Actively Recruiting
A Prospective, Multi-Center, Observational Post-Market Clinical Follow-Up Study Evaluating the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials Used in Spinal Instrumentation and Fusion Surgery
Led by Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co. · Updated on 2026-05-29
561
Participants Needed
3
Research Sites
21 weeks
Total Duration
On this page
Sponsors
M
Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.
Lead Sponsor
B
Bonegraft Biyolojik Malzemeler San. ve Tic. A.S.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multi-center observational study to collect additional safety and performance data on CE-marked Titania spinal instrumentation and fusion systems, as well as Bonegraft bone filling materials. The study focuses on patients undergoing spinal surgery for various conditions and aims to evaluate short-term safety and effectiveness over 12 months, identify new side effects, monitor complications, and assess risks using real-world evidence. All devices are used as intended within routine clinical practice. The study observes 17 distinct product groups independently, including various types of cervical and lumbar fusion cages, stabilization systems, disc prostheses, interspinous devices, dynamic stabilization systems, and bone filling materials. Participants receive these devices based on their physician's judgment, with no additional interventions beyond standard care. Each participant is followed for 12 months after surgery, with data collected retrospectively and prospectively through routine clinical visits. Participants will be evaluated at post-operative Day 12, Week 6, and Months 3, 6, and 12 during routine visits. Data collected include clinical outcomes such as changes in Neck Disability Index and Oswestry Disability Index scores, fusion rates, pain assessment, quality of life, and incidence of adverse events. The study runs for a total of 29 months, including enrollment, follow-up, and data analysis, adhering to relevant medical device regulations and ethical guidelines.
CONDITIONS
Brief Title
PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Skeletally mature
- Male or female
- Undergone spinal surgery (cervical or thoracolumbar) for any indication under current medical practice
- Use of Titania spinal stabilization/fusion systems and/or BONEGRAFT bone cements or bone graft materials during the operation
- No general health conditions that contraindicate surgery
- No legal restrictions such as military service or incarceration
- Signed and dated Informed Consent Form
You will not qualify if you...
- 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 or diseases affecting bone metabolism
- Known allergy or hypersensitivity to PEEK, Titanium, or PMMA
- Congenital abnormalities, tumors, or conditions preventing secure implant fixation or likely to shorten implant life
- Inadequate tissue coverage at the surgical site
- Legal restrictions such as military personnel or prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Single surgical procedure according to routine clinical practice
Participants who undergo routine spinal surgery with METROSAN spinal systems and BONEGRAFT filling materials are observed as part of routine clinical care. No additional interventions or procedures beyond standard care are performed.
1 surgical visit (in-person)
Duration - 12 months
Participants are followed during routine clinical visits to monitor safety and clinical performance of the implanted spinal devices and bone graft materials.
Visits at approximately post-operative Day 12 (±5 days), Week 6, and Months 3, 6, and 12
Trial Site Locations
Total: 3 locations
1
Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Neurosurgery
Izmir, Turkey (Türkiye), 35150
Actively Recruiting
2
Demokrasi University Buca Seyfi Demirsoy Training and Research Hospital, Department of Neurosurgery
Izmir, Turkey (Türkiye), 35390
Not Yet Recruiting
3
Van Yuzuncu Yil University Dursun Odabas Medical Center, Department of Neurosurgery
Van, Turkey (Türkiye), 65000
Not Yet Recruiting
Research Team
B
Burak Tülü, Sponsor's Representative
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
17
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