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Embolic Events Detected During Total Knee Arthroplasty With the Use of RIA (Reamer-Irrigator-Aspirator)

NCT00815958 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-01-24

No results posted yet for this 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.

Conditions

  • Total Knee Replacement

Interventions

PROCEDURE

Reaming with Synthes RIA (Reamer-Irrigator-Aspirator)

During knee replacement surgery, the study anesthesiologist will place probes for the transesophageal echocardiogram (TEE) and the transcranial Doppler ultrasound (TCD). In patients randomized to the RIA group (Arm A), surgery performed by the investigating orthopaedic surgeon will be done according to standard of care guidelines up until femoral reaming. These patients will receive reaming with RIA. The remainder of the surgery will also be done according to the standard of care. TEE and TCD data will be recorded throughout the surgery.

PROCEDURE

Reaming with conventional reamer

During knee replacement surgery, the study anesthesiologist will place probes for the transesophageal echocardiogram (TEE) and the transcranial Doppler ultrasound (TCD). In patients randomized to the control group (Arm B), surgery performed by the investigating orthopaedic surgeon will be done according to standard of care guidelines. These patients will receive reaming with the conventional method/reamer. TEE and TCD data will be recorded throughout the surgery.

Sponsors & Collaborators

  • Synthes Inc.

    collaborator INDUSTRY

  • Ohio State University

    lead OTHER

Principal Investigators

  • Cornel Van Gorp, M.D. · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00815958 on ClinicalTrials.gov