AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

Recruitingn/aAges 18 Years - anyAllMetrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz…
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.)
💊

What it tests

  • Titania® Cervical Interbody Fusion Cage (Titanium)
  • Titania® Cervical Interbody Fusion Cage (PEEK)
  • Titania® Posterior Cervical Stabilization System
  • Titania® Cervical Plate System
  • Titania® Cervical Dynamic Stabilization System (Elastic Rod)
📍

Where

3 sites
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)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy