CERAMENT G Device Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CERAMENT G.
- Who it may be relevant to
- Registry conditions: Chronic Osteomyelitis, Fracture Related Infection, Diabetic Foot Osteomyelitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This is an Observational Device Registry Study of CERAMENT\|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance.
Interventions
- Device CERAMENT G
* Primary mode of action is to be a resorbable ceramic bone graft substitute intended to fill gaps and voids in the skeleton system to promote bone healing. CERAMENT ™\|G provides a void/gap filler that during the surgical procedure can augment hardware and bone alignments. * Secondary mode of action is to prevent colonization of Gentamicin sensitive microorganisms in order to protect bone healing.
Primary outcome measures
- Primary Outcomes [Time frame: 12 months]
Secondary outcome measures (3)
- Secondary Outcome [Time frame: 12 months]
- Secondary Outcome [Time frame: 6 and 12 months]
- Secondary Outcome [Time frame: 12 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 3 centers
- North Park Podiatry — San Diego
- OrthoCarolina — Charlotte
- University Hospitals Cleveland Medical Center — Cleveland
Identifiers
NCT: NCT06010433 · S050/2018