An observational study in Osteomyelitis, sponsored by BONESUPPORT AB. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by BONESUPPORT AB · Observational
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 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:
105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.
This study's planned enrollment of 128 is above the median of 86 across 41 observational studies indexed under Osteomyelitis.
Browse Osteomyelitis studies →BONESUPPORT AB is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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Patients enrolled post-operatively with Osteomyelitis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects meeting the following inclusion criteria are to be included in the analysis:
Symptoms for a minimum of six months with clinical and radiological features accompanied by at least one of the following:
Exclusion Criteria:
The subject will be excluded from the study if:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects receiving CERAMENT G as part of the surgical treatment of Osteomyelitis
Device: CERAMENT G
CERAMENT G is intended for use as a bone void filler as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) as part of the surgical treatment of osteomyelitis. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing.
Composite Endpoint
Overall subject success requires all four of the following at 36 months post-op: * absence of a reinfection of the original site of osteomyelitis; * absence of purulent drainage and wound dehiscence/breakdown * absence of a secondary surgical intervention, e.g., grafting or removal of residual CERAMENT G at the original site; and, * a lack of serious adverse events associated with incomplete new bone formation, including pathologic fracture of the treated limb
Time frame: 36 months
Co-Primary Endpoint
A trend showing increasing new bone formation and decreasing CERAMENT G as determined by a comparison of baseline and interim post-operative timepoint radiographic evaluations out to 36 months post-operative
Time frame: 36 months
Radiographic Succcess
Radiographic success at 36 months, defined as CERAMENT G resorption and new bone formation (a minimum of mean void-filling of 74% in the subject population) as determined by comparison of the immediate post-op radiographs to those at 36 months
Time frame: 36 months
Clinical Success
Clinical success at 36 months, defined as: Maintenance or improvement in function (i.e., no decrease of PRO(s) in the SF-12 score between post-operative and 36 months follow-up)
Time frame: 36 months
Plan to share: No
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