OsteomyelitisCERTITUDENCT06555848
CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
An observational study of Osteomyelitis, run by BONESUPPORT AB at 1 site in United Kingdom.
Trial summary
The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis
- What is being tested?
- CERAMENT G
- Type of treatment
- Medical device
- How many people
- 128 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jun 2025to Oct 2032
- 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: Patients enrolled post-operatively with Osteomyelitis
Who may be able to join
- Subjects meeting the following inclusion criteria are to be included in the analysis:
- Patients receiving CERAMENT G subsequent to surgical excision of osteomyelitis, with Cierny-Mader classification grades III or IV, who require dead-space management of a bone defect following surgical debridement and excision of infection.
- Symptoms for a minimum of six months with clinical and radiological features accompanied by at least one of the following:
- the presence of a sinus
- the presence of an abscess or intra-operative pus
- the presence of positive supportive histology
- two or more microbiological cultures with indistinguishable organisms (defined as cultures resulting in identification of the same microbe (e.g., Staph aureus) with similar antimicrobial sensitivity) Notes: In cases where cultures are negative, a patient will be included in the study only if there is positive supportive histology combined with the presence of a draining sinus or intra-operative pus. Infected non-unions will be included only if the bone loss is < 1cm after debridement and excision of bone has been performed.
Who cannot join
- The subject will be excluded from the study if:
- Skeletal immaturity, defined as pre-operative/ screening radiology with evidence of incompletely fused physes. (determined by their previous x-rays which are taken as part of their admission, unrelated to the study)
- Those unable to give informed consent for inclusion in the trial, or those not willing to be included
- A known allergy or reaction to gentamicin or calcium sulfate
- Treatment with a combination of different antibiotic-eluting bone graft substitutes
- They have a segmental bone defect > 1cm
- Infection of the spine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHS
Oxford, OX37HE
Jamie Ferguson, MD, +447482491449, jamie.ferguson@ouh.nhs.uk
Jamie Ferguson, MD
About this study
Official title: A Post-Market Prospective Cohort Study on Subjects Receiving CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.
Read the detailed description
The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.
The purpose of this post market prospective cohort study is to obtain longer-term clinical and radiographic data on the safety and effectiveness of CERAMENT G as part of the surgical treatment of Osteomyelitis in a single-stage procedure.
Detailed questions to be answered are:
- What is the nature, severity, and frequency of incomplete new bone formation?
- What is the nature, severity, and frequency of the risks of probable adverse events and serious adverse events associated with incomplete new bone formation, including pathologic fractures and reinfection?
- Conditions
- Osteomyelitis
- Being tested
- CERAMENT G
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CERAMENT GDevice
CERAMENT G is intended for use as a bone void filler as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) as part of the surgical treatment of osteomyelitis. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing.
| Study group | Role | What they receive |
|---|---|---|
| CERAMENT G | Subjects receiving CERAMENT G as part of the surgical treatment of Osteomyelitis Receives: Device: CERAMENT G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint
Overall subject success requires all four of the following at 36 months post-op:
- absence of a reinfection of the original site of osteomyelitis;
- absence of purulent drainage and wound dehiscence/breakdown
- absence of a secondary surgical intervention, e.g., grafting or removal of residual CERAMENT G at the original site; and,
- a lack of serious adverse events associated with incomplete new bone formation, including pathologic fracture of the treated limb
Measured: 36 months
Co-Primary Endpoint
A trend showing increasing new bone formation and decreasing CERAMENT G as determined by a comparison of baseline and interim post-operative timepoint radiographic evaluations out to 36 months post-operative
Measured: 36 months
Secondary outcomes (2)
Radiographic Succcess
Radiographic success at 36 months, defined as CERAMENT G resorption and new bone formation (a minimum of mean void-filling of 74% in the subject population) as determined by comparison of the immediate post-op radiographs to those at 36 months
Measured: 36 months
Clinical Success
Clinical success at 36 months, defined as:
Maintenance or improvement in function (i.e., no decrease of PRO(s) in the SF-12 score between post-operative and 36 months follow-up)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start2 Jun 2025
- Primary completionOct 2031 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BONESUPPORT AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555848
- Sponsor's protocol ID
- 339381
- Acronym
- CERTITUDE
- Status last verified
- Apr 2026
- First submitted
- 13 Aug 2024
- Last updated
- 4 May 2026
- 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 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Prospective Cohort Study on Subjects Receiving CERAMENT G as Part of the Surgical Treatment of Osteomyelitis in a Single-Stage Procedure
- ClinicalTrials.gov ID
- NCT06555848
- Acronym / sponsor ID
- CERTITUDE / 339381
- Conditions
- Osteomyelitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- BONESUPPORT ABIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 15 Aug 2024 (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.
The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.
Detailed description
The study is a prospective cohort study of subjects where CERAMENT G was used as part of the surgical treatment of osteomyelitis in a single stage procedure.
The purpose of this post market prospective cohort study is to obtain longer-term clinical and radiographic data on the safety and effectiveness of CERAMENT G as part of the surgical treatment of Osteomyelitis in a single-stage procedure.
Detailed questions to be answered are:
- What is the nature, severity, and frequency of incomplete new bone formation?
- What is the nature, severity, and frequency of the risks of probable adverse events and serious adverse events associated with incomplete new bone formation, including pathologic fractures and reinfection?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CERAMENT G | – | Device: CERAMENT GSubjects receiving CERAMENT G as part of the surgical treatment of Osteomyelitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled post-operatively with Osteomyelitis
Key inclusion criteria (7 listed)
- Patients receiving CERAMENT G subsequent to surgical excision of osteomyelitis, with Cierny-Mader classification grades III or IV, who require dead-space management of a bone defect following surgical debridement and excision of infection.
- Symptoms for a minimum of six months with clinical and radiological features accompanied by at least one of the following:
Key exclusion criteria (7 listed)
- Skeletal immaturity, defined as pre-operative/ screening radiology with evidence of incompletely fused physes. (determined by their previous x-rays which are taken as part of their admission, unrelated to the study)
- Those unable to give informed consent for inclusion in the trial, or those not willing to be included
- A known allergy or reaction to gentamicin or calcium sulfate
- Treatment with a combination of different antibiotic-eluting bone graft substitutes
- They have a segmental bone defect > 1cm
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 GCERAMENT G is intended for use as a bone void filler as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) as part of the surgical treatment of osteomyelitis. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing. | Device | CERAMENT G |
Primary outcome
Composite Endpoint
Time frame: 36 months
Overall subject success requires all four of the following at 36 months post-op: * absence of a reinfection of the original site of osteomyelitis; * absence of purulent drainage and wound dehiscence/breakdown * absence of a secondary surgical intervention, e.g., grafting or removal of residual CERAMENT G at the original site; and, * a lack of serious adverse events associated with incomplete new bone formation, including pathologic fracture of the treated limb
Co-Primary Endpoint
Time frame: 36 months
A trend showing increasing new bone formation and decreasing CERAMENT G as determined by a comparison of baseline and interim post-operative timepoint radiographic evaluations out to 36 months post-operative
2 secondary outcomes
Radiographic Succcess
Time frame: 36 months
Clinical Success
Time frame: 36 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 4 May 2026.
- 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.
Bone Infection Unit, Nuffield Orthopaedic Centtre, Oxford University Hospitals, MHS
Oxford, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteomyelitis, run by BONESUPPORT AB at 1 site in United Kingdom.
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 7 inclusion and 7 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 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Endpoint (time frame: 36 months). The study lists 2 primary outcomes in all. 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 4 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.