NCT07270380

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

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (estimated)
• Sponsor: Biocomposites Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This trial is a multi-center, single arm, historically controlled, pivotal device study. All participants diagnosed with osteomyelitis of the extremities (Cierny-Mader Classification grades I-IV) can be considered. All participants will undergo surgical debridement and will receive genex with gentamicin (genex G) antibiotic loaded bone void filler as part of the surgical treatment of osteomyelitis of the extremities. Participants will receive antibiotics per site specific requirements as clinically indicated. All participants will be followed up for 24 Months.

Conditions

• Osteomyelitis

Interventions

Type	Name	Description
DEVICE	genex with gentamicin (genex G)	genex with gentamicin will be implanted during debridement surgery

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-10-01
• Completion: 2028-10-01
• First posted: 2025-12-08
• Last updated: 2026-04-02

Regulatory

• FDA-regulated device study