Evaluation of the Safety and Performance of the Neocement4 Inject P A Prospective Observational Study in Orthopaedic Area

What this Trial Is About

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.

Evaluation of the Safety and Performance of the Neocement® Inject P