Surgical management of Osteomyelitis using CERAMENT G
Research type
Research Study
Full title
Certitude - A Post-Market Prospective Cohort Study on Subjects Receiving CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-stage Surgical Procedure
IRAS ID
339381
Contact name
Jamie Ferguson
Contact email
Sponsor organisation
BoneSupport AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 1 months, 1 days
Research summary
CERAMENT G, is an implantable bone void filler indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a defect in the bone following infection excision. Whilst this treatment has been previously studied, 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?REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
24/NE/0167
Date of REC Opinion
17 Sep 2024
REC opinion
Favourable Opinion