The purpose of this chart review is to assess outcomes in subjects that received MAGNIFUSE in the posterolateral lumbar spine at 1 or 2 continuous levels from L1-S1.
Study Type
OBSERVATIONAL
Enrollment
76
Midwest Ortho. Center
Peoria, Illinois, United States
University of Virginia
Charlottesville, Virginia, United States
Fusion status at 12 or 24 months
Fusion status will be assessed using the Lenke posterior fusion criteria below: * Grade I: Solid trabeculated transverse process and facet fusions bilaterally. * Grade II: Thick fusion mass on one side, and difficult to visualize on the other side. * Grade III: Suspected lucency or defect in the fusion mass. * Grade IV: Definite resorption of graft with fatigue of instrumentation.
Time frame: 12 or 24 months
Back pain and leg pain measured by visual analog scale (VAS)
Time frame: 12 or 24 months
Pain and Disability status measured by Oswestry Disability Index (ODI)
Time frame: 12 or 24 months
Quality of life measured by EQ-5D
Time frame: 12 or 24 months
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