CERAMENT G Device Registry
1 other identifier
observational
100
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2023
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2023
CompletedStudy Start
First participant enrolled
August 17, 2023
CompletedFirst Posted
Study publicly available on registry
August 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 22, 2028
September 26, 2025
September 1, 2025
5.1 years
May 25, 2023
September 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Outcomes
• Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.
12 months
Secondary Outcomes (3)
Secondary Outcome
12 months
Secondary Outcome
6 and 12 months
Secondary Outcome
12 months
Interventions
* 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.
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- Any off-label use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BONESUPPORT ABlead
Study Sites (3)
North Park Podiatry
San Diego, California, 92104, United States
OrthoCarolina
Charlotte, North Carolina, 28207, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2023
First Posted
August 24, 2023
Study Start
August 17, 2023
Primary Completion (Estimated)
September 22, 2028
Study Completion (Estimated)
September 22, 2028
Last Updated
September 26, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share