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