Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.
ConditionOsteomyelitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiocomposites Ltd
About this trial
The purpose of this trial is to determine if genex with gentamicin (genex G) an antibiotic loaded bone void filler, works to treat and is a safe option as part of the surgical treatment of osteomyelitis in the extremities.
Eligibility criteria
Qualifiers
Patient with osteomyelitis of the extremities, who have failed antibiotic therapy and are requiring surgical intervention (unresolved osteomyelitis), Cierny-Mader classification of osteomyelitis grades I-IV. Patients presenting with Cierny-Mader grades I-II will be required to have a defect created as part of debridement surgery
Patients at least 18 years of age *1
Patient willing and able to provide written informed consent
Patient geographically stable and able to comply with the required follow-up visits and testing schedule as assessed by the investigator
Disqualifiers
Patients diagnosed with acute osteomyelitis
Patients with Cierny-Mader grades I-II who are unable to have a defect created during debridement surgery
Renal failure or documented chronic kidney disease with serum creatinine ≥3.5 mg/dL (309umol/L) or being treated with dialysis
Participants with a terminal or palliative diagnosis (e.g. terminal cancer diagnosis) deemed to have less than 1 year life expectancy by their health care team
Trial design
Treatments tested in this trial
- genex with gentamicin (genex G)
Treatment groups
139 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov