Cost Effectiveness and Clinical Utility of Cell Saver Use for Two to Three Level Lumbar Fusions

Status unconfirmed · Not applicable

Conditions studied: Low Back Pain Unresponsive to Non-surgical Care

In brief

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 of allogenic blood transfusions when a cell saver is used intraoperatively. Another secondary objective is to determine incidence of complications associated with cell saver use and transfusions.

Key facts

Study ID

NCT01453309

Run by

Norton Leatherman Spine Center

People needed

240

Starts

2011-10-01

Expected to finish

2013-10-01

Last updated by the study team

2011-10-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Norton Leatherman Spine Center — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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