Clinical trial · Observational
PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
A Prospective, Multi-Center, Observational Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials Used in Spinal Instrumentation and Fusion Surgery
- 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)
This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems, and Bonegraft® bone filling materials (synthetic bone grafts and bone cements). The study aims to evaluate short-term (12-month) safety and effectiveness, identify previously unknown side effects, monitor defined complications, and assess risks based on real-world evidence in patients undergoing spinal surgery. All investigated products are used within their intended purpose under routine clinical practice.
Conditions
Conditions (8)
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 (DDD) | — | UNRESOLVED | — |
| Spinal Deformities | — | UNRESOLVED | — |
| Spinal Infections | — | UNRESOLVED | — |
| Spinal Stenosis | — | UNRESOLVED | — |
| Spinal Trauma | — | UNRESOLVED | — |
| Spinal Tumors | — | UNRESOLVED | — |
| Spondylolisthesis | — | UNRESOLVED | — |
| Vertebral Fractures | — | UNRESOLVED | — |
Interventions
Interventions (15)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bonegraft® Bone Cement | Device | — | UNRESOLVED |
| Bonegraft® Synthetic Bone Grafts | Device | — | UNRESOLVED |
| Titania® Cervical Disc Prosthesis (PEEK) | Device | — | UNRESOLVED |
| Titania® Cervical Disc Prosthesis (Titanium) | Device | — | UNRESOLVED |
| Titania® Cervical Dynamic Stabilization System (Elastic Rod) | Device | — | UNRESOLVED |
| Titania® Cervical Interbody Fusion Cage (PEEK) | Device | — | UNRESOLVED |
| Titania® Cervical Interbody Fusion Cage (Titanium) | Device | — | UNRESOLVED |
| Titania® Cervical Plate System | Device |
Design
Arms and outcomes
Arms (17)
- label
- Cervical Interbody Fusion Cages (Titanium)
- description
- Subjects undergoing surgery with "Titania® Cervical Interbody Fusion Cages (Titanium)" will be followed for 12 months.
- interventionNames
- Device: Titania® Cervical Interbody Fusion Cage (Titanium)
- label
- Cervical Interbody Fusion Cages (PEEK)
- description
- Subjects undergoing surgery with "Titania® Cervical Interbody Fusion Cages (PEEK)" will be followed for 12 months.
- interventionNames
- Device: Titania® Cervical Interbody Fusion Cage (PEEK)
- label
- Posterior Cervical Stabilization Systems
- description
- Subjects undergoing surgery with "Titania® Posterior Cervical Stabilization Systems" will be followed for 12 months.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older. * Skeletally mature. * Male or female. * Undergone spinal surgery (cervical or thoracolumbar) for any indication under current medical practice. * Titania® spinal stabilization/fusion systems and/or BONEGRAFT® bone cements or BONEGRAFT® bone graft materials used during the operation. * No general health condition contraindicating surgery. * No legal restriction (military service, incarceration, or equivalent). * Provision of signed and dated Informed Consent Form (ICF) Exclusion Criteria: * Participation in another interventional clinical investigation * Suspected or confirmed pregnancy * Morbid obesity * Neurological or psychiatric conditions preventing compliance with postoperative care and instructions * Active spinal or systemic infection * High fever or leukocytosis * Severe osteoporosis and/or disease affecting bone metabolism * Known allergy or hypersensitivity to PEEK, Titanium, or PMMA * Congenital abnormality, tumor, or other condition preventing secure implant fixation or likely to shorten implant useful life * Inadequate tissue coverage at the operative site * Legally restricted individuals (military personnel, prisoners, etc.)
References
Publications (0)
Data not yet available