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PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials (INFO SPINE)

22. maj 2026 opdateret af: Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

561

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Burak Tülü, Sponsor's Representative
  • Telefonnummer: +90 (236) 213 10 14
  • E-mail: b.tulu@metrosan.com.tr

Studiesteder

  • Tyrkiet (Türkiye)
      • Izmir, Tyrkiet (Türkiye), 35150
        • Rekruttering
        • Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Neurosurgery
        • Kontakt:
          • Hasan Kamil Sucu, Professor
          • Telefonnummer: +90 (505) 211 8744
          • E-mail: hksucu@gmail.com
        • Ledende efterforsker:
          • Hasan Kamil Sucu, Professor
        • Underforsker:
          • Ismail Ertan Sevin, Asst. Prof.
      • Izmir, Tyrkiet (Türkiye), 35390
        • Ikke rekrutterer endnu
        • Demokrasi University Buca Seyfi Demirsoy Training and Research Hospital, Department of Neurosurgery
        • Kontakt:
        • Ledende efterforsker:
          • Gorkem Yavas, Asst. Prof.
      • Van, Tyrkiet (Türkiye), 65000
        • Ikke rekrutterer endnu
        • Van Yuzuncu Yil University Dursun Odabas Medical Center, Department of Neurosurgery
        • Kontakt:
        • Ledende efterforsker:
          • Mehmet Edip Akyol, Assoc. Prof.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients aged 18 years or older who underwent cervical or thoracolumbar spinal instrumentation and/or fusion surgery under current medical practice with appropriate indications, in whom at least one of the investigational devices was used, and who meet all inclusion and no exclusion criteria. The study will enroll a total of 561 subjects across 17 product groups (33 subjects per group, accounting for a 10% dropout rate) at 3 centers in Turkey.

All patients who underwent reverse shoulder arthroplasty or hemiarthroplasty using Tıpmed™ Primary Hip Prosthesis Systems, who were informed about this study and voluntarily agreed to participate will be included.

Beskrivelse

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.)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Cervical Interbody Fusion Cages (Titanium)
Subjects undergoing surgery with "Titania® Cervical Interbody Fusion Cages (Titanium)" will be followed for 12 months.
Enhed: 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.
Cervical Interbody Fusion Cages (PEEK)
Subjects undergoing surgery with "Titania® Cervical Interbody Fusion Cages (PEEK)" will be followed for 12 months.
Enhed: 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.
Posterior Cervical Stabilization Systems
Subjects undergoing surgery with "Titania® Posterior Cervical Stabilization Systems" will be followed for 12 months.
Enhed: 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.
Cervical Plate Systems
Subjects undergoing surgery with "Titania® Cervical Plate System" will be followed for 12 months.
Enhed: 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.
Cervical Dynamic Stabilization Systems (Elastic Rod)
Subjects undergoing surgery with "Titania® Cervical Dynamic Stabilization Systems (Elastic Rod)" will be followed for 12 months.
Enhed: 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.
Cervical Disc Prosthesis (Titanium)
Subjects undergoing surgery with "Titania® Cervical Disc Prosthesis (Titanium)" will be followed for 12 months.
Enhed: 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.
Cervical Disc Prosthesis (PEEK)
Subjects undergoing surgery with "Titania® Cervical Disc Prosthesis (PEEK)" will be followed for 12 months.
Enhed: 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.
Lumbar Interbody Fusion Cages (Titanium)
Subjects undergoing surgery with "Titania® Lumbar Interbody Fusion Cages (Titanium)" will be followed for 12 months.
Enhed: 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.
Lumbar Interbody Fusion Cages (PEEK)
Subjects undergoing surgery with "Titania® Lumbar Interbody Fusion Cages (PEEK)" will be followed for 12 months.
Enhed: 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.
Interspinous Fusion Device (Titanium)
Subjects undergoing surgery with "Titania® Interspinous Fusion Device (Titanium)" will be followed for 12 months.
Enhed: 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.
Posterior Thoracolumbar Stabilization Systems
Subjects undergoing surgery with "Titania® Posterior Thoracolumbar Stabilization Systems" will be followed for 12 months.
Enhed: Titania® Posterior Thoracolumbar Stabilization Systems
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.
Posterior Thoracolumbar Clamp Systems
Subjects undergoing surgery with "Titania® Posterior Thoracolumbar Clamp Systems" will be followed for 12 months.
Enhed: Titania® Posterior Thoracolumbar Clamp Systems
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.
Thoracolumbar Dynamic Stabilization Systems (Elastic Rod)
Subjects undergoing surgery with "Titania® Thoracolumbar Dynamic Stabilization Systems (Elastic Rod)" will be followed for 12 months.
Enhed: Titania® Thoracolumbar 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.
Synthetic Bone Grafts (Cervical Application)
Subjects undergoing surgery with "Bonegraft® Synthetic Bone Grafts" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., NDI scores) in the cervical region.
Enhed: Bonegraft® Synthetic Bone Grafts
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.
Synthetic Bone Grafts (Thoracolumbar Application)
Subjects undergoing surgery with "Bonegraft® Synthetic Bone Grafts" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the thoracolumbar region.
Enhed: Bonegraft® Synthetic Bone Grafts
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.
Bone Cement (Cervical Application)
Subjects undergoing surgery with "Bonegraft® Synthetic Bone Cement" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the cervical region.
Enhed: Bonegraft® Bone Cement
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.
Bone Cement (Thoracolumbar Application)
Subjects undergoing surgery with "Bonegraft® Synthetic Bone Cement" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the thoracolumbar region.
Enhed: Bonegraft® Bone Cement
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Neck Disability Index (NDI) score from baseline (for Cervical Spinal Instrumentation and Fusion Systems)
Tidsramme: [12 months]
The NDI is used to evaluate neck-pain-related disability. It consists of 10 items, each scored from 0 to 5. While the total raw score ranges from 0 to 50, results are expressed as a percentage (0-100%) for clinical evaluation, consistent with the referenced literature (Heller et al., 2009). Following clinical benchmarks, a reduction of ≥15% in the NDI score at the 12th-month follow-up compared to baseline is defined as a successful clinical improvement.
[12 months]
Change in Oswestry Disability Index (ODI) score from baseline (for Thoracolumbar Spinal Instrumentation and Fusion Systems)
Tidsramme: [12 months]

The ODI is used to assess the impact of thoracolumbar pain on daily life activities (personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and travel). It consists of 10 items, each scored from 0 to 5. The total score is calculated using the formula: (total score x 100) / (5 x number of questions answered), resulting in a scale from 0 (best) to 100 (worst). Evaluations will be performed at baseline (pre-op) and at each follow-up visit (Day 12, Week 6, and Months 3, 6, and 12).

A reduction of ≥15 points in the ODI score at the 12th-month follow-up compared to baseline is defined as a successful clinical improvement.
[12 months]
Fusion rate for Spinal Fusion Systems
Tidsramme: [12 months]

Fusion status will be evaluated using radiographs and/or CT scans (if available) at each postoperative follow-up visit. The assessment is based on the presence of a continuous trabecular bone bridge between the vertebral bodies. Fusion will be categorized into three groups:

Solid Fusion: Presence of a continuous bone bridge between the vertebrae.

Fibrous Fusion: Absence of a continuous bone bridge, but no signs of instability (translation < 3 mm on dynamic radiographs).

Non-fusion: Absence of a continuous bone bridge along with abnormal motion (> 3 mm translation on radiographs).

The evaluation will be concluded once solid fusion is achieved.
[12 months]
Adjacent segment motion in subjects with dynamic instrumentation
Tidsramme: [12 months]
In subjects undergoing dynamic posterior stabilization, motion at the adjacent segments will be evaluated using flexion and extension radiographs (if available) at all follow-up visits. The primary assessment involves measuring the differences in the disc space angles. These measurements will be compared with baseline (preoperative) values to monitor changes in adjacent segment mobility over the 12-month follow-up period.
[12 months]
Change in Intervertebral Disc Height
Tidsramme: [12 months]
The intervertebral disc height will be evaluated at each follow-up visit using the Dabbs method. The assessment is based on the average of the measurements taken from the anterior and posterior regions of the disc space, expressed in millimeters (mm) by the formula (A+B)/2. These radiological measurements will be compared with preoperative (baseline) values to identify any changes in disc height throughout the 12-month follow-up period.
[12 months]
Assessment of Intervertebral Disc Degeneration
Tidsramme: 12 months
Intervertebral disc degeneration will be evaluated at each follow-up visit using the Pfirrmann Classification system. This system grades the degree of disc degeneration based on MRI (Magnetic Resonance Imaging) findings, focusing on disc structure, distinction between nucleus and annulus, signal intensity, and disc height. The scale ranges from Grade I (normal disc structure with high signal intensity) to Grade V (severe degeneration with collapsed disc space). Categorical grades obtained at each control period will be compared with baseline (preoperative) status to monitor the progression or stabilization of disc degeneration throughout the 12-month follow-up period, where a shift toward higher grades signifies worsening of degeneration.
12 months
Cervical and segmental lordosis assessment (for Cervical Spinal Instrumentation and Fusion Systems)
Tidsramme: [12 months]
Cervical and segmental lordosis will be evaluated at each follow-up visit and compared with preoperative measurements. Lateral radiographs of the cervical spine will be used to measure lordosis angles using the Cobb angle method. This assessment aims to monitor the maintenance or restoration of the sagittal alignment of the cervical spine and the specific treated segments throughout the 12-month follow-up period.
[12 months]
Lordosis restoration and sagittal balance assessment (for Thoracolumbar Spinal Instrumentation and Fusion Systems)
Tidsramme: [12 months]
Sagittal balance and lordosis restoration will be evaluated using full-spine radiographs (tele-radiographies, if available) at baseline and each follow-up visit (Day 12, Week 6, Months 3, 6, and 12). Clinical success will be assessed based on the Schwab sagittal alignment classification parameters. This assessment is a categorical evaluation based on whether patients achieve the predefined optimal correction thresholds for three key spinal parameters: 1) Sagittal Vertical Axis (SVA) < 50 millimeters, 2) Pelvic Tilt (PT) < 20 degrees, and 3) Pelvic Incidence minus Lumbar Lordosis (PI-LL) mismatch within ±9 degrees. At each follow-up period, patients will be categorized into two groups: those who achieve all these optimal parameters and those who do not. Patients meeting all three thresholds will be classified as 'successful' according to the Schwab criteria.
[12 months]
Incidence of adverse events and complications
Tidsramme: [12 months]
Safety data will be collected by recording all adverse events (AEs) and complications encountered during the 12-month follow-up period. This includes intraoperative complications, device-related failures, and any postoperative adverse events (e.g., infection, neurological deficit, or reoperation).
[12 months]

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical outcome assessment using Odom's Criteria
Tidsramme: [12 months]
Patient clinical outcomes will be evaluated at each follow-up visit using Odom's Criteria, which classifies results as 'Excellent', 'Good', 'Fair', or 'Poor' based on symptom relief and the ability to perform daily activities. Clinical success is defined as the proportion of subjects achieving 'Excellent' or 'Good' scores, representing significant improvement compared to baseline.
[12 months]
Assessment of pain using Visual Analog Scale (VAS)
Tidsramme: [12 months]
Pain intensity and changes in pain levels will be evaluated at each follow-up visit using the Visual Analog Scale (VAS) and compared with baseline measurements. Patients mark their pain level on a 100 mm (or 10 cm) line, where 0 represents no pain and 100 represents the worst pain. A decrease of ≥20 mm (or 2 cm) in pain intensity at the 12th-month follow-up compared to baseline is considered a successful clinical outcome.
[12 months]
Assessment of health-related quality of life with SF-12
Tidsramme: [12 months]
Health-related quality of life and changes in quality of life perception will be evaluated at each follow-up visit using the SF-12 Health Survey and compared with baseline measurements. Each domain of the survey is evaluated independently. Scores for each domain range from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.
[12 months]
Patient satisfaction assessment
Tidsramme: [12 months]
Patient satisfaction will be evaluated at the final follow-up visit (12 months) using a 3-point Likert scale based on three specific questions directed to the subject. The scale consists of three response options: 'Yes', 'Undecided', and 'No'. The proportion of patients responding 'Yes' to the satisfaction questions will be analyzed to determine the overall treatment satisfaction rate.
[12 months]

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Samarbejdspartnere

Bonegraft Biyolojik Malzemeler San. ve Tic. A.S.

Efterforskere

  • Studieleder: Hasan Kamil Sucu, Professor, Izmir Katip Celebi University Ataturk Training and Research Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. april 2026

Primær færdiggørelse (Anslået)

26. april 2028

Studieafslutning (Anslået)

26. september 2028

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

22. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • INFO SPINE
  • 2025-223 (Anden identifikator: Turkish Medicines and Medical Devices Agency (TITCK))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Data will not be shared due to confidentiality and intellectual property policies of the sponsor.

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