Embolic Events Detected During Total Knee Arthroplasty With the Use of RIA (Reamer-Irrigator-Aspirator)
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Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
6 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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