Status:
UNKNOWN
Cost Effectiveness and Clinical Utility of Cell Saver Use for Two to Three Level Lumbar Fusions
Lead Sponsor:
Norton Leatherman Spine Center
Conditions:
Low Back Pain Unresponsive to Non-surgical Care
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the cost-effectiveness of using a cell saver for 2 to 3 level lumbar fusions. A secondary objective is to determine if there will be a decrease in the number ...
Detailed Description
INTRODUCTION: Cell Savers are used intraoperatively to decrease the risk of transfusion due to surgical blood loss. Blood collected from the operative field is anticoagulated, filtered, and stored in...
Eligibility Criteria
Inclusion
- At least 18 years of age at time of enrollment
- Signed informed consent
- Requires fusion of 2 to 3 levels from L1-S1 for degenerative lumbar disorders
Exclusion
- Spinal trauma/fracture/malignancy
- Infection as an indication for surgery
- Pregnant or nursing women
- Prisoners
- Institutionalized in a non-voluntary and/or dependent residence (including hospitals, group homes, etc.), who may not be competent to give informed consent.
- Inability to speak or understand English
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2013
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01453309
Start Date
October 1 2011
End Date
October 1 2013
Last Update
October 17 2011
Active Locations (1)
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1
Norton Leatherman Spine Center
Louisville, Kentucky, United States, 40202