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New treatment option for Osteomyelitis
Official title Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.
ClinicalTrials.gov ID: NCT07270380
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient with osteomyelitis of the extremities, who have failed antibiotic therapy and are requiring surgical intervention (unresolved osteomyelitis)...
- 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...
You likely can't join if
- 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...
- Uncontrolled diabetes mellitus (hemoglobin A1c levels \>10%)
- Pre-existing calcium metabolism disorder
See the full eligibility 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...
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.