CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
A Post-Market Prospective Cohort Study on Subjects Receiving CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
BONESUPPORT AB
128 participants
Jun 2, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria6
- Patients receiving CERAMENT G subsequent to surgical excision of osteomyelitis, with Cierny-Mader classification grades III or IV, who require dead-space management of a bone defect following surgical debridement and excision of infection.
- Symptoms for a minimum of six months with clinical and radiological features accompanied by at least one of the following:
- the presence of a sinus
- the presence of an abscess or intra-operative pus
- the presence of positive supportive histology
- two or more microbiological cultures with indistinguishable organisms (defined as cultures resulting in identification of the same microbe (e.g., Staph aureus) with similar antimicrobial sensitivity) Notes: In cases where cultures are negative, a patient will be included in the study only if there is positive supportive histology combined with the presence of a draining sinus or intra-operative pus. Infected non-unions will be included only if the bone loss is \< 1cm after debridement and excision of bone has been performed.
Exclusion Criteria7
- The subject will be excluded from the study if:
- Skeletal immaturity, defined as pre-operative/ screening radiology with evidence of incompletely fused physes. (determined by their previous x-rays which are taken as part of their admission, unrelated to the study)
- Those unable to give informed consent for inclusion in the trial, or those not willing to be included
- A known allergy or reaction to gentamicin or calcium sulfate
- Treatment with a combination of different antibiotic-eluting bone graft substitutes
- They have a segmental bone defect \> 1cm
- Infection of the spine
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06555848