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

This study has been terminated.
(administrative reasons)
Sponsor:
Collaborator:
Synthes Inc.
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00815958
First received: December 30, 2008
Last updated: September 11, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Total Knee Replacement
TKA
Procedure: Reaming with Synthes RIA (Reamer-Irrigator-Aspirator)
Procedure: Reaming with conventional reamer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • The incidence of intraoperative embolic events detected with transesophageal echocardiography and transcranial Doppler and the grade or size of these embolic events [ Time Frame: During surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Activation of thrombogenesis and VTE complications, intraoperative and postoperative hypoxemia, and level of systemic inflammation. [ Time Frame: Post-surgery ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: December 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815958

Locations
United States, Ohio
The Ohio State University Medical Center, University Hospital East
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Ohio State University
Synthes Inc.
Investigators
Principal Investigator: Cornel Van Gorp, M.D. Ohio State University
  More Information

No publications provided

Responsible Party: Cornel Van Gorp, MD, The Ohio State University Medical Center
ClinicalTrials.gov Identifier: NCT00815958     History of Changes
Other Study ID Numbers: 2007H0111, 60013485
Study First Received: December 30, 2008
Last Updated: September 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
knee replacement surgery
TKA
Reamer-Irrigator-Aspirator
femoral reaming
fat embolism

ClinicalTrials.gov processed this record on October 02, 2014