Registry for the CERAMENT G device in treating bone infections
CERAMENT G Device Registry
This study is collecting information on how well the CERAMENT G device works for treating bone infections in adults over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bonesupport Ab Industry-sponsored |
| Locations | 3 sites (San Diego, California and 2 other locations) |
| Trial ID | NCT06010433 on ClinicalTrials.gov |
What this trial studies
This observational registry collects data on the use of the CERAMENT G device in patients with chronic osteomyelitis, fracture-related infections, and diabetic foot osteomyelitis. The study will run for three years, gathering real-world performance data as patients receive the device as part of their treatment. Participants must be 18 years or older and provide informed consent. The registry aims to reflect the effectiveness and safety of the device in typical clinical settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who are receiving CERAMENT G as part of their treatment for specified bone infections.
Not a fit: Patients who are not receiving CERAMENT G or those with contraindications as per the device's instructions for use may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness of CERAMENT G, potentially improving treatment outcomes for patients with bone infections.
How similar studies have performed: While this approach is observational and builds on existing device usage, similar registries have shown success in providing real-world data that informs clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years and over (on the day of surgery) * receive CERAMENT\|G as a component of their treatment at a participating, contracted centre or healthcare provider, in accordance with the IFU for the implanted product * In receipt of patient information leaflet and have signed appropriately designed informed consent form. Exclusion Criteria: * Any exclusion criteria as per IFU for CERAMENT\|G * Any off-label use
Where this trial is running
San Diego, California and 2 other locations
- North Park Podiatry — San Diego, California, United States (Recruiting)
- OrthoCarolina — Charlotte, North Carolina, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Brian M Bartholdi
- Email: brian.bartholdi@bonesupport.com
- Phone: 16178923927
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.