RecruitingNot Applicable

CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure

United Kingdom128 participantsStarted 2025-06-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Composite Endpoint

Timeframe: 36 months

Co-Primary Endpoint

Timeframe: 36 months

Trial details

NCT IDNCT06555848

SponsorBONESUPPORT AB

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2031-10

View on ClinicalTrials.gov More Osteomyelitis trials