CERAMENT™ Bone Void Filler Device Registry
This study is a registry that collects information on how a medical device called CERAMENT™ Bone Void Filler performs during normal use. This device is a synthetic (man-made) material used to fill bone voids (empty spaces in bone). The study is looking for adults aged 18 and older who are receiving CERAMENT™ Bone Void Filler as part of their treatment at a participating clinic. The main goal is to track any unexpected device performance or complaints that occur, with formal reviews at 12 and 18 months after surgery. The current status of this study is unclear.
- Study design
- This is an observational study, meaning researchers will collect data on how the device is used in real-world settings. It plans to enroll 300 participants.
- What's involved
- You would receive CERAMENT™ Bone Void Filler as part of your treatment. Researchers will then collect information on any unexpected device performance or complaints.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will formally review device performance and complaints at 12 and 18 months after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CERAMENT™| Bone Void Filler Device Registry
At a glance
Conditions
NCT04244942
Where you'd take part
This study runs at 13 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Dr. Peter Merkle
Pompano Beach, Floridastudy coordinator listed
Recruiting
Florida Orthopedic Foot & Ankle Center
Sarasota, Floridastudy coordinator listed
Recruiting
Golden Orthopedic Knee, Hip, Shoulder and Foot Center
Boca Raton, Floridastudy coordinator listed
Recruiting
HonorHealth
Scottsdale, Arizonastudy coordinator listed
Recruiting
James Cottom
Sarasota, Floridastudy coordinator listed
Recruiting
OrthoCarolina
Charlotte, North Carolinastudy coordinator listed
Recruiting
Sports and Orthopedic Center
Boca Raton, Floridastudy coordinator listed
Recruiting
The Research Foundation of The State University of New York
Syracuse, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- 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 months12 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 months18 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 months12 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 months18 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 months12 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 months12 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 months18 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 months12 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 months18 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