Spots Global Cancer Trial Database for PMCF Neo Pedicle Screw and Cage Systems
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Trial Identification
Brief Title: PMCF Neo Pedicle Screw and Cage Systems
Official Title: Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study
Study ID: NCT03956537
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch, Sande, , Germany
Spine Center, University Hospital Valladolid, Valladolid, , Spain
Contact Details
Name: David C Noriega, PhD, MD
Affiliation: Spine Center, University Hospital Valladolid, Valladolid, Spain
Role: PRINCIPAL_INVESTIGATOR
Name: Yasser Abdalla, MD
Affiliation: Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch, Sande, Germany
Role: PRINCIPAL_INVESTIGATOR
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