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PMCF Neo Pedicle Screw and Cage Systems

NCT03956537 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-06-13

No results posted yet for this study

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.

Conditions

  • Degenerative Disc Disease
  • Spondylolisthesis
  • Spinal Stenosis
  • Spinal Tumor
  • Trauma
  • Pseudoarthrosis of Spine

Interventions

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™

Sponsors & Collaborators

  • ConfinisCPM

    collaborator UNKNOWN

  • Neo Medical SA

    lead INDUSTRY

Principal Investigators

  • David C Noriega, PhD, MD · Spine Center, University Hospital Valladolid, Valladolid, Spain

  • Yasser Abdalla, MD · Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch, Sande, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2025-01-31
Completion
2028-10-31

Countries

  • Germany
  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03956537 on ClinicalTrials.gov