Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT00815958
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.
Study:
NCT00815958
Study Brief:
Protocol Section:
NCT00815958