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 — DEVICECERAMENT 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
- Brian M Bartholdi6178923927
Locations (13)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| HonorHealth | Scottsdale | Arizona | 85258 | Judd Cummings, MD (PRINCIPAL_INVESTIGATOR) |
| Golden Orthopedic Knee, Hip, Shoulder and Foot Center | Boca Raton | Florida | 33434 | Curtis Kephart, MD Curtis Kephart, MD (PRINCIPAL_INVESTIGATOR) |
| Sports and Orthopedic Center | Boca Raton | Florida | 33434 | Manish Gupta, MD (PRINCIPAL_INVESTIGATOR) |
| Dr. Peter Merkle | Pompano Beach | Florida | 33064 | Stephanie Tagland Peter Merkle, MD (PRINCIPAL_INVESTIGATOR) |
| Florida Orthopedic Foot & Ankle Center | Sarasota | Florida | 34233 | James Cottom, MD (PRINCIPAL_INVESTIGATOR) |
| James Cottom | Sarasota | Florida | 34233 | James Cottom, DPM (PRINCIPAL_INVESTIGATOR) |
| Indiana University | Indianapolis | Indiana | 46202 | - |
| OrthoIndy | Indianapolis | Indiana | 46278 | - |
| University of Kentucky | Lexington | Kentucky | 40536 | Stephen Duncan, MD Stephen Duncan, MD (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Santiago Lozano-Calderon, MD, PhD Santiago Lozano-Calderon, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| The Research Foundation of The State University of New York | Syracuse | New York | 13210 | Timothy Damron, MD (PRINCIPAL_INVESTIGATOR) |
| OrthoCarolina | Charlotte | North Carolina | 28207 | 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 Center | Cleveland | Ohio | 44106 | Elika Fanaeian George Ochenjele, MD (PRINCIPAL_INVESTIGATOR) |
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