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

Launched by BONESUPPORT AB · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a treatment called CERAMENT G during surgery to help patients with osteomyelitis, which is a serious bone infection. The trial will look at how effective CERAMENT G is when used in a single operation to manage bone defects after the infection has been removed. Patients who might be eligible for this study are adults between the ages of 65 and 74 who have had symptoms of osteomyelitis for at least six months and have specific signs of infection, such as pus or the presence of a draining sinus.

If you choose to participate in this trial, you can expect to undergo surgery where CERAMENT G will be used to help fill any gaps left in the bone after the infection is cleared. This study is not yet recruiting participants, so there is no immediate need to take action, but it is important to know that people who have certain conditions, such as allergies to specific medications or significant bone loss, may not be eligible to join. Overall, this trial aims to improve the way osteomyelitis is treated and could benefit future patients facing this challenging condition.

Gender

ALL

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