139 Participants NeededMy employer runs this trial

Genex with Gentamicin for Osteomyelitis

(ADOPT GG Trial)

Recruiting at 3 trial locations
ST
KW
Overseen ByKeira Watts, PHD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a bone filler called Genex with Gentamicin can safely and effectively treat osteomyelitis, a serious bone infection, during surgery. The trial will use this antibiotic-loaded filler to aid bone healing in the arms or legs. It seeks individuals who have had osteomyelitis in their limbs for at least six months and require surgery. Participants must attend follow-up visits and have wounds that can be properly closed after surgery. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment approach.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that Genex with Gentamicin is safe for treating osteomyelitis in the extremities?

Research has shown that using Genex with gentamicin is generally safe for treating bone infections like osteomyelitis. In one study, 94% of patients did not experience a recurrence of their infection after treatment, with only a few facing a return within the first year. Another report found that this treatment improves patients' quality of life. However, some patients did experience the infection returning weeks to months after treatment. Overall, Genex with gentamicin appears to be a safe option, but there remains a risk of infection recurrence.12345

Why are researchers excited about this trial?

Researchers are excited about Genex with Gentamicin for osteomyelitis because it combines a bone void filler with an antibiotic, Gentamicin, directly at the site of infection. This dual-action approach not only supports bone healing but also delivers the antibiotic right where it's needed, potentially improving outcomes. Unlike traditional treatments that might rely solely on systemic antibiotics and surgical interventions, this method targets the infection locally, which could enhance effectiveness and reduce recovery time.

What evidence suggests that Genex with Gentamicin might be an effective treatment for osteomyelitis?

Research has shown that genex with gentamicin, a special bone filler containing antibiotics, holds promise for treating osteomyelitis, a bone infection. Studies have found that treatments like genex and other antibiotic carriers effectively reduce infections. For example, one study reported that 94% of patients were free from infection after treatment. Another study demonstrated that these treatments can deliver antibiotics directly to the infected area in the bone. These findings suggest that genex with gentamicin could be a good option for treating osteomyelitis in the arms and legs. Participants in this trial will receive genex with gentamicin as part of their surgical treatment.13467

Who Is on the Research Team?

KW

Keira Watts, PHD

Principal Investigator

Biocomposites Ltd

Are You a Good Fit for This Trial?

This trial is for adults (18+) with a long-term bone infection in their arms or legs that needs surgery. Participants must be able to give consent, attend follow-up visits, and have wounds that can be properly closed after surgery. Young adults (18-22) need proof their bones are fully grown.

Inclusion Criteria

Patient willing and able to provide written informed consent
I am at least 18 years old.
Patient geographically stable and able to comply with the required follow-up visits and testing schedule as assessed by the investigator
See 2 more

Exclusion Criteria

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
Current user of any products containing nicotine
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Treatment

Participants undergo surgical debridement and receive genex with gentamicin as part of the treatment for osteomyelitis

1 week
1 visit (in-person)

Post-Surgical Antibiotic Treatment

Participants receive antibiotics per site-specific requirements as clinically indicated

12 weeks

Follow-up

Participants are monitored for safety and effectiveness, including assessments for infection resolution and bone healing

24 months
Regular follow-up visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Genex With Gentamicin

Trial Overview

The study is testing genex G, a special filler placed into the bone during surgery that slowly releases an antibiotic called gentamicin. The goal is to see if this device safely helps treat bone infections in the limbs.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Biocomposites Ltd

Lead Sponsor

Trials
6
Recruited
270+

Citations

Antibiotic Device for Osteomyelitis of the Extremities Pivotal ...

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 ...

Biocomposites Present Data on STIMULAN® & genex® at ...

Research findings from two studies demonstrate the antimicrobial effectiveness of STIMULAN® and genex®, when mixed with antibiotics.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36047024/

Mid- to long-term results of single-stage surgery for patients ...

Results: At final follow-up, six patients (six bones) had recurrent infection; thus 94% were infection-free. Three infections recurred in the first year, two in ...

Biocomposites to present data on STIMULAN® and genex ...

STIMULAN® and genex® present similar levels and durations of in vitro antimicrobial activity against pathogens common to orthopaedic infection, and ...

Cost-effectiveness of a bone substitute delivering gentamicin ...

The effectiveness of these antibiotics relies on their ability to penetrate bone tissue. Despite the progress made in both antibiotics and ...

Antibiotic Device for Osteomyelitis of the Extremities Pivotal ...

Study Goals. To determine if Genex with gentamicin (an antibiotic-loaded bone void filler) is effective and safe for treating bone infections (osteomyelitis) ...

Clinical use and safety of a novel gentamicin-releasing ... - PMC

A clinical investigation into a new bone void filler is giving first data on systemic and local exposure to the anti-infective substance ...