New registry to monitor Real-World use of bone infection device
NCT ID NCT06010433
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is a registry that collects information from 100 adults with chronic bone infections who receive CERAMENT G as part of their normal care. The goal is to see how safe and effective the device is in real-world settings by tracking complications, bone healing, pain, and infection recurrence. No extra treatments or tests are given beyond standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The racial, gender and ethnic characteristics of the individuals approached for participation in this Observational Registry Study shall reflect the demographics of patients that would ordinarily receive CERAMENT\|G for the treatment of their condition at the designated investigative centres. No individuals shall be excluded from participation in the Observational Registry Study based on race, nationality, ethnicity, gender, or sexuality
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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North Park Podiatry
RECRUITINGSan Diego, California, 92104, United States
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OrthoCarolina
RECRUITINGCharlotte, North Carolina, 28207, United States
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University Hospitals Cleveland Medical Center
RECRUITINGCleveland, Ohio, 44106, United States
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