Using CERAMENT G during single-stage surgery to treat chronic osteomyelitis

A Post-Market Prospective Cohort Study on Subjects Receiving CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure

This test uses CERAMENT G to fill bone defects during a single-stage operation for people with chronic, severe osteomyelitis to help bone heal and lower the risk of reinfection.

Quick facts

• Study type: Observational
• Enrollment: 128 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bonesupport Ab (Industry-sponsored)
• Locations: 1 site (Oxford)
• Trial ID: NCT06555848 on ClinicalTrials.gov

What this trial studies

This is a post‑market prospective cohort following patients who received CERAMENT G as a bone void filler during a single‑stage surgical excision of osteomyelitis. Eligible patients have chronic infection (symptoms ≥6 months) and Cierny‑Mader grade III or IV disease requiring dead‑space management after debridement. The study collects clinical and radiographic outcomes over time to document new bone formation and capture adverse events including reinfection and pathological fracture. The design is observational, aiming to provide longer‑term safety and effectiveness data in routine surgical practice.

Who should consider this trial

Good fit: Ideal candidates are adults with chronic (≥6 months) Cierny‑Mader grade III or IV osteomyelitis who require dead‑space management after surgical debridement and who have supporting signs such as a draining sinus, abscess/pus, positive histology, or concordant cultures.

Not a fit: Patients with acute or early‑stage osteomyelitis (Cierny‑Mader I–II), those who cannot undergo adequate surgical debridement, or those who do not meet the specific inclusion criteria (for example symptoms <6 months without positive histology or sinus) are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the approach could improve local bone healing after debridement and reduce rates of reinfection and the need for additional surgeries.

How similar studies have performed: Previous observational and post‑market reports of gentamicin‑loaded CERAMENT formulations have shown encouraging bone fill and infection control in single‑stage management of chronic osteomyelitis, although randomized controlled data are limited.

Eligibility criteria

Inclusion Criteria:

Subjects meeting the following inclusion criteria are to be included in the analysis:

1. 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.
2. Symptoms for a minimum of six months with clinical and radiological features accompanied by at least one of the following:

   1. the presence of a sinus
   2. the presence of an abscess or intra-operative pus
   3. the presence of positive supportive histology
   4. 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:

The subject will be excluded from the study if:

1. 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)
2. Those unable to give informed consent for inclusion in the trial, or those not willing to be included
3. A known allergy or reaction to gentamicin or calcium sulfate
4. Treatment with a combination of different antibiotic-eluting bone graft substitutes
5. They have a segmental bone defect \> 1cm
6. Infection of the spine

Where this trial is running

Oxford

• Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHS — Oxford, United Kingdom (Recruiting)

Conditions Osteomyelitis