PMCF Neo Pedicle Screw and Cage Systems

Active, not recruiting

• Conditions: Degenerative Disc Disease; Spondylolisthesis; Spinal Stenosis; Spinal Tumor; Pseudoarthrosis of Spine; Trauma
• Interventions: Device: NEO Pedicle Screw System™; Device: Neo Cage System™

• Registration Number: NCT03956537
• Lead Sponsor: Neo Medical SA

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

Not available

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-20
• Study Start: 2019-10-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-13
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pedicle screw system alone	NEO Pedicle Screw System™	-
Pedicle screw system with cages	Neo Cage System™	-
Pedicle screw system with cages	NEO Pedicle Screw System™	-

Primary Outcome Measures

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

Trial Locations

Locations (2)

Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch; 🇩🇪 Sande, Germany

Spine Center, University Hospital Valladolid; 🇪🇸 Valladolid, Spain