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Purpose

A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Case-Only
Time Perspective
Prospective

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Cale Jacobs, PhD
859-797-8197
cale.jacobs@uky.edu

More Details

NCT ID
NCT04244942
Status
Recruiting
Sponsor
BONESUPPORT AB

Study Contact

Brian M Bartholdi
6178923927
brian.bartholdi@bonesupport.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.