PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials

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.

Conditions

• Degenerative Disc Disease (DDD)
• Spinal Stenosis
• Spondylolisthesis
• Spinal Deformities
• Spinal Tumors
• Spinal Infections
• Spinal Trauma
• Vertebral Fractures

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Bonegraft Biyolojik Malzemeler San. ve Tic. A.S.

  collaborator INDUSTRY

• Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.

  lead INDUSTRY

Principal Investigators

• Hasan Kamil Sucu, Professor · Izmir Katip Celebi University Ataturk Training and Research Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-27

Primary Completion

2028-04-26

Completion

2028-09-26

Countries

• Turkey (Türkiye)

Study Locations