Study of Safety and Effectiveness of METROSAN Titania Spinal Systems and BONEGRAFT Bone Filling Materials in Spinal Surgery

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 physicians 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.

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