Study of CERAMENT G Device for Surgical Treatment of Osteomyelitis in a Single-Stage Procedure to Assess Long-Term Safety and Effectiveness

What this Trial Is About

Researchers are studying the use of CERAMENT G as part of the surgical treatment for osteomyelitis, a bone infection, in a single-stage procedure. This prospective cohort study aims to collect longer-term clinical and radiographic data to evaluate the safety and effectiveness of CERAMENT G in this treatment. The study focuses on understanding the nature, severity, and frequency of incomplete new bone formation and associated risks like fractures and reinfection. Participants will receive CERAMENT G, a device used as a bone void filler alongside standard antibiotic therapy and surgical removal of infected bone. CERAMENT G releases gentamicin to help reduce the recurrence of infection from gentamicin-sensitive bacteria, supporting bone healing. The study observes subjects who undergo this single-stage surgical treatment with CERAMENT G. During the study, participants will be monitored for up to 36 months to assess outcomes including composite and co-primary endpoints related to bone healing and infection control. Clinical and radiographic success will be evaluated through follow-up assessments. The research collects detailed data on safety and effectiveness to better understand the benefits and risks of CERAMENT G in osteomyelitis treatment.

CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure