Clinical Evaluation of TruFUSE_ Lumbar Facet Fusion System.docVIP

Clinical Evaluation of TruFUSE_ Lumbar Facet Fusion System.doc

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Clinical Evaluation of TruFUSE_ Lumbar Facet Fusion System

Surgical Science, 2013, 4, 166-175 /10.4236/ss.2013.42032 Published Online February 2013 (/journal/ss) ? Clinical Evaluation of TruFUSE Lumbar Facet Fusion System Joseph C. Maroon, Jeff W. Bost , Darren B. LePere, Stephanie M. Bost, * Louis Williams, Austin S. Amos Department of Neurosurgery, University of Pittsburgh Medical Center, Pittsburgh, USA Email: maroonjc@, * bostj@ Received December 12, 2012; revised January 14, 2013; accepted January 23, 2013 ABSTRACT Introduction: The TruFUSE joints. We evaluated subjects undergoing TruFUSE operative time, length of stay, blood loss and outcome to a similar literature-based cohort of patients undergoing pedicle screw fusion (PSF). Methods: From 2009 to 2011, 41 subjects (17 M, 24 F, aver. age 69.5 yr) underwent TruFUSE ? lumbar facet fusion system is a unique allograft milled bone dowel used to fuse facet fusion for stable grade I spondylolisthesis and stenosis comparing ? ? facet fusion along with transverse process bone fusion and laminectomy. Length of stay, operative time, blood loss and outcomes were compared to eight literature-based cohort that analyzed similar parameters following pedicle screw fu- sion. Results: The 41 subjects’ mean operative time for laminectomy, transverse process fusion and TruFUSE fusion was 106 min, with a mean blood loss of 145 cm , and a mean hospital stay of 1.7 days (77% one day). A fol- ? facet 3 low-up at average six months, 33 (80%) subjects reported subjective outcomes of “excellent” or “somewhat improved”, four (10%) “unchanged” and four (10%) “worse”. Flexion and extension radiographs showed 39 of the 41 patients (95%) had spinal stability at an average six months post-op and all (100%) had signs of early fusion. Discussion: TruFUSE ? subjects had significantly (p 0.0001) shorter surgeries (106 min compared to the literature data range of 185 - 240 min); significantly (p 0.0001) shorter hospitalization (1.7

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