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 products 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 devices 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
Research Team
B
Brian M Bartholdi
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