Evaluation of the Safety and Performance of the Neocement A Prospective Observational Study in Orthopaedic Area

What this Trial Is About

Researchers are collecting real-world clinical data to evaluate the performance and safety of Neocement, a synthetic bone substitute made primarily of calcium phosphates and chitosan. This device is designed for use by experienced orthopedic surgeons in bone grafting and is intended for adults over 18 years old. The study aims to provide clinical evidence to support the devices evaluation under the new Medical Device Regulation EU 2017745, focusing on its use in current clinical applications without introducing new populations or changes. Neocement is a Class III medical device meant for long-term implantation in contact with bone and surrounding tissues, applied through surgical methods. The cement is expected to be partially or fully resorbed, with effects predicted to occur around six months after implantation. This observational study involves monitoring patients treated with Neocement during routine clinical practice, without additional risks or direct benefits from participation. Participants will be followed as per standard medical care at their center for one year, with clinical data collected at four time points enrollment at approximately six weeks post-surgery, then at three months, six months, and if needed, twelve months. Researchers will assess performance and safety endpoints over these visits, along with quality of life surveys and surgeon satisfaction evaluations. This ongoing monitoring helps ensure the devices continued safety and effectiveness after market launch.

Evaluation of the Safety and Performance of the Neocement®