PMCF Neo Pedicle Screw and Cage Systems

NCT03956537 | Active Not Recruiting

• 1 other identifier: NeoPMCF01
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Pedicle screw system alone

Device: NEO Pedicle Screw System™

Pedicle screw system with cages

Device: NEO Pedicle Screw System™; Device: Neo Cage System™

Interventions

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.

Pedicle screw system alone; Pedicle screw system with cages

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™

Pedicle screw system with cages

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neo Medical SA: lead
• ConfinisCPM: collaborator

Study Sites (2)

Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch

Sande, 26452, Germany

Location

Spine Center, University Hospital Valladolid

Valladolid, 47006, Spain

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis; Spinal Stenosis; Spinal Cord Neoplasms; Wounds and Injuries

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: October 15, 2019
• Primary Completion: January 31, 2025
• Study Completion (Estimated): October 31, 2028
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

DE (1); ES (1)