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

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

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.)

Conditions9

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