Embolic Events Detected During Total Knee Arthroplasty With the Use of RIA (Reamer-Irrigator-Aspirator)
Stopped early · Not applicable
Conditions studied: Total Knee Replacement
In brief
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.
Key facts
- Study ID
- NCT00815958
- Run by
- Ohio State University
- People needed
- 6
- Starts
- 2007-12-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2017-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Ohio State University Medical Center, University Hospital East — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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