Orthopedic DisorderNCT04244942
CERAMENT™| Bone Void Filler Device Registry
An observational study of Orthopedic Disorder, run by BONESUPPORT AB at 13 sites in United States.
Trial summary
A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- CERAMENT BVF
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 13 sitesUnited States
- Study dates
- 30 Mar 2020to 30 Mar 2028
- How long will I take part?
- 18 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 received CERAMENT BVF for the treatment of their condition at the designated investigative centers. 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 BVF as a component of their treatment at a participating, contracted center 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
Who cannot join
- Any exclusion criteria as per IFU for CERAMENT BVF
- Any off-label use
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 11 recruiting
- Recruiting
Golden Orthopedic Knee, Hip, Shoulder and Foot Center
Boca Raton, Florida, 33434
Curtis Kephart, MD, drkephart@goldenortho.com
Curtis Kephart, MD
- Recruiting
Sports and Orthopedic Center
Boca Raton, Florida, 33434
Danahe Navarrete, 19543023120, dnavarrete@advancedresearchfl.com
Manish Gupta, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Santiago Lozano-Calderon, MD, PhD
Santiago Lozano-Calderon, MD, PhD
- Recruiting
OrthoCarolina
Charlotte, North Carolina, 28207
Justin Norwood, 704-323-2267, justin.norwood@orthocarolina.com
Carroll P Jones, M.D.
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Elika Fanaeian, elika.fanaeian@uhhospitals.org
George Ochenjele, MD
- Terminated
Indiana University
Indianapolis, Indiana, 46202
- Completed
OrthoIndy
Indianapolis, Indiana, 46278
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Stephen Duncan, MD, stdunc2@uky.edu
Stephen Duncan, MD
- Recruiting
Dr. Peter Merkle
Pompano Beach, Florida, 33064
Stephanie Tagland, stagland02@comcast.net
Peter Merkle, MD
- Recruiting
Florida Orthopedic Foot & Ankle Center
Sarasota, Florida, 34233
James Cottom, MD, 19419248777, jamescottom300@hotmail.com
James Cottom, MD
- Recruiting
James Cottom
Sarasota, Florida, 34233
James Cottom, 19419248777, jamescottom300@hotmail.com
James Cottom, DPM
- Recruiting
HonorHealth
Scottsdale, Arizona, 85258
Judd Cummings, MD, 16022588500, jcummings@oso.md
Judd Cummings, MD
- Recruiting
The Research Foundation of The State University of New York
Syracuse, New York, 13210
Kayla Sweeney, 3154648618, sweenkay@upstate.edu
Timothy Damron, MD
About this study
A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.
Read the detailed description
A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.
- Conditions
- Orthopedic Disorder
- Being tested
- CERAMENT BVF
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CERAMENT BVFDevice
CERAMENT BONE VOID FILLER is a synthetic biphasic bone graft substitute.
What is being measured
The primary outcome is the main question the study is designed to answer.
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Measured: 12 months
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Measured: 18 months
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Measured: 12 months
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Measured: 18 months
Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Measured: 12 and 18 months
Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Measured: 12 months
adverse device events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Adverse device events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Measured: 18 months
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Measured: 12 months
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Measured: 18 months
Secondary outcomes (4)
Radiological assessment at 6 and 12 months. Objective assessment of regeneration
Bone healing
Measured: 6 Months
Radiological assessment at 6 and 12 months. Objective assessment of regeneration
Bone healing
Measured: 12 Months
Pain VAS score
Pain assessment at 6,12, and 18 months
Measured: 6, 12, and 18 Months
EQ-5D-3L
Functional assessment at 6, 12, and 18 months
Measured: 6, 12, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start30 Mar 2020
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies 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
- 300 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- BONESUPPORT AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244942
- Sponsor's protocol ID
- S025/2018
- Status last verified
- Sep 2025
- First submitted
- 15 Jan 2020
- Last updated
- 29 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 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CERAMENT™| Bone Void Filler Device Registry
- ClinicalTrials.gov ID
- NCT04244942
- Acronym / sponsor ID
- S025/2018
- Conditions
- Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- BONESUPPORT ABIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 28 Jan 2020 (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.
A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.
Detailed description
A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 18 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 received CERAMENT BVF for the treatment of their condition at the designated investigative centers. 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 BVF as a component of their treatment at a participating, contracted center 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
Key exclusion criteria (2 listed)
- Any exclusion criteria as per IFU for CERAMENT BVF
- 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 BVFCERAMENT BONE VOID FILLER is a synthetic biphasic bone graft substitute. | Device | – |
Primary outcome
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Time frame: 12 months
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Time frame: 18 months
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Time frame: 12 months
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Time frame: 18 months
Complaints will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Time frame: 12 and 18 months
Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Time frame: 12 months
Adverse events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
adverse device events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Time frame: 18 months
Adverse device events will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Time frame: 12 months
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
Time frame: 18 months
SAEs will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months
4 secondary outcomes
Radiological assessment at 6 and 12 months. Objective assessment of regeneration
Time frame: 6 Months
Radiological assessment at 6 and 12 months. Objective assessment of regeneration
Time frame: 12 Months
Pain VAS score
Time frame: 6, 12, and 18 Months
EQ-5D-3L
Time frame: 6, 12, and 18 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 29 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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by BONESUPPORT AB at 13 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 29 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 13 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 (6178923927, brian.bartholdi@bonesupport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unexpected device performance will be collected as they occur at time of surgery and on an ongoing basis thereafter, with formal scheduled review at 12 and 18 months (time frame: 12 months). The study lists 9 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 29 Sep 2025.