Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study
Status: Active_not_recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patient has undergone or is intended to undergo surgery with the Neo Pedicle Screw System™, standalone or in combination with the Neo Cage System™, for any of the approved indications as defined in the respective labelling
• Patient has participated in or is willing to participate in the routine postoperative follow-up program
• Patient is willing to provide written informed consent
Locations
Other Locations
Germany
Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch
Sande
Spain
Spine Center, University Hospital Valladolid
Valladolid
Time Frame
Start Date: 2019-10-15
Completion Date: 2028-10-31
Participants
Target number of participants: 150
Treatments
Pedicle screw system alone
Pedicle screw system with cages
Related Therapeutic Areas
Sponsors
Collaborators: ConfinisCPM
Leads: Neo Medical SA