Zafra

Researchers are evaluating the safety and performance of TEKNIMED Spine range bone cements, including SPINEFIX, HIGH V+, OPACITY+, and F20, as well as their mixing and injection systems in spine surgery. These bone cements have been used for over 10 years, and their safety and effectiveness were previously supported by post-market surveillance and clinical studies. This study aims to confirm these results by collecting data in real-world clinical settings through a retrospective and prospective observational design involving multiple centers globally. The study involves procedures such as vertebroplasty, kyphoplasty, and pedicular screw augmentation, where a medical-grade bone cement mixture is injected to relieve pain and improve mechanical stability in fractured vertebrae or to strengthen pedicle screw fixation. The study includes patients treated with TEKNIMED bone cements either retrospectively or prospectively, with follow-up conducted according to local standard medical care. This single-arm, non-controlled study collects data from these routine treatments without altering patient care. Participants will be monitored for up to 24 months focusing on pain relief as the primary outcome. Data collection includes clinical assessments aligned with routine care, and the study observes safety and performance in typical medical practice. Patients are followed over time to assess outcomes like pain alleviation, mobility improvement, and any complications. The study duration varies depending on the timing of patient inclusion and treatment but encompasses both retrospective and ongoing prospective data gathering.