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

NCT ID: NCT00815958

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-03-31

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.

Conditions

Total Knee Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

A

Reaming with Synthes RIA (Reamer-Irrigator-Aspirator)

Group Type: EXPERIMENTAL

Reaming with Synthes RIA (Reamer-Irrigator-Aspirator)

Intervention Type: PROCEDURE

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.

B

Reaming with conventional reamer

Group Type: ACTIVE_COMPARATOR

Reaming with conventional reamer

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Synthes Reamer-Irrigator-Aspirator; RIA; Synthes Reamer-Irrigator-Aspirator; RIA

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synthes Inc.

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cornel Van Gorp, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Medical Center, University Hospital East

Columbus, Ohio, United States

Countries

United States

Other Identifiers

60013485

Identifier Type: -

Identifier Source: secondary_id

2007H0111

Identifier Type: -

Identifier Source: org_study_id