CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
brief summary
The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.
detailed description
The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.
The purpose of this post market prospective cohort study is to obtain longer-term clinical and radiographic data on the safety and effectiveness of CERAMENT G as part of the surgical treatment of Osteomyelitis in a single-stage procedure.
Detailed questions to be answered are:
1. What is the nature, severity, and frequency of incomplete new bone formation? 2. What is the nature, severity, and frequency of the risks of probable adverse events and serious adverse events associated with incomplete new bone formation, including pathologic fractures and reinfection?
official title
A Post-Market Prospective Cohort Study on Subjects Receiving CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure