Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin. (ADOPT GG)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Osteomyelitis
• Intervention / Treatment: Device: genex with gentamicin (genex G)

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.

• Study Type: Interventional
• Enrollment (Estimated): 139
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Keira Watts, PHD; Phone Number: +44 (0)1782 338580; Email: clinicaltrials@biocomposites.com
• Study Contact Backup: Name: Simal Trikam; Email: strikam@mcra.com

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46278
      • Recruiting
      • OrthoIndy
      • Contact: Melanie Glover; Email: mglover@orthoindy.com
      • Contact: Kimberly Fitzpatrick; Email: kifitzpatrick@orthoindy.com
      • Principal Investigator: Sandeep Soin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; 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); genex with gentamicin will be implanted during debridement surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Further requirement for antibiotic treatment due to persisting symptoms of infection at the site of treatment will be assessed at Month 24.	Month 24
No radiographic evidence of post op fractures.	Radiographic evidence of post-operative fractures will be evidenced by X-ray & CT evaluations and assessed at Month 24.	Month 24
Radiographic evidence of new bone healing.	Radiographic evidence of new bone healing will be evidenced by X-ray and CT evaluations and assessed at Month 24.	Month 24
No recurrence of sinus formation at the treatment site.	Recurrence of sinus formation at the index site will be assessed by contrast enhanced CT evaluation and Clinical endpoint assessments measured at Month 24.	Month 24
No secondary surgical interventions (SSI's) related to the investigational treatment.	Secondary Surgical interventions (SSI's) related to the investigational treatment will be assessed at Month 24.	Month 24
No serious adverse events that are definitely related to genex G.	Serious adverse events that are definitely related to genex G will be assessed at Month 24.	Month 24
Radiographic Evidence of new bone formation and product reabsorption.	Radiographic evidence of new bone formation and product reabsorption will be evidenced by X-ray and CT evaluations during the course of the trial and recorded on the participants electronic case report form (eCRF).	Month 24
Infection resolution evaluated by radiographic assessment and clinical endpoints.	Radiographic evidence of infection resolution will be evidenced by contrast enhanced CT evaluations and clinical endpoint assessments assessed during the course of the trial and recorded on the participants electronic case report form (eCRF).	Month 24
Adverse events including wound problems, reaction to combination product, fracture at treatment site.	Adverse events including wound problems, reaction to combination product, fracture at treatment site will be assessed during the course of the trial and recorded on the participants electronic case report form (eCRF).	Month 24
Secondary Surgical Interventions (SSI's)	Number of Secondary Surgical Interventions (SSI's) will be assessed during the course of the trial and recorded on the participants electronic case report form (eCRF).	Month 24
Number of participants discontinuing therapy prematurely due to a device related event.	Number of participants discontinuing therapy prematurely due to a device related event will be assessed during the course of the trial and recorded on the participants electronic case report form (eCRF).	Month 24
Number of hospitalisations/re-hospitalisation due to treatment site Osteomyelitis.	Number of hospitalisations/re-hospitalisation due to treatment site Osteomyelitis.	Month 24
Quality of Life EQ-5D-5L	Impact on the participants Quality of Life will be measured by the EQ-5D-5L during the course of the trial and recorded on the participants electronic case report form (eCRF).	Month 24

Collaborators and Investigators

• Sponsor: Biocomposites Ltd
• Investigators: Study Director: Keira Watts, PHD, Biocomposites Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Gentamicin; Single Arm; Bone Void Filler; Historical Control; Pivotal Device Study; Systemic Antibiotics; genex
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Infections; Bone Diseases, Infectious; Osteomyelitis
• Other Study ID Numbers: 201924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes