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PMCF Neo Pedicle Screw and Cage Systems
Sponsor: Neo Medical SA
Summary
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.
Official title: Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2019-10-15
Completion Date
2028-10-31
Last Updated
2025-06-13
Healthy Volunteers
No
Conditions
Interventions
NEO Pedicle Screw System™
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™
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™
Locations (2)
Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch
Sande, Germany
Spine Center, University Hospital Valladolid
Valladolid, Spain