Safety and Performance Study of TEKNIMED Spine Bone Cements and Injection Systems Used in Vertebroplasty, Kyphoplasty, and Pedicular Screw Augmentation Procedures

What this Trial Is About

This research aims to collect real-life clinical data on the safety and performance of TEKNIMEDs range of spine bone cements, including SPINEFIX, HIGH V, OPACITY, and F20, along with their mixing and injection systems. These bone cements have been used for over 10 years, and their safety and effectiveness have been supported by previous studies. The study focuses on vertebroplasty, kyphoplasty, and pedicle screw augmentation procedures, which are used to treat painful vertebral compression fractures and improve mechanical stability, especially in osteoporotic patients. The study observes patients treated with TEKNIMED spine bone cements during vertebroplasty and kyphoplasty procedures, where cement is injected into fractured vertebrae to relieve pain and stabilize the bone. It also includes pedicular screw augmentation, where cement is injected to strengthen screw fixation. The study is non-controlled, multicentric, and combines both retrospective and prospective data collection, following patients according to local standard medical care. Participants will be monitored over time with assessments focusing on pain relief, quality of life, patient satisfaction, vertebral stabilization, and pain medication use for up to 24 months. Safety is tracked through adverse event collection over 10 years. Data are gathered from clinical records without altering usual care. This approach will provide long-term insights into the real-world use of TEKNIMED spine bone cements in spine surgery.

Spine Bone Cements Outcomes - Post Market Follow-up