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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.
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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:
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Inclusion criteria
Subjects meeting the following inclusion criteria are to be included in the analysis:
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:
Exclusion criteria
The subject will be excluded from the study if:
128 participants in 1 patient group
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Central trial contact
Michael Diefenbeck, MD; Kursheed Khan, MD
Data sourced from clinicaltrials.gov
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