50 years or older who are scheduled for elective TKA with a cemented Smith and Nephew Prosthesis design
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD) | During surgery |
Secondary
| Measure | Time frame |
|---|---|
| Number of Patients With Emboli in the High Category | During surgery |
| Number of Patients With Delirium During Hospital Stay | First 3 days after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Neurocognitive Tests Following Surgery | 3 months following surgery | Hopkins Verbal Learning Test (HVLT).This is a test of verbal learning and memory. The scale is the number of words retained. The total score for the test administered ranges from 0 to 12. Higher values represent better outcomes. |
Countries
United States
Participant flow
Recruitment details
during pre-op workup for TKA, patients were informed about study and asked if they wanted to participate.
Participants by arm
| Arm | Count |
|---|---|
| 1 Pulsatile Saline Lavage pulsatile saline lavage : Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage | 10 |
| 2 Carbon Dioxide Lavage carbon dioxide lavage : Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | 2 Carbon Dioxide Lavage | 1 Pulsatile Saline Lavage | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Continuous | 63.9 years STANDARD_DEVIATION 3.7 | 62.3 years STANDARD_DEVIATION 3.3 | 63.1 years STANDARD_DEVIATION 3.5 |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)
Time frame: During surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Pulsatile Saline Lavage | The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD) | 0 emboli |
| 2 Carbon Dioxide Lavage | The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD) | 3 emboli |
Secondary
Number of Patients With Delirium During Hospital Stay
Time frame: First 3 days after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1 Pulsatile Saline Lavage | Number of Patients With Delirium During Hospital Stay | 1 Participants |
| 2 Carbon Dioxide Lavage | Number of Patients With Delirium During Hospital Stay | 4 Participants |
p-value: >0.05t-test, 2 sided
Secondary
Number of Patients With Emboli in the High Category
Time frame: During surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Pulsatile Saline Lavage | Number of Patients With Emboli in the High Category | 9 Patients w/ emboli in high category |
| 2 Carbon Dioxide Lavage | Number of Patients With Emboli in the High Category | 5 Patients w/ emboli in high category |
Other Pre-specified
Changes in Neurocognitive Tests Following Surgery
Hopkins Verbal Learning Test (HVLT).This is a test of verbal learning and memory. The scale is the number of words retained. The total score for the test administered ranges from 0 to 12. Higher values represent better outcomes.
Time frame: 3 months following surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Pulsatile Saline Lavage | Changes in Neurocognitive Tests Following Surgery | 1.67 score on a scale | Standard Error 1.6 |
| 2 Carbon Dioxide Lavage | Changes in Neurocognitive Tests Following Surgery | 4.7 score on a scale | Standard Error 1.5 |
p-value: >0.05Wilcoxon (Mann-Whitney)