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
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Turkey
Demokrasi University Buca Seyfi Demirsoy Training and Research Hospital, Department of Neurosurgery
NOT_YET_RECRUITING
Izmir
Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Neurosurgery
RECRUITING
Izmir
Van Yuzuncu Yil University Dursun Odabas Medical Center, Department of Neurosurgery
NOT_YET_RECRUITING
Van
Contact Information
Primary
Burak Tülü, Sponsor's Representative
b.tulu@metrosan.com.tr
+90 (236) 213 10 14
Time Frame
Start Date:2026-04-27
Estimated Completion Date:2028-09-26
Participants
Target number of participants:561
Treatments
Cervical Interbody Fusion Cages (Titanium)
Subjects undergoing surgery with Titania® Cervical Interbody Fusion Cages (Titanium) will be followed for 12 months.
Cervical Interbody Fusion Cages (PEEK)
Subjects undergoing surgery with Titania® Cervical Interbody Fusion Cages (PEEK) will be followed for 12 months.
Posterior Cervical Stabilization Systems
Subjects undergoing surgery with Titania® Posterior Cervical Stabilization Systems will be followed for 12 months.
Cervical Plate Systems
Subjects undergoing surgery with Titania® Cervical Plate System will be followed for 12 months.
Cervical Dynamic Stabilization Systems (Elastic Rod)
Subjects undergoing surgery with Titania® Cervical Dynamic Stabilization Systems (Elastic Rod) will be followed for 12 months.
Cervical Disc Prosthesis (Titanium)
Subjects undergoing surgery with Titania® Cervical Disc Prosthesis (Titanium) will be followed for 12 months.
Cervical Disc Prosthesis (PEEK)
Subjects undergoing surgery with Titania® Cervical Disc Prosthesis (PEEK) will be followed for 12 months.
Lumbar Interbody Fusion Cages (Titanium)
Subjects undergoing surgery with Titania® Lumbar Interbody Fusion Cages (Titanium) will be followed for 12 months.
Lumbar Interbody Fusion Cages (PEEK)
Subjects undergoing surgery with Titania® Lumbar Interbody Fusion Cages (PEEK) will be followed for 12 months.
Interspinous Fusion Device (Titanium)
Subjects undergoing surgery with Titania® Interspinous Fusion Device (Titanium) will be followed for 12 months.
Posterior Thoracolumbar Stabilization Systems
Subjects undergoing surgery with Titania® Posterior Thoracolumbar Stabilization Systems will be followed for 12 months.
Posterior Thoracolumbar Clamp Systems
Subjects undergoing surgery with Titania® Posterior Thoracolumbar Clamp Systems will be followed for 12 months.
Thoracolumbar Dynamic Stabilization Systems (Elastic Rod)
Subjects undergoing surgery with Titania® Thoracolumbar Dynamic Stabilization Systems (Elastic Rod) will be followed for 12 months.
Synthetic Bone Grafts (Cervical Application)
Subjects undergoing surgery with Bonegraft® Synthetic Bone Grafts will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., NDI scores) in the cervical region.
Synthetic Bone Grafts (Thoracolumbar Application)
Subjects undergoing surgery with Bonegraft® Synthetic Bone Grafts will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the thoracolumbar region.
Bone Cement (Cervical Application)
Subjects undergoing surgery with Bonegraft® Synthetic Bone Cement will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the cervical region.
Bone Cement (Thoracolumbar Application)
Subjects undergoing surgery with Bonegraft® Synthetic Bone Cement will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the thoracolumbar region.