PMCF look at METROSAN spinal systems and BONEGRAFT materials in adults after spine surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center, observational PMCF study collecting real-world safety and performance data on CE-marked METROSAN Titania spinal instrumentation and BONEGRAFT bone filling materials. Data come from routine preoperative, intraoperative, and follow-up visits over 12 months, including retrospective files review and prospective e-CRF follow-up. Patients are evaluated at Day 12, Week 6, and Months 3, 6, and 12 to identify complications and overall effectiveness. Seventeen product groups, covering cervical and thoracolumbar implants and stabilization devices, are assessed independently in real-world practice.

Why it matters

Who can join: the full rules

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.)

Where it's running

• Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Neurosurgery
  Izmir, Turkey (Türkiye) Recruiting
• Demokrasi University Buca Seyfi Demirsoy Training and Research Hospital, Department of Neurosurgery
  Izmir, Turkey (Türkiye) Not yet recruiting
• Van Yuzuncu Yil University Dursun Odabas Medical Center, Department of Neurosurgery
  Van, Turkey (Türkiye) Not yet recruiting

Study contacts

• Study coordinator: Burak Tülü, Sponsor's Representative
• Email: b.tulu@metrosan.com.tr
• Phone: +90 (236) 213 10 14

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.