Registry for the CERAMENT G device in treating bone infections
Official title: CERAMENT G Device Registry
Run by Bonesupport Ab · NCT06010433 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Bonesupport Ab Industry-sponsored |
| Locations | 3 sites (San Diego, California and 2 other locations) |
| Status | Recruiting |
| Started | August 17, 2023 |
| Main results expected | September 22, 2028 |
| Study ends | September 22, 2028 |
| Registry record updated | September 26, 2025 |
| Trial ID | NCT06010433 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and over who are receiving CERAMENT G as part of their treatment for specified bone infections.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using CERAMENT G during single-stage surgery to treat chronic osteomyelitis
This test uses CERAMENT G to fill bone defects during a single-stage operation for people with chronic, severe osteomyelitis to help bone heal and lower the risk of reinfection.
-
Registry for the performance of a bone void filler device
This study is collecting information on how well the CERAMENT Bone Void Filler works for patients over 18 who are getting orthopedic procedures to help improve its use in the future.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.