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

Embolic Events Detected During Total Knee Arthroplasty With and Without the Use of RIA (Reamer-Irrigator-Aspirator): A Blinded, Randomized, Controlled Clinical Study

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 Overview

• Status: Terminated
• Conditions: Total Knee Replacement
• Intervention / Treatment: Procedure: Reaming with Synthes RIA (Reamer-Irrigator-Aspirator); Procedure: Reaming with conventional reamer

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • The Ohio State University Medical Center, University Hospital East

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Reaming with Synthes RIA (Reamer-Irrigator-Aspirator)	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.; Other Names: Synthes Reamer-Irrigator-Aspirator; RIA
Active Comparator: B; Reaming with conventional reamer	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.; Other Names: Synthes Reamer-Irrigator-Aspirator; RIA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of intraoperative embolic events detected with transesophageal echocardiography and transcranial Doppler and the grade or size of these embolic events	During surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Activation of thrombogenesis and VTE complications, intraoperative and postoperative hypoxemia, and level of systemic inflammation.	Post-surgery

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Synthes Inc.
• Investigators: Principal Investigator: Cornel Van Gorp, M.D., Ohio State University

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: December 30, 2008
• First Submitted That Met QC Criteria: December 30, 2008
• First Posted (Estimate): December 31, 2008

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: knee replacement surgery; Reamer-Irrigator-Aspirator; femoral reaming; fat embolism
• Other Study ID Numbers: 2007H0111; 60013485