OsteomyelitisADOPT GGNCT07270380
Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.
A study testing genex with gentamicin (genex G) in people with Osteomyelitis, run by Biocomposites Ltd at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis
- What is being tested?
- genex with gentamicin (genex G)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Oct 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
- Currently incarcerated
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Simal Trikam contact
United States4 sites, 4 recruiting
- Recruiting
Sinai Hospital Baltimore
Baltimore, Maryland, 21215
Nathaniel Helwig, nhelwig@lifebridgehealth.org
Sara Orem, sorem@lifebridgehealth.org
- Recruiting
OrthoIndy
Indianapolis, Indiana, 46278
Kimberly Fitzpatrick, kifitzpatrick@orthoindy.com
Melanie Glover, mglover@orthoindy.com
- Recruiting
Curalta Clinical Trials
Oradell, New Jersey, 07649
Radhika Gajera, rgajera@curalta.com
Harrison Miller, hmiller@curalta.com
- Recruiting
North Park Podiatry
San Diego, California, 92104
Marbella Lara, marbella.npp@gmail.com
Trent Brookshier, DPM, trentbrookshier@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteomyelitis
- Being tested
- genex with gentamicin (genex G)
- Keywords
- Single Arm, Historical Control, Pivotal Device Study, Bone Void Filler, Gentamicin, Systemic Antibiotics, genex
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genex with gentamicin (genex G)Device
genex with gentamicin will be implanted during debridement surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: genex with gentamicin (genex G) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Further requirement for antibiotic treatment due to persisting symptoms of infection at the site of treatment will be assessed at Month 24.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Month 24
Number of hospitalisations/re-hospitalisation due to treatment site Osteomyelitis.
Number of hospitalisations/re-hospitalisation due to treatment site Osteomyelitis.
Measured: 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).
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start20 Oct 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocomposites Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keira Watts, PHD, Study director, Biocomposites Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270380
- Sponsor's protocol ID
- 201924
- Acronym
- ADOPT GG
- Status last verified
- Jul 2026
- First submitted
- 26 Nov 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07270380
- Acronym / sponsor ID
- ADOPT GG / 201924
- Conditions
- Osteomyelitis
- Keywords
- Single Arm, Historical Control, Pivotal Device Study, Bone Void Filler, Gentamicin, Systemic Antibiotics, genex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Biocomposites LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: genex with gentamicin (genex G)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- 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)
Key exclusion criteria (13 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genex with gentamicin (genex G)genex with gentamicin will be implanted during debridement surgery | Device | Single Arm |
Primary outcome
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.
Time frame: Month 12
Further requirement for antibiotic treatment due to persisting symptoms of infection at the site of treatment will be assessed at Month 12.
No further surgical interventions required due to infection at the index site.
Time frame: Month 12
Need for further surgical interventions required due to infection at the index site will be assessed at Month 12.
No recurrence of sinus formation at the index site.
Time frame: Month 12
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.
13 secondary outcomes
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.
Time frame: Month 24
No radiographic evidence of post op fractures.
Time frame: Month 24
Radiographic evidence of new bone healing.
Time frame: Month 24
No recurrence of sinus formation at the treatment site.
Time frame: Month 24
No secondary surgical interventions (SSI's) related to the investigational treatment.
Time frame: Month 24
No serious adverse events that are definitely related to genex G.
Time frame: Month 24
Radiographic Evidence of new bone formation and product reabsorption.
Time frame: Month 24
Infection resolution evaluated by radiographic assessment and clinical endpoints.
Time frame: Month 24
Adverse events including wound problems, reaction to combination product, fracture at treatment site.
Time frame: Month 24
Secondary Surgical Interventions (SSI's)
Time frame: Month 24
Number of participants discontinuing therapy prematurely due to a device related event.
Time frame: Month 24
Number of hospitalisations/re-hospitalisation due to treatment site Osteomyelitis.
Time frame: Month 24
Quality of Life EQ-5D-5L
Time frame: Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simal Trikam contact
Keira Watts, PHD study director
Biocomposites Ltd
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing genex with gentamicin (genex G) in people with Osteomyelitis, run by Biocomposites Ltd at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keira Watts, PHD (+44 (0)1782 338580, clinicaltrials@biocomposites.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.