Chronic OsteomyelitisNCT06010433
CERAMENT G Device Registry
An observational study of Chronic Osteomyelitis and Fracture Related Infection, run by BONESUPPORT AB at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Osteomyelitis, Fracture Related Infection, Diabetic Foot Osteomyelitis
- What is being tested?
- CERAMENT G
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Aug 2023to 22 Sep 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
- Any exclusion criteria as per IFU for CERAMENT|G
- Any off-label use
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
OrthoCarolina
Charlotte, North Carolina, 28207
Zach Hutchko, MS, 704 323 2556, Zachery.Hutchko@orthocarolina.com
Samuel Ford, MD
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Alexander Nighswander, MPH, alexander.nighswander@uhhospitals.org
George Ochenjele, MD
- Recruiting
North Park Podiatry
San Diego, California, 92104
Trent Brookshier, DPM, 6172832097, trentbrookshier@gmail.com
Trent Brookshier, DPM
About this study
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.
- Being tested
- CERAMENT G
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CERAMENT GDevice
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcomes
- Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.
Measured: 12 months
Secondary outcomes (3)
Secondary Outcome
Bone healing at final follow-up
Measured: 12 months
Secondary Outcome
Pain and functional assessment at whatever follow-up times are usual for the specific clinical site, for example 6 \& 12 months, if normally conducted
Measured: 6 and 12 months
Secondary Outcome
(Recurrence of) infection/revision surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start17 Aug 2023
- Primary completion22 Sep 2028 (estimated)
- Study completion22 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic OsteomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- BONESUPPORT AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010433
- Sponsor's protocol ID
- S050/2018
- Status last verified
- Sep 2025
- First submitted
- 25 May 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CERAMENT G Device Registry
- ClinicalTrials.gov ID
- NCT06010433
- Acronym / sponsor ID
- S050/2018
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BONESUPPORT ABIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 22 Sep 2028 (estimated)
- Study completion
- 22 Sep 2028 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Any exclusion criteria as per IFU for CERAMENT|G
- Any off-label use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
Primary Outcomes
Time frame: 12 months
• Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.
3 secondary outcomes
Secondary Outcome
Time frame: 12 months
Secondary Outcome
Time frame: 6 and 12 months
Secondary Outcome
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Osteomyelitis and Fracture Related Infection, run by BONESUPPORT AB at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian M Bartholdi (16178923927, brian.bartholdi@bonesupport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcomes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.