Actively Recruiting
Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.
Led by Biocomposites Ltd · Updated on 2026-05-11
139
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Osteomyelitis of the extremities present for at least 6 months requiring surgical intervention (Cierny-Mader grades I-IV). Patients with grades I-II must have a defect created during surgery
- At least 18 years old (ages 18-22 require x-ray confirmation of bone maturity)
- Willing and able to provide written informed consent
- Geographically stable and able to attend required follow-up visits and tests
- Ability to achieve proper surgical soft tissue coverage of the wound through closure or reconstruction
You will not qualify if you...
- Patients with Cierny-Mader grades I-II unable to have a defect created during surgery
- Renal failure or chronic kidney disease with serum creatinine ≥3.5 mg/dL or on dialysis
- Terminal or palliative diagnosis with less than 1 year life expectancy
- Uncontrolled diabetes with hemoglobin A1c >10%
- Pre-existing calcium metabolism disorder
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- History of allergy or contraindication to the device or its ingredients (calcium phosphate, β-tricalcium phosphate, aminoglycoside antibiotics)
- Participation in another investigational drug/device study within the last 60 days or prior enrollment in this study
- Clinically significant or unstable medical or surgical conditions that may prevent safe participation
- Current untreated cancer or ongoing radiation or chemotherapy
- Active substance abuse within last 2 years meeting severe criteria
- Current user of nicotine products
- Currently incarcerated
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
OrthoIndy
Indianapolis, Indiana, United States, 46278
Actively Recruiting
Research Team
K
Keira Watts, PHD
CONTACT
S
Simal Trikam
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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