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

Recruiting now

Conditions studied: Degenerative Disc Disease (DDD), Spinal Stenosis, Spondylolisthesis, Spinal Deformities, Spinal Tumors, Spinal Infections, Spinal Trauma, Vertebral Fractures

In brief

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.

Key facts

Study ID

NCT07615491

Run by

Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.

People needed

561

Starts

2026-04-27

Expected to finish

2028-09-26

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

• Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Neurosurgery — Izmir, Turkey (Türkiye) (enrolling)
• 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)

Full record on ClinicalTrials.gov

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