Actively Recruiting
Multi-center Single-arm Trial to Assess Safety and Effectiveness of Genex G in Surgical Treatment of Osteomyelitis of the Extremities
Led by Biocomposites Ltd · Updated on 2026-06-05
139
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of genex with gentamicin (genex G), an antibiotic-loaded bone void filler, to treat osteomyelitis in the extremities. This pivotal, multi-center, single-arm study includes patients with osteomyelitis classified from grades I to IV according to the Cierny-Mader system. The goal is to determine if genex G is a safe and effective part of surgical treatment for this condition, with participants followed for up to 24 months. All participants will undergo surgical debridement and receive genex G implanted during surgery to fill bone voids and support healing. They will also receive systemic antibiotics as clinically indicated by their treatment site. This study does not include a control group but compares results historically. The follow-up period extends to 24 months after surgery to monitor outcomes and safety. Participants will be assessed regularly throughout the study for infection recurrence, need for additional antibiotics or surgeries, bone healing, and any adverse events. Radiographic imaging and clinical examinations will evaluate bone formation and infection resolution. Quality of life will also be measured using the EQ-5D-5L questionnaire. The study aims to capture safety and effectiveness data over two years following treatment with genex G.
CONDITIONS
Brief Title
Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient diagnosed with osteomyelitis of the extremities (Cierny-Mader grades I-IV) who have failed antibiotic therapy and require surgery
- Patients at least 18 years old; ages 18-22 require confirmed skeletal maturity by radiographs
- Patient able and willing to provide written informed consent
- Patient geographically stable and able to comply with follow-up visits and testing
- Ability to achieve adequate surgical soft tissue coverage of the wound after surgery
You will not qualify if you...
- Patients with acute osteomyelitis
- Patients with Cierny-Mader grades I-II unable to have a defect created during surgery
- Renal failure or chronic kidney disease with serum creatinine 63.5 mg/dL or on dialysis
- Terminal or palliative diagnosis with less than 1-year life expectancy
- Uncontrolled diabetes (hemoglobin A1c >10%)
- Pre-existing calcium metabolism disorder
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- History of hypersensitivity to the device or its ingredients
- Participation in another investigational drug/device study within last 60 days or prior enrollment in this study
- Clinically significant or unstable medical/surgical condition precluding safe study participation
- Current untreated cancer or treatment with radiation or chemotherapy
- History of severe substance abuse within last 2 years
- Current user of nicotine-containing products
- Currently incarcerated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus immediate recovery period
Participants undergo surgical debridement and implantation of genex with gentamicin as part of their treatment for osteomyelitis of the extremities. They also receive systemic antibiotics as clinically indicated.
1 surgical visit and immediate post-operative monitoring
Duration - 24 months
Participants are followed up for 24 months to monitor infection resolution, bone healing, safety, and any additional treatment needs.
Multiple follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
OrthoIndy
Indianapolis, Indiana, United States, 46278
Actively Recruiting
Research Team
K
Keira Watts, PHD
S
Simal Trikam
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here