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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Study 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

Primary outcome measure(s)

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

Trial sites (3)

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