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Genex With Gentamicin for Osteomyelitis of the Extremities

This study is testing if a device called genex with gentamicin (genex G) is a safe and effective treatment for osteomyelitis (a bone infection) in the arms or legs. Genex G is an antibiotic-loaded bone void filler that would be implanted during surgery. You might be able to join if you are at least 18 years old, have osteomyelitis in your extremities, and previous antibiotic treatment hasn't worked, requiring surgery. The study will look for success by checking if you need more antibiotics or surgery for the infection, or if the infection returns, 12 months after the initial surgery. The current recruitment status is unclear.

Study design
This is a single-arm study, meaning all participants will receive the genex with gentamicin device. It aims to enroll 139 participants.
What's involved
You would undergo surgical debridement and receive the genex with gentamicin device. You would also receive antibiotics as needed and be followed for 24 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after the initial treatment.

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NCT07270380

Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.

Recruiting
NAAges 18+InterventionalTreatment
Biocomposites Ltd
~139 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:genex with gentamicin (genex G)

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Month 12
+2 more outcomes measured

Conditions

Osteomyelitis

Explore related trials

Osteomyelitis

Where it's being run

4 sites across 4 states
California1
Indiana1
Maryland1
New Jersey1

Study leadership

  • Keira Watts, PHD · STUDY_DIRECTOR · Biocomposites Ltd

Who to contact

Keira Watts, PHD
[email protected]
+44 (0)1782 338580
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Eligibility criteria

Inclusion

1 Patients between 18 and 22 years of age require confirmation of skeletal maturity as validated by radiographs of the bone to be treated.

What this trial measures

  • 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.Month 12

    Further requirement for antibiotic treatment due to persisting symptoms of infection at the site of treatment will be assessed at Month 12.

  • No further surgical interventions required due to infection at the index site.Month 12

    Need for further surgical interventions required due to infection at the index site will be assessed at Month 12.

  • No recurrence of sinus formation at the index site.Month 12

    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.