PMCF Neo Pedicle Screw and Cage Systems

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Trauma; Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis; Spinal Tumor; Pseudoarthrosis of Spine
• Intervention / Treatment: Device: NEO Pedicle Screw System™; Device: Neo Cage System™

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: ingrid Moberg, DDS; Phone Number: +46 725 45 35 29; Email: ingrid.moberg@neo-medical.com

Study Locations

• Germany
  • Sande, Germany, 26452
    • Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch
• Spain
  • Valladolid, Spain, 47006
    • Spine Center, University Hospital Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In total, approximately 150 patients will be recruited and enrolled to ensure that at least 132 patients are evaluable at 12 and 24 months. Patients are recruited consecutively, retrospectively as well as prospectively. The potential patients to be recruited have either already been implanted or are planned to be implanted with the Neo Pedicle Screw System (Arm 1) or Neo Cage System and Neo Pedicle Screw System (Arm 2).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pedicle screw system alone	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.
Pedicle screw system with cages	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.; Device: 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™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Neo Medical SA
• Collaborators: ConfinisCPM
• Investigators: Principal Investigator: David C Noriega, PhD, MD, Spine Center, University Hospital Valladolid, Valladolid, Spain; Principal Investigator: Yasser Abdalla, MD, Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch, Sande, Germany

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2019
• Primary Completion (ANTICIPATED): September 1, 2024
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (ACTUAL): May 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Spinal Diseases; Bone Diseases; Bone Neoplasms; Spondylolysis; Spondylosis; Fractures, Ununited; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis; Spinal Cord Neoplasms; Spinal Neoplasms; Pseudarthrosis
• Other Study ID Numbers: NeoPMCF01