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

Official title

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.

Overview

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.

Interventions

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

Primary outcome 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. [Time frame: Month 12]
• No further surgical interventions required due to infection at the index site. [Time frame: Month 12]
• No recurrence of sinus formation at the index site. [Time frame: Month 12]

Secondary outcome measures (12)

• No additional requirement for antibiotic treatment due to persisting symptoms of infection at the treatment site, i.e., additional antibiotics prescribed following completion of the initial systemic antibiotics prescribed post-surgery. [Time frame: Month 24]
• No radiographic evidence of post op fractures. [Time frame: Month 24]
• Radiographic evidence of new bone healing. [Time frame: Month 24]
• No recurrence of sinus formation at the treatment site. [Time frame: Month 24]
• No secondary surgical interventions (SSI's) related to the investigational treatment. [Time frame: Month 24]
• No serious adverse events that are definitely related to genex G. [Time frame: Month 24]
• Radiographic Evidence of new bone formation and product reabsorption. [Time frame: Month 24]
• Infection resolution evaluated by radiographic assessment and clinical endpoints. [Time frame: Month 24]
• Adverse events including wound problems, reaction to combination product, fracture at treatment site. [Time frame: Month 24]
• Secondary Surgical Interventions (SSI's) [Time frame: Month 24]
• Number of participants discontinuing therapy prematurely due to a device related event. [Time frame: Month 24]
• Number of hospitalisations/re-hospitalisation due to treatment site Osteomyelitis. [Time frame: Month 24]

Eligibility criteria

Inclusion criteria

• 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
• Patients at least 18 years of age \*1
• Patient willing and able to provide written informed consent
• Patient geographically stable and able to comply with the required follow-up visits and testing schedule as assessed by the investigator
• Ability to achieve adequate surgical soft tissue coverage of the wound (primary tissue closure or surgical reconstruction including local and free soft tissue transfer)

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

Exclusion criteria

• Patients diagnosed with acute osteomyelitis
• Patients with Cierny-Mader grades I-II who are unable to have a defect created during debridement surgery
• Renal failure or documented chronic kidney disease with serum creatinine ≥3.5 mg/dL (309umol/L) or being treated with dialysis
• Participants with a terminal or palliative diagnosis (e.g. terminal cancer diagnosis) deemed to have less than 1 year life expectancy by their health care team
• Uncontrolled diabetes mellitus (hemoglobin A1c levels >10%)
• Pre-existing calcium metabolism disorder
• Women who are pregnant or breastfeeding or planning on becoming pregnant during the study (a pregnancy test will be done in women of childbearing potential at screening and on the day of surgery)
• History of hypersensitivity or contraindication to the investigational device or any of its ingredients (calcium phosphate, β-tricalcium phosphate, and aminoglycoside antibiotics)
• Participation in an investigational drug/device study (within the last 60 days) or prior enrolment to the ADOPT GG study
• Clinically significant or unstable medical or surgical condition that in the investigators opinion may preclude safe and complete study participation (for example patients medically unfit for surgery, general anesthesia, or any risk of significant blood loss resulting in significant risk to loss of life)
• Current untreated malignant neoplasm(s), or current treatment with radiation therapy or chemotherapy
• Current or recent history (within last 2 years) of active substance abuse (e.g. recreational drugs, narcotics, or alcohol) that meets DSM-5 severe criteria
• Current user of any products containing nicotine
• Currently incarcerated

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 4 centers

• North Park Podiatry — San Diego
• OrthoIndy — Indianapolis
• Sinai Hospital Baltimore — Baltimore
• Curalta Clinical Trials — Oradell

Identifiers

NCT: NCT07270380 · 201924

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗