CERAMENT™| Bone Void Filler Device Registry

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

Study Overview

• Status: Recruiting
• Conditions: Orthopedic Disorder
• Intervention / Treatment: Device: CERAMENT BVF

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Brian M Bartholdi; Phone Number: 6178923927; Email: brian.bartholdi@bonesupport.com

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Recruiting
      • HonorHealth
      • Contact: Judd Cummings, MD; Phone Number: 602-258-8500; Email: jcummings@oso.md
      • Principal Investigator: Judd Cummings, MD
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Recruiting
      • Golden Orthopedic Knee, Hip, Shoulder and Foot Center
      • Contact: Curtis Kephart, MD; Email: drkephart@goldenortho.com
      • Principal Investigator: Curtis Kephart, MD
    • Boca Raton, Florida, United States, 33434
      • Recruiting
      • Sports and Orthopedic Center
      • Principal Investigator: Manish Gupta, MD
      • Contact: Danahe Navarrete; Phone Number: 954-302-3120; Email: dnavarrete@advancedresearchfl.com
    • Pompano Beach, Florida, United States, 33064
      • Recruiting
      • Dr. Peter Merkle
      • Contact: Stephanie Tagland; Email: stagland02@comcast.net
      • Principal Investigator: Peter Merkle, MD
    • Sarasota, Florida, United States, 34233
      • Recruiting
      • Florida Orthopedic Foot & Ankle Center
      • Principal Investigator: James Cottom, MD
      • Contact: James Cottom, MD; Phone Number: 941-924-8777; Email: jamescottom300@hotmail.com
    • Sarasota, Florida, United States, 34233
      • Recruiting
      • James Cottom
      • Contact: James Cottom; Phone Number: 941-924-8777; Email: jamescottom300@hotmail.com
      • Principal Investigator: James Cottom, DPM
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Terminated
      • Indiana University
    • Indianapolis, Indiana, United States, 46278
      • Completed
      • OrthoIndy
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky
      • Principal Investigator: Stephen Duncan, MD
      • Contact: Stephen Duncan, MD; Email: stdunc2@uky.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Santiago Lozano-Calderon, MD, PhD
      • Principal Investigator: Santiago Lozano-Calderon, MD, PhD
  • New York
    • Syracuse, New York, United States, 13210
      • Recruiting
      • The Research Foundation of The State University of New York
      • Principal Investigator: Timothy Damron, MD
      • Contact: Kayla Sweeney; Phone Number: 315-464-8618; Email: sweenkay@upstate.edu
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • OrthoCarolina
      • Contact: Justin Norwood; Phone Number: 704-323-2267; Email: justin.norwood@orthocarolina.com
      • Principal Investigator: Carroll P Jones, M.D.
      • Sub-Investigator: Kent Ellington, M.D.
      • Sub-Investigator: Scott Shawen, M.D.
      • Sub-Investigator: Todd Irwin, M.D.
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
      • Principal Investigator: George Ochenjele, MD
      • Contact: Elika Fanaeian; Email: elika.fanaeian@uhhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological assessment at 6 and 12 months. Objective assessment of regeneration	Bone healing	6 Months
Radiological assessment at 6 and 12 months. Objective assessment of regeneration	Bone healing	12 Months
Pain VAS score	Pain assessment at 6,12, and 18 months	6, 12, and 18 Months
EQ-5D-3L	Functional assessment at 6, 12, and 18 months	6, 12, and 18 months

Collaborators and Investigators

• Sponsor: BONESUPPORT AB

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2020
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: S025/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No