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Active, Not Recruiting

NCT Number: NCT03956537

PMCF Neo Pedicle Screw and Cage Systems

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Degenerative Disc Disease Bone Diseases Central Nervous System Diseases Central Nervous System Neoplasms Intervertebral Disc Degeneration Musculoskeletal Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pseudoarthrosis of Spine Spinal Cord Diseases Spinal Cord Neoplasms Spinal Diseases Spinal Stenosis Spinal Tumor Spondylolisthesis Spondylolysis Spondylosis Trauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch, Sande, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NEO Pedicle Screw System™

Device

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™

Device

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™

Primary outcomes

  1. Change in patient´s function from baseline to 12 months

    Time frame: 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.

  2. The rate of cage migration in cage-plus-screw systems.

    Time frame: 12 months and 24 months post operatively

    Defined as posterior movement of the cage past the posterior wall of the vertebral body.

  3. The rate of pedicle screw loosening in screw only and cage-plus-screw systems.

    Time frame: 12 months and 24 months post operatively

    A radiolucent zone, >1mm, surrounding the pedicle screw seen in radiograhs

Sponsors and collaborators

Lead sponsor

Neo Medical SA

Industry

Collaborators

  • ConfinisCPM

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2028
First posted
May 20, 2019
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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