Not Yet RecruitingNot Applicable

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

139 participantsStarted 2026-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patient with osteomyelitis of the extremities (for a minimum of 6 months) that requires surgical intervention (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)

Exclusion criteria

✕. 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

What they're measuring

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.

Timeframe: Month 12

No further surgical interventions required due to infection at the index site.

Timeframe: Month 12

No recurrence of sinus formation at the index site.

Timeframe: Month 12

Trial details

NCT IDNCT07270380

SponsorBiocomposites Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Keira Watts, PHD

+44 (0)1782 338580 clinicaltrials@biocomposites.com

View on ClinicalTrials.gov More Osteomyelitis trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patient with osteomyelitis of the extremities (for a minimum of 6 months) that requires surgical intervention (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)

Exclusion criteria

✕. 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

What they're measuring

Timeframe: Month 12

No further surgical interventions required due to infection at the index site.

Timeframe: Month 12

No recurrence of sinus formation at the index site.

Timeframe: Month 12