Status:
TERMINATED
Embolic Events Detected During Total Knee Arthroplasty With the Use of RIA (Reamer-Irrigator-Aspirator)
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Synthes Inc.
Conditions:
Total Knee Replacement
Eligibility:
All Genders
18+ years
Phase:
NA
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, cardiopu...
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00815958
Start Date
December 1 2007
End Date
March 1 2009
Last Update
January 24 2017
Active Locations (1)
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1
The Ohio State University Medical Center, University Hospital East
Columbus, Ohio, United States, 43205