Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Columbus, Ohio 43205


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00815958


Primary Contact:

Principal Investigator
Cornel Van Gorp, M.D.
Ohio State University


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43205
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.