Genex with gentamicin for treating osteomyelitis of the arms and legs
A Multi-center, Single-arm, Historically Controlled Pivotal Trial, to Assess the Safety and Effectiveness of Genex G as Part of the Surgical Treatment of Osteomyelitis of the Extremities.
This trial tests whether Genex with gentamicin, an antibiotic-loaded bone void filler, can help adults with chronic osteomyelitis of the arms or legs when used during surgical treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 139 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biocomposites Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07270380 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, single-arm, historically controlled pivotal device study in which all participants with extremity osteomyelitis undergo surgical debridement and receive Genex with gentamicin as the bone void filler. Participants will also receive systemic antibiotics as clinically indicated per site-specific practice. The study enrolls adults with Cierny-Mader grade I–IV osteomyelitis (with a requirement to create a defect for grades I–II) and requires adequate soft tissue coverage after surgery. All participants are followed for 24 months to monitor safety and infection outcomes compared against historical controls.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) with at least six months of osteomyelitis in an arm or leg who need surgical debridement, can achieve adequate soft tissue coverage, and can comply with follow-up visits.
Not a fit: Patients who cannot have a defect created when required, cannot achieve adequate soft tissue coverage, are pediatric or skeletally immature, or have conditions best treated by alternative strategies may not benefit from this device.
Why it matters
Potential benefit: If successful, this approach could deliver high local antibiotic concentrations at the bone site to reduce infection recurrence and limit systemic antibiotic exposure.
How similar studies have performed: Other antibiotic-loaded bone void fillers using gentamicin or similar antibiotics have shown promising results in non-randomized series and device registries, but robust randomized or pivotal data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient with osteomyelitis of the extremities (for a minimum of 6 months) that requires surgical intervention (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 2. Patients at least 18 years of age \*1 3. Patient willing and able to provide written informed consent 4. Patient geographically stable and able to comply with the required follow-up visits and testing schedule as assessed by the investigator 5. Ability to achieve adequate surgical soft tissue coverage of the wound (primary tissue closure or surgical reconstruction including local and free soft tissue transfer) * 1 Patients between 18 and 22 years of age require confirmation of skeletal maturity as validated by radiographs of the bone to be treated. Exclusion Criteria: 1. Patients with Cierny-Mader grades I-II who are unable to have a defect created during debridement surgery 2. Renal failure or documented chronic kidney disease with serum creatinine ≥3.5 mg/dL (309umol/L) or being treated with dialysis 3. 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 4. Uncontrolled diabetes mellitus (hemoglobin A1c levels \>10%) 5. Pre-existing calcium metabolism disorder 6. Women who are pregnant or breastfeeding or planning on becoming pregnant during the study (a pregnancy test will be done in women of childbearing potential at screening and on the day of surgery) 7. History of hypersensitivity or contraindication to the investigational device or any of its ingredients (calcium phosphate, β-tricalcium phosphate, and aminoglycoside antibiotics) 8. Participation in an investigational drug/device study (within the last 60 days) or prior enrolment to the ADOPT GG study 9. Clinically significant or unstable medical or surgical condition that in the investigators opinion may preclude safe and complete study participation (for example patients medically unfit for surgery, general anesthesia, or any risk of significant blood loss resulting in significant risk to loss of life) 10. Current untreated malignant neoplasm(s), or current treatment with radiation therapy or chemotherapy 11. Current or recent history (within last 2 years) of active substance abuse (e.g. recreational drugs, narcotics, or alcohol) that meets DSM-5 severe criteria 12. Current user of any products containing nicotine 13. Currently incarcerated
Where this trial is running
Indianapolis, Indiana
- OrthoIndy — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Keira Watts, PHD
- Email: clinicaltrials@biocomposites.com
- Phone: +44 (0)1782 338580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.