Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
150 participants
OBSERVATIONAL
2019-10-15
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Pedicle screw system alone
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.
Pedicle screw system with cages
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™
Interventions
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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™
Eligibility Criteria
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Inclusion Criteria
* Patient has participated in or is willing to participate in the routine postoperative follow-up program
* Patient is willing to provide written informed consent
Exclusion Criteria
* Patient had or has a contraindication to surgery or to any of the implant systems used in the study, as defined in the respective labelling
18 Years
ALL
No
Sponsors
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ConfinisCPM
UNKNOWN
Neo Medical SA
INDUSTRY
Responsible Party
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Principal Investigators
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David C Noriega, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Spine Center, University Hospital Valladolid, Valladolid, Spain
Yasser Abdalla, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch, Sande, Germany
Locations
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Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch
Sande, , Germany
Spine Center, University Hospital Valladolid
Valladolid, , Spain
Countries
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Other Identifiers
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NeoPMCF01
Identifier Type: -
Identifier Source: org_study_id
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