A Multi-center Study Evaluating Genex G, an Antibiotic Bone Void Filler, for Surgical Treatment of Osteomyelitis in the Extremities

What this Trial Is About

This trial investigates the use of genex with gentamicin genex G, an antibiotic-loaded bone void filler, as part of the surgical treatment for osteomyelitis in the extremities. It is a multi-center, single-arm pivotal device study focusing on patients diagnosed with osteomyelitis classified by the Cierny-Mader system grades I-IV. The goal is to evaluate the safety and effectiveness of genex G in supporting bone healing and treating the infection. Participants will undergo surgical debridement followed by implantation of genex with gentamicin into the bone void as part of their treatment. They will also receive antibiotics according to clinical needs determined by their treatment site. The study involves a single treatment group where all participants receive genex G during surgery, and they will be monitored for 24 months after treatment to assess outcomes. During the study, participants will have regular follow-up visits to monitor infection resolution, bone healing, and any adverse events. Assessments include clinical evaluations, radiographic imaging, and quality of life questionnaires over a 24-month period. Researchers will measure the need for additional antibiotics or surgery, recurrence of infection signs, bone healing progress, and safety related to the device. The total participation time extends up to 24 months after surgery.

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