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.
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.
Study Type
OBSERVATIONAL
Enrollment
561
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Neurosurgery
Izmir, Turkey (Türkiye)
RECRUITINGDemokrasi University Buca Seyfi Demirsoy Training and Research Hospital, Department of Neurosurgery
Izmir, Turkey (Türkiye)
NOT_YET_RECRUITINGVan Yuzuncu Yil University Dursun Odabas Medical Center, Department of Neurosurgery
Van, Turkey (Türkiye)
NOT_YET_RECRUITINGChange in Neck Disability Index (NDI) score from baseline (for Cervical Spinal Instrumentation and Fusion Systems)
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.
Time frame: [12 months]
Change in Oswestry Disability Index (ODI) score from baseline (for Thoracolumbar Spinal Instrumentation and Fusion Systems)
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.
Time frame: [12 months]
Fusion rate for Spinal Fusion Systems
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.
Time frame: [12 months]
Adjacent segment motion in subjects with dynamic instrumentation
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.
Time frame: [12 months]
Change in Intervertebral Disc Height
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.
Time frame: [12 months]
Assessment of Intervertebral Disc Degeneration
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.
Time frame: 12 months
Cervical and segmental lordosis assessment (for Cervical Spinal Instrumentation and Fusion Systems)
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.
Time frame: [12 months]
Lordosis restoration and sagittal balance assessment (for Thoracolumbar Spinal Instrumentation and Fusion Systems)
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.
Time frame: [12 months]
Incidence of adverse events and complications
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).
Time frame: [12 months]
Clinical outcome assessment using Odom's Criteria
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.
Time frame: [12 months]
Assessment of pain using Visual Analog Scale (VAS)
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.
Time frame: [12 months]
Assessment of health-related quality of life with SF-12
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.
Time frame: [12 months]
Patient satisfaction assessment
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.
Time frame: [12 months]
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.