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.
Biocomposites Ltd
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient with osteomyelitis of the extremities, who have failed antibiotic therapy and are requiring surgical intervention (unresolved osteomyelitis), 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…
Interventions
- Devicegenex with gentamicin (genex G)
genex with gentamicin will be implanted during debridement surgery
Location
- OrthoIndyIndianapolis, Indiana