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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Neck Disability Index (NDI) score from baseline (for Cervical Spinal Instrumentation and Fusion Systems)
Timeframe: [12 months]
2
Change in Oswestry Disability Index (ODI) score from baseline (for Thoracolumbar Spinal Instrumentation and Fusion Systems)
Timeframe: [12 months]
3
Fusion rate for Spinal Fusion Systems
Timeframe: [12 months]
4
Adjacent segment motion in subjects with dynamic instrumentation
Timeframe: [12 months]
5
Change in Intervertebral Disc Height
Timeframe: [12 months]
6
Assessment of Intervertebral Disc Degeneration
Timeframe: 12 months
7
Cervical and segmental lordosis assessment (for Cervical Spinal Instrumentation and Fusion Systems)
Timeframe: [12 months]
Trial details
NCT IDNCT07615491
SponsorMetrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.