CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
ConditionOsteomyelitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBONESUPPORT AB
About this trial
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 criteria
Qualifiers
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.
the presence of a sinus
the presence of an abscess or intra-operative pus
the presence of positive supportive histology
Disqualifiers
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
Trial design
Treatments tested in this trial
- CERAMENT G
Treatment groups
128 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov