NCT03956537

PMCF Neo Pedicle Screw and Cage Systems

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Neo Medical SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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™

Timeline

• Start date: 2019-10-15
• Primary completion: 2025-01-31
• Completion: 2028-10-31
• First posted: 2019-05-20
• Last updated: 2025-06-13

Locations

2 sites across 2 countries: Germany, Spain