Barcelos

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.

Researchers are evaluating the performance and safety of Neocement4 Inject P, a synthetic bone substitute designed to improve bone repair and regeneration. This biomaterial combines specific calcium phosphates with chitosan and a citric acid and glucose solution. The study aims to collect real-world clinical data on the devices use for filling bone defects caused by surgery or trauma, supporting its clinical evaluation for regulatory submission under the Medical Device Regulation EU 2017745. Neocement4 Inject P is applied during surgery to fill voids or gaps in bones that are not crucial to bone stability. Multiple units may be used depending on the lesion size. The device is expected to be partially or fully absorbed within about 6 months. This is a prospective observational post-market study with no additional risks or direct benefits for patients. The study does not include any new uses or design changes for the device. Participants will be followed according to standard medical care for one year, with clinical data collected at enrollment around 6 weeks after surgery, and follow-up visits at 3 months, 6 months, and optionally 12 months. Researchers will assess device performance, safety endpoints, patient quality of life using the SF-36 questionnaire, and surgeon satisfaction. This active safety monitoring aims to ensure ongoing device effectiveness and identify any emerging risks.