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

Официальное название

A Prospective, Multi-Center, Observational Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials Used in Spinal Instrumentation and Fusion Surgery

Обзор

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.

Подробное описание

This prospective, multi-center, observational study evaluates the safety and clinical performance of Titania® spinal instrumentation and fusion systems (manufactured by METROSAN End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Sti.) and Bonegraft® bone filling materials, including synthetic bone grafts and bone cements (manufactured by Bonegraft Biyolojik Malzemeler San. ve Tic. A.S.). All investigational products are CE marked and registered in the Turkish Ministry of Health's Product Tracking System (UTS).

The study is purely observational; no additional medical procedures, interventions, or tests beyond routine clinical practice will be performed. Data collection includes retrospective review of preoperative and intraoperative information from patient files, followed by prospective follow-up data collection using a study-specific Electronic Case Report Form (e-CRF). Subjects will be evaluated during routine clinical visits at post-operative Day 12 (±5 days), Week 6, and Months 3, 6, and 12.

Seventeen distinct product groups are evaluated independently, covering cervical interbody fusion cages (Titanium and PEEK), posterior cervical stabilization systems, cervical plate systems, cervical dynamic stabilization systems, cervical disc prostheses (Titanium and PEEK), lumbar interbody fusion cages (Titanium and PEEK), interspinous fusion devices, posterior thoracolumbar stabilization systems, posterior thoracolumbar clamp systems, thoracolumbar dynamic stabilization systems, and bone filling materials (bone cements and synthetic bone grafts).

The enrollment period is planned for 12 months, followed by a 12-month follow-up for each participant. An additional 5 months is allocated for data analysis and reporting, with a total study duration of 29 months. The total estimated enrollment is 561 subjects.

The study is conducted in accordance with the EU Medical Device Regulation (MDR) 2017/745, the Turkish Medical Device Regulation (dated 02.06.2021), ICH-GCP guidelines, the Declaration of Helsinki, and applicable Turkish legislation regarding the protection of personal data.

Вмешательства

• Устройство Titania® Cervical Interbody Fusion Cage (Titanium)
  This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
• Устройство Titania® Cervical Interbody Fusion Cage (PEEK)
  This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
• Устройство Titania® Posterior Cervical Stabilization System
  This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
• Устройство Titania® Cervical Plate System
  This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
• Устройство Titania® Cervical Dynamic Stabilization System (Elastic Rod)
  This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
• Устройство Titania® Cervical Disc Prosthesis (Titanium)
  This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
• Устройство Titania® Cervical Disc Prosthesis (PEEK)
  This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
• Устройство Titania® Lumbar Interbody Fusion Cages (Titanium)
  This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
• Устройство Titania® Lumbar Interbody Fusion Cages (PEEK)
  This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.
• Устройство Titania® Interspinous Fusion Device (Titanium)
  This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.

Первичные конечные точки

• Change in Neck Disability Index (NDI) score from baseline (for Cervical Spinal Instrumentation and Fusion Systems) [Срок оценки: [12 months]]
• Change in Oswestry Disability Index (ODI) score from baseline (for Thoracolumbar Spinal Instrumentation and Fusion Systems) [Срок оценки: [12 months]]
• Fusion rate for Spinal Fusion Systems [Срок оценки: [12 months]]
• Adjacent segment motion in subjects with dynamic instrumentation [Срок оценки: [12 months]]
• Change in Intervertebral Disc Height [Срок оценки: [12 months]]
• Assessment of Intervertebral Disc Degeneration [Срок оценки: 12 months]
• Cervical and segmental lordosis assessment (for Cervical Spinal Instrumentation and Fusion Systems) [Срок оценки: [12 months]]
• Lordosis restoration and sagittal balance assessment (for Thoracolumbar Spinal Instrumentation and Fusion Systems) [Срок оценки: [12 months]]
• Incidence of adverse events and complications [Срок оценки: [12 months]]

Вторичные конечные точки (4)

• Clinical outcome assessment using Odom's Criteria [Срок оценки: [12 months]]
• Assessment of pain using Visual Analog Scale (VAS) [Срок оценки: [12 months]]
• Assessment of health-related quality of life with SF-12 [Срок оценки: [12 months]]
• Patient satisfaction assessment [Срок оценки: [12 months]]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 3 центра

• Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Neuros — Izmir
• Demokrasi University Buca Seyfi Demirsoy Training and Research Hospital, Department of Neu — Izmir
• Van Yuzuncu Yil University Dursun Odabas Medical Center, Department of Neurosurgery — Van

Идентификаторы

NCT: NCT07615491 · INFO SPINE · 2025-223

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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