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NCT03956537 Clinical Trial

PMCF Neo Pedicle Screw and Cage Systems

Trauma Clinical Trial

Official title:
Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03956537
Other study ID # NeoPMCF01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 15, 2019
Est. completion date September 2024

Study information
Verified date February 2023
Source Neo Medical SA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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
Country Name City State
Germany Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch Sande
Spain Spine Center, University Hospital Valladolid Valladolid

Sponsors (2)
Lead Sponsor Collaborator
Neo Medical SA ConfinisCPM

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in patient´s function from baseline to 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. 12 months
Primary The rate of cage migration in cage-plus-screw systems. Defined as posterior movement of the cage past the posterior wall of the vertebral body. 12 months and 24 months post operatively
Primary The rate of pedicle screw loosening in screw only and cage-plus-screw systems. A radiolucent zone, >1mm, surrounding the pedicle screw seen in radiograhs 12 months and 24 months post operatively
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