A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparison of Intraoperative Embolic Events During Total Knee Arthroplasty Performed With CarboJet Assisted Versus Standard Orthopedic Techniques: A Pilot Study

Conditions
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Postoperative Complications, Memory Disorders

Intervention / Treatment
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* Device: pulsatile saline lavage
* Device: carbon dioxide lavage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Device: pulsatile saline lavage<br>* Prior to cement application, cut bone surfaces are cleaned using pulsatile saline lavage<br>|
| Active Comparator: 2<br> | Device: carbon dioxide lavage<br>* Prior to cement application, cut bone surfaces are cleaned using carbon dioxide lavage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD) |  | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative cognitive dysfunction, total knee arthroplasty, cerebral emboli, carbon dioxide lavage, pulsatile saline lavage