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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
genex with gentamicin (genex G)
Devicegenex with gentamicin will be implanted during debridement surgery
Treatment groups
139 Participants
are divided into 1 treatment groupGroup A: Single ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
No further requirement for antibiotic treatment due to persisting symptoms of infection at the index site (i.e., additional antibiotics prescribed following completion of the initial systemic antibiotics prescribed post surgery.
Further requirement for antibiotic treatment due to persisting symptoms of infection at the site of treatment will be assessed at Month 12.
Time frame
Month 122
No further surgical interventions required due to infection at the index site.
Need for further surgical interventions required due to infection at the index site will be assessed at Month 12.
Time frame
Month 123
No recurrence of sinus formation at the index site.
Recurrence of sinus formation at the index site will be assessed by a non-contrast CT scan at week 2 \& Month 12. Clinical endpoint assessments will also be used to measure this at post operative follow-up visits and will be assessed at Month 12.
Time frame
Month 12Secondary outcomes
1
No additional requirement for antibiotic treatment due to persisting symptoms of infection at the treatment site, i.e., additional antibiotics prescribed following completion of the initial systemic antibiotics prescribed post-surgery.
Further requirement for antibiotic treatment due to persisting symptoms of infection at the site of treatment will be assessed at Month 24.
Time frame
Month 242
No radiographic evidence of post op fractures.
Radiographic evidence of post-operative fractures will be evidenced by X-ray \& CT evaluations and assessed at Month 24.
Time frame
Month 243
Radiographic evidence of new bone healing.
Radiographic evidence of new bone healing will be evidenced by X-ray and CT evaluations and assessed at Month 24.
Time frame
Month 244
No recurrence of sinus formation at the treatment site.
Recurrence of sinus formation at the index site will be assessed by contrast enhanced CT evaluation and Clinical endpoint assessments measured at Month 24.
Time frame
Month 24Sponsors and contacts
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Source ClinicalTrials.gov