Actively Recruiting
A Post-Market Prospective Cohort Study on Subjects Receiving CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
Led by BONESUPPORT AB · Updated on 2026-05-04
128
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients receiving CERAMENT G after surgical excision of osteomyelitis with Cierny-Mader classification grades III or IV
- Require dead-space management of a bone defect following surgical removal of infection
- Symptoms for at least six months with clinical and radiological features plus at least one of: presence of sinus, abscess or intra-operative pus, positive supportive histology, or two or more microbiological cultures with indistinguishable organisms
- In cases of negative cultures, inclusion requires positive supportive histology combined with draining sinus or intra-operative pus
- Infected non-unions included only if bone loss is less than 1 cm after debridement and excision
You will not qualify if you...
- Skeletal immaturity shown by incompletely fused growth plates on prior x-rays
- Unable or unwilling to give informed consent for the trial
- Known allergy or reaction to gentamicin or calcium sulfate
- Treatment with a combination of different antibiotic-eluting bone graft substitutes
- Segmental bone defect greater than 1 cm
- Infection of the spine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure plus immediate recovery period
Participants undergo a single-stage surgical procedure where CERAMENT G is used as part of the treatment of osteomyelitis.
1 surgical visit and immediate post-operative care
Duration - Up to 36 months
Participants are followed over time to monitor safety and effectiveness of CERAMENT G including clinical and radiographic outcomes.
Regular follow-up visits over 36 months
Trial Site Locations
Total: 1 location
1
Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHS
Oxford, United Kingdom, OX37HE
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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