NCT04244942

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Mar 2020Mar 2028

First Submitted

Initial submission to the registry

January 15, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2020

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

8 years

First QC Date

January 15, 2020

Last Update Submit

September 24, 2025

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (9)

  • 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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    18 months

Secondary Outcomes (4)

  • Radiological assessment at 6 and 12 months. Objective assessment of regeneration

    6 Months

  • Radiological assessment at 6 and 12 months. Objective assessment of regeneration

    12 Months

  • Pain VAS score

    6, 12, and 18 Months

  • EQ-5D-3L

    6, 12, and 18 months

Interventions

CERAMENT BVFDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The racial, gender, and ethnic characteristics of the individuals approached for participation in this Observational Registry Study shall reflect the demographics of patients that would ordinarily received CERAMENT BVF for the treatment of their condition at the designated investigative centers. No individuals shall be excluded from participation in the Observational Registry Study based on race, nationality, ethnicity, gender or sexuality.

You may qualify if:

  • 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

You may not qualify if:

  • Any off-label use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

HonorHealth

Scottsdale, Arizona, 85258, United States

RECRUITING

Golden Orthopedic Knee, Hip, Shoulder and Foot Center

Boca Raton, Florida, 33434, United States

RECRUITING

Sports and Orthopedic Center

Boca Raton, Florida, 33434, United States

RECRUITING

Dr. Peter Merkle

Pompano Beach, Florida, 33064, United States

RECRUITING

Florida Orthopedic Foot & Ankle Center

Sarasota, Florida, 34233, United States

RECRUITING

James Cottom

Sarasota, Florida, 34233, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

TERMINATED

OrthoIndy

Indianapolis, Indiana, 46278, United States

COMPLETED

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

The Research Foundation of The State University of New York

Syracuse, New York, 13210, United States

RECRUITING

OrthoCarolina

Charlotte, North Carolina, 28207, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Central Study Contacts

Brian M Bartholdi

CONTACT

6178923927brian.bartholdi@bonesupport.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 28, 2020

Study Start

March 30, 2020

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

March 30, 2028

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(13)