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NCT00815958 · ClinicalTrials.gov registry record · NA
Embolic Events Detected During Total Knee Arthroplasty With the Use of RIA (Reamer-Irrigator-Aspirator)
A NA study, sponsored by Ohio State University.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT00815958 is a NA study that was terminated before completion, run by Ohio State University. The registered enrollment target is 6 participants.
The verdict
NCT00815958, a NA study, was terminated before completion, sponsored by Ohio State University.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Reaming with Synthes RIA (Reamer-Irrigator-Aspirator)
- PROCEDURE Reaming with conventional reamer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00815958
The ClinicalTrials.gov registry entry for NCT00815958 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Reaming with Synthes RIA (Reamer-Irrigator-Aspirator) is the first listed.
NCT00815958 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00815958 about?
NCT00815958 is a clinical study titled "Embolic Events Detected During Total Knee Arthroplasty With the Use of RIA (Reamer-Irrigator-Aspirator)". 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...
What is the current status of trial NCT00815958?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2007-12. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00815958?
The interventions under investigation include: Reaming with Synthes RIA (Reamer-Irrigator-Aspirator) (PROCEDURE), Reaming with conventional reamer (PROCEDURE).
Who is sponsoring clinical trial NCT00815958?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
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