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: 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?
Study Type
OBSERVATIONAL
Enrollment
128
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.
Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHS
Oxford, United Kingdom
RECRUITINGComposite 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
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