CERAMENT™| Bone Void Filler Device Registry

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
BONESUPPORT AB
Study ID
NCT04244942
Status
Recruiting

Conditions

  • Orthopedic Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CERAMENT BVF — DEVICE
    CERAMENT BONE VOID FILLER is a synthetic biphasic bone graft substitute.

Study Details

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

Key Dates

Start date
Mar 30, 2020
Status verified
Sep 2025
Primary completion
Mar 30, 2028
Completion
Mar 30, 2028

Study Design

Enrollment
300 participants (estimated)

Primary Outcome Measure

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 [ Time Frame: 12 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
HonorHealthScottsdaleArizona85258
Judd Cummings, MD
16022588500
Judd Cummings, MD (PRINCIPAL_INVESTIGATOR)
Golden Orthopedic Knee, Hip, Shoulder and Foot CenterBoca RatonFlorida33434
Curtis Kephart, MD
Curtis Kephart, MD (PRINCIPAL_INVESTIGATOR)
Sports and Orthopedic CenterBoca RatonFlorida33434
Danahe Navarrete
19543023120
Manish Gupta, MD (PRINCIPAL_INVESTIGATOR)
Dr. Peter MerklePompano BeachFlorida33064
Stephanie Tagland
Peter Merkle, MD (PRINCIPAL_INVESTIGATOR)
Florida Orthopedic Foot & Ankle CenterSarasotaFlorida34233
James Cottom, MD
19419248777
James Cottom, MD (PRINCIPAL_INVESTIGATOR)
James CottomSarasotaFlorida34233
James Cottom
19419248777
James Cottom, DPM (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202-
OrthoIndyIndianapolisIndiana46278-
University of KentuckyLexingtonKentucky40536
Stephen Duncan, MD
Stephen Duncan, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Santiago Lozano-Calderon, MD, PhD
Santiago Lozano-Calderon, MD, PhD (PRINCIPAL_INVESTIGATOR)
The Research Foundation of The State University of New YorkSyracuseNew York13210
Kayla Sweeney
3154648618
Timothy Damron, MD (PRINCIPAL_INVESTIGATOR)
OrthoCarolinaCharlotteNorth Carolina28207
Justin Norwood
704-323-2267
Carroll P Jones, M.D. (PRINCIPAL_INVESTIGATOR)
Kent Ellington, M.D. (SUB_INVESTIGATOR)
Scott Shawen, M.D. (SUB_INVESTIGATOR)
Todd Irwin, M.D. (SUB_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
Elika Fanaeian
George Ochenjele, MD (PRINCIPAL_INVESTIGATOR)

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