Clinical trial · Observational
PMCF Neo Pedicle Screw and Cage Systems
Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study
NCT03956537CI-TRIAL-00090984active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Degenerative Disc Disease | — | UNRESOLVED | — |
| Pseudoarthrosis of Spine | — | UNRESOLVED | — |
| Spinal Stenosis | — | UNRESOLVED | — |
| Spinal Tumor | — | UNRESOLVED | — |
| Spondylolisthesis | — | UNRESOLVED | — |
| Trauma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neo Cage System™ | Device | — | UNRESOLVED |
| NEO Pedicle Screw System™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Pedicle screw system alone
- interventionNames
- Device: NEO Pedicle Screw System™
- label
- Pedicle screw system with cages
- interventionNames
- Device: NEO Pedicle Screw System™
- Device: Neo Cage System™
Primary outcomes (3)
- measure
- Change in patient´s function from baseline to 12 months
- timeFrame
- 12 months
- description
- 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.
- measure
- The rate of cage migration in cage-plus-screw systems.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.