The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.
Study Type
OBSERVATIONAL
Enrollment
150
The NEO Pedicle Screw System™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
Neo Cage System™ is intended to be used with bone graft material to facilitate interbody fusion and to be used with the NEO Pedicle Screw System™
Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch
Sande, Germany
Spine Center, University Hospital Valladolid
Valladolid, Spain
Change in patient´s function from baseline to 12 months
Clinical outcome in function as measured by the 100 point Oswestry Disability Index (ODI). Zero is equated with no disability and 100 is the maximum disability possible.
Time frame: 12 months
The rate of cage migration in cage-plus-screw systems.
Defined as posterior movement of the cage past the posterior wall of the vertebral body.
Time frame: 12 months and 24 months post operatively
The rate of pedicle screw loosening in screw only and cage-plus-screw systems.
A radiolucent zone, \>1mm, surrounding the pedicle screw seen in radiograhs
Time frame: 12 months and 24 months post operatively
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