Registry for the performance of a bone void filler device
Official title: CERAMENT™| Bone Void Filler Device Registry
Run by Bonesupport Ab · NCT04244942 · Data updated 2026-11-12
This study is collecting information on how well the CERAMENT Bone Void Filler works for patients over 18 who are getting orthopedic procedures to help improve its use in the future.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Bonesupport Ab Industry-sponsored |
| Locations | 13 sites (Scottsdale, Arizona and 12 other locations) |
| Status | Recruiting |
| Started | March 30, 2020 |
| Main results expected | March 30, 2028 |
| Study ends | March 30, 2028 |
| Registry record updated | September 29, 2025 |
| Trial ID | NCT04244942 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and over who are scheduled to receive the CERAMENT BVF as part of their orthopedic treatment.
✕Probably not a fit
Patients who are not receiving the CERAMENT BVF or those with contraindications as per the device's instructions for use may not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry collects data on the performance of the CERAMENT Bone Void Filler (BVF) during its normal use in patients undergoing orthopedic procedures. Participants aged 18 and older who receive the CERAMENT BVF as part of their treatment at designated healthcare centers will be included in the registry. The aim is to gather real-world evidence on the effectiveness and safety of the device in clinical practice. Data collected will help inform future use and potential improvements of the product.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of the CERAMENT BVF's effectiveness, leading to improved treatment outcomes for patients with orthopedic disorders.
How similar studies have gone: While this registry approach is common in device evaluation, the specific use of CERAMENT BVF in this manner is part of ongoing efforts to gather real-world data, indicating a blend of established methodology with a focus on a specific product.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Any exclusion criteria as per IFU for CERAMENT BVF * Any off-label use
Where it's running
-
HonorHealth
Scottsdale, Arizona, United States Recruiting -
Golden Orthopedic Knee, Hip, Shoulder and Foot Center
Boca Raton, Florida, United States Recruiting -
Sports and Orthopedic Center
Boca Raton, Florida, United States Recruiting -
Dr. Peter Merkle
Pompano Beach, Florida, United States Recruiting -
Florida Orthopedic Foot & Ankle Center
Sarasota, Florida, United States Recruiting -
James Cottom
Sarasota, Florida, United States Recruiting
Show 7 more locations
-
University of Kentucky
Lexington, Kentucky, United States Recruiting -
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
The Research Foundation of The State University of New York
Syracuse, New York, United States Recruiting -
OrthoCarolina
Charlotte, North Carolina, United States Recruiting -
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States Recruiting -
Indiana University
Indianapolis, Indiana, United States Terminated -
OrthoIndy
Indianapolis, Indiana, United States Completed
Study contacts
- Study coordinator: Brian M Bartholdi
- Email: brian.bartholdi@bonesupport.com
- Phone: 6178923927
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Constipation Prevention Checklist in hip surgery patients
A simple checklist is used to see if hip surgery patients can stay regular by staying hydrated, eating well, moving early, and using abdominal massage.
-
Clinical and radiological follow-up after total ankle replacement
This study will see how people with ankle osteoarthritis do after getting a total ankle replacement by tracking their symptoms and X‑rays over time.
-
Web-based mind-body program to build resilience for adults with non‑traumatic upper‑extremity pain and risky substance use
This trial will try an online mind‑body program to help adults with non‑traumatic upper‑extremity pain who also engage in risky substance use build resilience and better cope with pain and substance urges.
-
Podcast to prevent constipation before and after orthopedic surgery
This study is testing whether a podcast that shares tips about preventing constipation can help patients having orthopedic surgery avoid this problem before and after their operations.
-
Comparing early and delayed rehabilitation after shoulder surgery for fractures
This study is testing whether starting physical therapy two weeks or six weeks after shoulder surgery helps patients recover better from their fractures.
-
Preventing incision infections in orthopedic surgery through integrated medical teams
This study tests if having a team of doctors and nurses work closely together in the operating room can help prevent infections after orthopedic surgeries.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.