Genex with gentamicin for treating osteomyelitis of the arms and legs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm, historically controlled pivotal device study in which all participants with extremity osteomyelitis undergo surgical debridement and receive Genex with gentamicin as the bone void filler. Participants will also receive systemic antibiotics as clinically indicated per site-specific practice. The study enrolls adults with Cierny-Mader grade I–IV osteomyelitis (with a requirement to create a defect for grades I–II) and requires adequate soft tissue coverage after surgery. All participants are followed for 24 months to monitor safety and infection outcomes compared against historical controls.

Why it matters

Who can join: the full rules

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
5. 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:

1. Patients diagnosed with acute osteomyelitis
2. Patients with Cierny-Mader grades I-II who are unable to have a defect created during debridement surgery
3. Renal failure or documented chronic kidney disease with serum creatinine ≥3.5 mg/dL (309umol/L) or being treated with dialysis
4. 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
5. Uncontrolled diabetes mellitus (hemoglobin A1c levels \>10%)
6. Pre-existing calcium metabolism disorder
7. 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)
8. History of hypersensitivity or contraindication to the investigational device or any of its ingredients (calcium phosphate, β-tricalcium phosphate, and aminoglycoside antibiotics)
9. Participation in an investigational drug/device study (within the last 60 days) or prior enrolment to the ADOPT GG study
10. 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)
11. Current untreated malignant neoplasm(s), or current treatment with radiation therapy or chemotherapy
12. 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
13. Currently incarcerated

Where it's running

• OrthoIndy
  Indianapolis, Indiana, United States Recruiting
• Sinai Hospital Baltimore
  Baltimore, Maryland, United States Recruiting
• Curalta Clinical Trials
  Oradell, New Jersey, United States Recruiting
• North Park Podiatry
  San Diego, California, United States Not yet recruiting

Study contacts

• Study coordinator: Keira Watts, PHD
• Email: clinicaltrials@biocomposites.com
• Phone: +44 (0)1782 338580

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Population pharmacokinetics of rifampicin in staphylococcal osteoarticular infections

  This study tests how rifampicin behaves in the body of adults with staphylococcal osteoarticular infections when given with levofloxacin or ciprofloxacin, to see how drug exposure relates to tolerance and outcomes.

  Recruiting Groupe Hospitalier Diaconesses Croix Saint-Simon · Paris, Paris · NCT07788404

• Cerament G in partial calcanectomy for heel bone infection

  This trial tests whether adding Cerament G to partial calcanectomy helps heal wounds and lower reinfection in adults with calcaneal osteomyelitis.

  Recruiting Royal College of Surgeons, Ireland · Galway · NCT07057817

• Single antibiotic versus two antibiotics for Pseudomonas bone infection

  This study will test whether one antibiotic works as well as two for adults with bone infections caused by Pseudomonas aeruginosa.

  Recruiting Centre Hospitalier de Saint-Denis · Saint-Denis, France · NCT07056881

• Using CERAMENT G during single-stage surgery to treat chronic osteomyelitis

  This test uses CERAMENT G to fill bone defects during a single-stage operation for people with chronic, severe osteomyelitis to help bone heal and lower the risk of reinfection.

  Recruiting Bonesupport Ab · Oxford · NCT06555848

• Comparing STIMULAN VG to standard care for treating severe pressure ulcers with infection

  This study is testing if a new treatment called STIMULAN VG, used with surgery and antibiotics, can help adults with severe pressure ulcers and infections heal better than standard care alone.

  Recruiting at 9 sites Phase 2 Biocomposites Ltd · Phoenix, Arizona and 8 other locations · NCT06283979

• Surgical and antibiotic treatment for pressure ulcers linked to osteomyelitis

  This study is testing if a combined surgery and antibiotic treatment can help people with neuromotor disabilities who have pressure ulcers linked to bone infections heal better.

  Recruiting Institut de Sante Parasport Connecte Synergies · Garches · NCT05713149

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.