JOURNAL ONKOLOGIE – STUDIE
PMCF Neo Pedicle Screw and Cage Systems
Rekrutierend
NCT-Nummer:
NCT03956537
Studienbeginn:
Oktober 2019
Letztes Update:
03.03.2021
Wirkstoff:
-
Indikation (Clinical Trials):
Spinal Stenosis, Intervertebral Disc Degeneration, Spondylolisthesis, Pseudarthrosis
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Neo Medical SA
Collaborator:
ConfinisCPM
Studienleiter
Principal Investigator
Spine Center, University Hospital Valladolid, Valladolid, Spain
Principal Investigator
Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch, Sande, Germany
Kontakt
Kontakt:
Phone: +46 725 45 35 29
E-Mail: ingrid.moberg@neo-medical.com» Kontaktdaten anzeigen
Studienlocations
(2 von 2)
26452 Sande
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Yasser Abdalla, MD
Phone: +49 162 2018181
E-Mail: y.abdalla@sanderbusch.de» Ansprechpartner anzeigen
47006 Valladolid
SpainRekrutierend» Google-Maps
Ansprechpartner:
David C Noriega, PhD, MD
Phone: +34 630 381 468
E-Mail: noriega1970@icloud.com» Ansprechpartner anzeigen
Studien-Informationen
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.
Ein-/Ausschlusskriterien
Inclusion criteria:- 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
Exclusion criteria:
- Patient is under the age of 18 or skeletally immature
- 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
Studien-Rationale
Primary outcome:1. Change in patient´s function from baseline to 12 months (Time Frame - 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.
2. The rate of cage migration in cage-plus-screw systems. (Time Frame - 12 months and 24 months post operatively):
Defined as posterior movement of the cage past the posterior wall of the vertebral body.
3. The rate of pedicle screw loosening in screw only and cage-plus-screw systems. (Time Frame - 12 months and 24 months post operatively):
A radiolucent zone, >1mm, surrounding the pedicle screw seen in radiograhs
Studien-Arme
- Pedicle screw system alone
- Pedicle screw system with cages
Geprüfte Regime
- 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™
Quelle: ClinicalTrials.gov
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