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

NCT07270380 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 201924
• Study Type: interventional
• Target: 139
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteomyelitis

Keywords

Single Arm; Historical Control; Pivotal Device Study; Bone Void Filler; Gentamicin; Systemic Antibiotics; genex

Outcome Measures

Primary Outcomes (3)

• 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.

  Further requirement for antibiotic treatment due to persisting symptoms of infection at the site of treatment will be assessed at Month 12.

  Month 12

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

  Need for further surgical interventions required due to infection at the index site will be assessed at Month 12.

  Month 12

• No recurrence of sinus formation at the index site.

  Recurrence of sinus formation at the index site will be assessed by a non-contrast CT scan at week 2 \& Month 12. Clinical endpoint assessments will also be used to measure this at post operative follow-up visits and will be assessed at Month 12.

  Month 12

Secondary Outcomes (13)

• 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.

  Month 24

• No radiographic evidence of post op fractures.

  Month 24

• Radiographic evidence of new bone healing.

  Month 24

• No recurrence of sinus formation at the treatment site.

  Month 24

• No secondary surgical interventions (SSI's) related to the investigational treatment.

  Month 24

Study Arms (1)

Single Arm

EXPERIMENTAL

Participants will receive genex with Gentamicin, an antibiotic loaded bone void filler that supports bone healing, as part of the surgical treatment of osteomyelitis of the extremities.

Device: genex with gentamicin (genex G)

Interventions

genex with gentamicin (genex G) DEVICE

genex with gentamicin will be implanted during debridement surgery

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biocomposites Ltd: lead

MeSH Terms

Conditions

Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Keira Watts, PHD

  Biocomposites Ltd

  STUDY DIRECTOR

Central Study Contacts

Keira Watts, PHD

CONTACT

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

Simal Trikam

CONTACT

strikam@mcra.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 8, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share