Clinical trial NCT06555848: CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
Official title: A Post-Market Prospective Cohort Study on Subjects Receiving CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteomyelitis
Lead sponsor: BONESUPPORT AB
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled post-operatively with Osteomyelitis

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 prospective cohort study is to obtain longer-term clinical and radiographic data on the safety and effectiveness of CERAMENT G as part of the surgical treatment of Osteomyelitis in a single-stage procedure.

Detailed questions to be answered are:

1. What is the nature, severity, and frequency of incomplete new bone formation?
2. What is the nature, severity, and frequency of the risks of probable adverse events and serious adverse events associated with incomplete new bone formation, including pathologic fractures and reinfection?

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

Primary outcomes:
measure: Composite Endpoint
timeFrame: 36 months
measure: Co-Primary Endpoint
timeFrame: 36 months
Secondary outcomes:
measure: Radiographic Succcess
timeFrame: 36 months
measure: Clinical Success
timeFrame: 36 months
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHS
Study officials:
References: