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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Biocomposites Ltd
Study ID
NCT07270380
Status
Recruiting
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Conditions

  • Osteomyelitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • genex with gentamicin (genex G) — DEVICE
    genex with gentamicin will be implanted during debridement surgery

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
139 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Participants will receive genex with Gentamicin, an antibiotic loaded bone void filler that supports bone healing, as part of the surgical treatment of osteomyelitis of the extremities.

Primary Outcome Measure

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. [ Time Frame: Month 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OrthoIndyIndianapolisIndiana46278
Kimberly Fitzpatrick
[email protected]
Melanie Glover
[email protected]
Sandeep Soin, MD (PRINCIPAL_INVESTIGATOR)

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By research site
OrthoIndy· Indianapolis, IN

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