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Actively Recruiting

Age: 18Years +
All Genders
ID04244942

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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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