NCT07615491 PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
| NCT ID | NCT07615491 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co. |
| Condition | Degenerative Disc Disease (DDD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 561 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2028-04-26 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 561 participants in total. It began in 2026-04-27 with a primary completion date of 2028-04-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.)
Contact & Investigator
Hasan Kamil Sucu, Professor
STUDY DIRECTOR
Izmir Katip Celebi University Ataturk Training and Research Hospital
Frequently Asked Questions
Who can join the NCT07615491 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Degenerative Disc Disease (DDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07615491 currently recruiting?
Yes, NCT07615491 is actively recruiting participants. Contact the research team at b.tulu@metrosan.com.tr for enrollment information.
Where is the NCT07615491 trial being conducted?
This trial is being conducted at Izmir, Turkey (Türkiye), Izmir, Turkey (Türkiye), Van, Turkey (Türkiye).
Who is sponsoring the NCT07615491 clinical trial?
NCT07615491 is sponsored by Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.. The principal investigator is Hasan Kamil Sucu, Professor at Izmir Katip Celebi University Ataturk Training and Research Hospital. The trial plans to enroll 561 participants.