Status:
RECRUITING
CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
Lead Sponsor:
BONESUPPORT AB
Conditions:
Osteomyelitis
Eligibility:
All Genders
18+ years
Brief 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.
Detailed Description
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. The purpose of this post market prospecti...
Eligibility Criteria
Inclusion
- Subjects meeting the following inclusion criteria are to be included in the analysis:
- 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
- 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
Key Trial Info
Start Date :
June 2 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2032
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06555848
Start Date
June 2 2025
End Date
October 1 2032
Last Update
October 3 2025
Active Locations (1)
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1
Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHS
Oxford, United Kingdom, OX37HE