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

Total Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00815958
• Other study ID #: 2007H0111
• Secondary ID: 60013485
• Status: Terminated
• Phase: N/A
• First received: December 30, 2008
• Last updated: January 20, 2017
• Start date: December 2007
• Est. completion date: March 2009

Study information

• Verified date: January 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center, University Hospital East	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Synthes Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Activation of thrombogenesis and VTE complications, intraoperative and postoperative hypoxemia, and level of systemic inflammation.		Post-surgery