Embolic Events Detected During Total Knee Arthroplasty With the Use of RIA (Reamer-Irrigator-Aspirator)
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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 |
- 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 ]
- 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:
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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:
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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 |
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| United States, Ohio | |
| The Ohio State University Medical Center, University Hospital East | |
| Columbus, Ohio, United States, 43205 | |
| 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 May 16, 2013