CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
Condition(s) studied
Investigational drug(s) / intervention(s)
CERAMENT G: CERAMENT G is intended for use as a bone void filler as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) as part of the surgical treatment of osteomyelitis. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing.
Study 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.
Eligibility
Primary outcome measure(s)
- Composite Endpoint — 36 months
Overall subject success requires all four of the following at 36 months post-op: * absence of a reinfection of the original site of osteomyelitis; * absence of purulent drainage and wound dehiscence/breakdown * absence of a secondary surgical intervention, e.g., grafting or removal of residual CERAMENT G at the original site; and, * a lack of serious adverse events associated with incomplete new bone formation, including pathologic fracture of the treated limb - Co-Primary Endpoint — 36 months
A trend showing increasing new bone formation and decreasing CERAMENT G as determined by a comparison of baseline and interim post-operative timepoint radiographic evaluations out to 36 months post-operative
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHS | Oxford | United Kingdom | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06555848 on ClinicalTrials.gov ↗ ← All trials in the UK