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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

December 30, 2008
September 11, 2009
December 2007
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00815958 on ClinicalTrials.gov Archive Site
Activation of thrombogenesis and VTE complications, intraoperative and postoperative hypoxemia, and level of systemic inflammation. [ Time Frame: Post-surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • Total Knee Replacement
  • TKA
  • 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
  • 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
  • Experimental: A
    Reaming with Synthes RIA (Reamer-Irrigator-Aspirator)
    Intervention: Procedure: Reaming with Synthes RIA (Reamer-Irrigator-Aspirator)
  • Active Comparator: B
    Reaming with conventional reamer
    Intervention: Procedure: Reaming with conventional reamer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00815958
2007H0111, 60013485
No
Cornel Van Gorp, MD, The Ohio State University Medical Center
Ohio State University
Synthes Inc.
Principal Investigator: Cornel Van Gorp, M.D. Ohio State University
Ohio State University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP