Actively Recruiting
CERAMENT Bone Void Filler Device Registry for Orthopedic Disorders
Led by BONESUPPORT AB · Updated on 2025-09-29
300
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational study is focused on collecting data about the performance of CERAMENT BONE VOID FILLER, a synthetic biphasic bone graft substitute, when used in typical medical practice for orthopedic disorders. The study is sponsored by BONESUPPORT AB and aims to gather information on device performance and patient outcomes to understand its use in real-world settings. Participants will receive CERAMENT BVF as part of their treatment at approved healthcare centers following the product's instructions for use. Data collection includes monitoring unexpected device performance, complaints, adverse events, and serious adverse events during surgery and continuing up to 18 months after treatment. Radiological assessments, pain scores, and quality of life evaluations will be conducted at intervals throughout the study. During the study, participants will undergo scheduled reviews at 6, 12, and 18 months to assess device-related outcomes and healing progress using imaging and questionnaires. Researchers will track safety events and gather patient-reported outcomes such as pain levels and quality of life. Participation involves following up with healthcare providers over this period to provide ongoing data for comprehensive evaluation of the device's performance.
CONDITIONS
Brief Title
CERAMENT™| Bone Void Filler Device Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years and over (on the day of surgery)
- Receive CERAMENT BVF as part of treatment at participating healthcare centers following product instructions
- Have received patient information and signed informed consent
You will not qualify if you...
- Any exclusion criteria as per instructions for use for CERAMENT BVF
- Any off-label use of CERAMENT BVF
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo implantation of the CERAMENT Bone Void Filler device as part of their orthopedic treatment.
1 visit (in-person)
Duration - Up to 18 months
Participants are monitored over time for device performance, adverse events, and recovery progress following implantation.
Visits at approximately 6, 12, and 18 months
Trial Site Locations
Total: 13 locations
1
HonorHealth
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Golden Orthopedic Knee, Hip, Shoulder and Foot Center
Boca Raton, Florida, United States, 33434
Actively Recruiting
3
Sports and Orthopedic Center
Boca Raton, Florida, United States, 33434
Actively Recruiting
4
Dr. Peter Merkle
Pompano Beach, Florida, United States, 33064
Actively Recruiting
5
Florida Orthopedic Foot & Ankle Center
Sarasota, Florida, United States, 34233
Actively Recruiting
6
James Cottom
Sarasota, Florida, United States, 34233
Actively Recruiting
7
Indiana University
Indianapolis, Indiana, United States, 46202
Terminated
8
OrthoIndy
Indianapolis, Indiana, United States, 46278
Completed
9
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
10
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
11
The Research Foundation of The State University of New York
Syracuse, New York, United States, 13210
Actively Recruiting
12
OrthoCarolina
Charlotte, North Carolina, United States, 28207
Actively Recruiting
13
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
B
Brian M Bartholdi
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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