Registry for the performance of a bone void filler device
CERAMENT™| Bone Void Filler Device Registry
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bonesupport Ab Industry-sponsored |
| Locations | 13 sites (Scottsdale, Arizona and 12 other locations) |
| Trial ID | NCT04244942 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who are scheduled to receive the CERAMENT BVF as part of their orthopedic treatment.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Scottsdale, Arizona and 12 other locations
- 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)
- Indiana University — Indianapolis, Indiana, United States (Terminated)
- OrthoIndy — Indianapolis, Indiana, United States (Completed)
- 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)
Study contacts
- Study coordinator: Brian M Bartholdi
- Email: brian.bartholdi@bonesupport.com
- Phone: 6178923927
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.