Recruiting

Bone Void Filler

Sponsor:

BONESUPPORT AB

Code:

NCT04244942

Conditions

Orthopedic Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CERAMENT BVF

Study Details

Brief summary:

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

Conditions

Orthopedic Disorder

Study ID

NCT04244942

Start date

Mar 30, 2020

Status verified date

Sep, 2025

Completion date

Mar 30, 2028

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

CERAMENT BVF

CERAMENT BONE VOID FILLER is a synthetic biphasic bone graft substitute.

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 ]
  • 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: 18 months ]
  • Complaints 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 ]
  • Complaints 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: 18 months ]
  • Adverse events 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 and 18 months ]
  • Adverse events 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 ]
  • adverse device events 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: 18 months ]
  • SAEs 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 ]
  • SAEs 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: 18 months ]

Central Contacts and Locations

Central contacts

Brian M Bartholdi

6178923927brian.bartholdi@bonesupport.com

Locations

HonorHealth

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Judd Cummings, MD

16022588500jcummings@oso.md

Principal Investigator:

Judd Cummings, MD

Golden Orthopedic Knee, Hip, Shoulder and Foot Center

Recruiting

Boca Raton, Florida, United States, 33434

Contacts

Curtis Kephart, MD

drkephart@goldenortho.com

Principal Investigator:

Curtis Kephart, MD

Sports and Orthopedic Center

Recruiting

Boca Raton, Florida, United States, 33434

Contacts

Danahe Navarrete

19543023120dnavarrete@advancedresearchfl.com

Principal Investigator:

Manish Gupta, MD

Dr. Peter Merkle

Recruiting

Pompano Beach, Florida, United States, 33064

Contacts

Stephanie Tagland

stagland02@comcast.net

Principal Investigator:

Peter Merkle, MD

Florida Orthopedic Foot & Ankle Center

Recruiting

Sarasota, Florida, United States, 34233

Contacts

James Cottom, MD

19419248777jamescottom300@hotmail.com

Principal Investigator:

James Cottom, MD

James Cottom

Recruiting

Sarasota, Florida, United States, 34233

Contacts

James Cottom

19419248777jamescottom300@hotmail.com

Principal Investigator:

James Cottom, DPM

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Stephen Duncan, MD

stdunc2@uky.edu

Principal Investigator:

Stephen Duncan, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Santiago Lozano-Calderon, MD, PhD

The Research Foundation of The State University of New York

Recruiting

Syracuse, New York, United States, 13210

Contacts

Kayla Sweeney

3154648618sweenkay@upstate.edu

Principal Investigator:

Timothy Damron, MD

OrthoCarolina

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Justin Norwood

704-323-2267justin.norwood@orthocarolina.com

Principal Investigator:

Carroll P Jones, M.D.

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Elika Fanaeian

elika.fanaeian@uhhospitals.org

Principal Investigator:

George Ochenjele, MD

More Information

Sponsor

BONESUPPORT AB

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BONESUPPORT AB on 2025-09-29.