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PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
Sponsor: Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
561
Start Date
2026-04-27
Completion Date
2028-09-26
Last Updated
2026-05-29
Healthy Volunteers
No
Conditions
Interventions
Titania® Cervical Interbody Fusion Cage (Titanium)
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Interbody Fusion Cage (PEEK)
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Posterior Cervical Stabilization System
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Plate System
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Dynamic Stabilization System (Elastic Rod)
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Disc Prosthesis (Titanium)
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Cervical Disc Prosthesis (PEEK)
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Lumbar Interbody Fusion Cages (Titanium)
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Lumbar Interbody Fusion Cages (PEEK)
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Interspinous Fusion Device (Titanium)
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Posterior Thoracolumbar Stabilization Systems
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Posterior Thoracolumbar Clamp Systems
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Titania® Thoracolumbar Dynamic Stabilization System (Elastic Rod)
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Bonegraft® Synthetic Bone Grafts
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Bonegraft® Bone Cement
This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
Locations (3)
Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Neurosurgery
Izmir, Turkey (Türkiye)
Demokrasi University Buca Seyfi Demirsoy Training and Research Hospital, Department of Neurosurgery
Izmir, Turkey (Türkiye)
Van Yuzuncu Yil University Dursun Odabas Medical Center, Department of Neurosurgery
Van, Turkey (Türkiye)