Embolic Events Detected During Total Knee Arthroplasty With the Use of RIA (Reamer-Irrigator-Aspirator)

Study Overview
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Brief Summary
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The embolisation of fat and bone marrow during long bone instrumentation is a well-known complication of major joint replacement surgery. Clinically significant venous thromboembolic disease, cardiopulmonary dysfunction,cerebral emboli, and death have all been described. Because the intravasation of medullary contents is caused by increased pressure during canal instrumentation, the use of the Synthes RIA (Reamer-Irrigator-Aspirator), a negative pressure-irrigated high-speed reamer, may result in a lower incidence of embolism. This controlled clinical trial will evaluate the utility of the RIA in reducing the frequency and severity of embolic events as detected by intraoperative transesophageal echocardiography (TEE) and transcranial Doppler (TCD) during total knee arthroplasty (TKA) surgery.

Detailed Description
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Patients scheduled to undergo total knee replacement surgery will be randomized to receive reaming with either the Synthes RIA (intervention group) or standard reamer (control group). All subjects will undergo intraoperative monitoring with transesophageal echocardiography and transcranial Doppler ultrasound. Both intraoperative and postoperative oxygen saturation levels will be monitored and recorded for evidence of hypoxemia. Subjects will be evaluated for evidence of thrombogenesis and systemic inflammation both preoperatively and at selected postoperative intervals.

Official Title
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Embolic Events Detected During Total Knee Arthroplasty With and Without the Use of RIA (Reamer-Irrigator-Aspirator): A Blinded, Randomized, Controlled Clinical Study

Conditions
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Total Knee Replacement

Intervention / Treatment
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* Procedure: Reaming with Synthes RIA (Reamer-Irrigator-Aspirator)
* Procedure: Reaming with conventional reamer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years of age or older Scheduled or soon to be scheduled for elective total knee replacement surgery No previous history of hip or (ipsilateral) knee replacement Exclusion Criteria: Subject is under 18 Prior instrumentation of the medullary canal (knee or hip) History of esophageal or GI disease or other contraindication for TEE Previous history of DVT Currently on anti-coagulant therapy (i.e. Coumadin or others) Currently on supplemental oxygen or SpO2 is below 90 on room air Cognitive or language barriers limiting comprehension of study materials in English Subject is pregnant or planning pregnancy Current or impending incarceration

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Reaming with Synthes RIA (Reamer-Irrigator-Aspirator) | Procedure: Reaming with Synthes RIA (Reamer-Irrigator-Aspirator)<br>* During knee replacement surgery, the study anesthesiologist will place probes for the transesophageal echocardiogram (TEE) and the transcranial Doppler ultrasound (TCD). In patients randomized to the RIA group (Arm A), surgery performed by the investigating orthopaedic surgeon will be done according to standard of care guidelines up until femoral reaming. These patients will receive reaming with RIA. The remainder of the surgery will also be done according to the standard of care. TEE and TCD data will be recorded throughout the surgery.<br>* Other names: RIA;|
| Active Comparator: B<br>Reaming with conventional reamer | Procedure: Reaming with conventional reamer<br>* During knee replacement surgery, the study anesthesiologist will place probes for the transesophageal echocardiogram (TEE) and the transcranial Doppler ultrasound (TCD). In patients randomized to the control group (Arm B), surgery performed by the investigating orthopaedic surgeon will be done according to standard of care guidelines. These patients will receive reaming with the conventional method/reamer. TEE and TCD data will be recorded throughout the surgery.<br>* Other names: RIA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of intraoperative embolic events detected with transesophageal echocardiography and transcranial Doppler and the grade or size of these embolic events |  | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activation of thrombogenesis and VTE complications, intraoperative and postoperative hypoxemia, and level of systemic inflammation. |  | Post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee replacement surgery, Reamer-Irrigator-Aspirator, femoral reaming, fat embolism