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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Pseudarthrosis
• Pseudoarthrosis of Spine
• Spinal Cord Neoplasms
• Spinal Neoplasms
• Spinal Stenosis
• Spinal Tumor
• Spondylolisthesis
• Trauma

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