Clinical trial NCT00815958: Embolic Events Detected During Total Knee Arthroplasty With the Use of RIA (Reamer-Irrigator-Aspirator)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Total Knee Replacement
Keywords: knee replacement surgery
Reamer-Irrigator-Aspirator
femoral reaming
fat embolism
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Synthes Inc.
First posted: 2008-12-31
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of intraoperative embolic events detected with transesophageal echocardiography and transcranial Doppler and the grade or size of these embolic events
timeFrame: During surgery
Secondary outcomes:
measure: Activation of thrombogenesis and VTE complications, intraoperative and postoperative hypoxemia, and level of systemic inflammation.
timeFrame: Post-surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center, University Hospital East
state: Ohio
Study officials:
affiliation: Ohio State University
name: Cornel Van Gorp, M.D.
role: PRINCIPAL_INVESTIGATOR
References: