CERAMENT™| Bone Void Filler Device Registry

Orthopedic Disorder Clinical Trial

Official title:

CERAMENT™| Bone Void Filler Device Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04244942
• Other study ID #: S025/2018
• Status: Recruiting
• Start date: March 30, 2020
• Est. completion date: March 30, 2025

Study information

• Verified date: March 2024
• Source: BONESUPPORT AB
• Contact: Brian M Bartholdi
• Phone: 6178923927
• Email: brian.bartholdi[@]bonesupport.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Device:
• CERAMENT BVF
CERAMENT BONE VOID FILLER is a synthetic biphasic bone graft substitute.

Locations

Country	Name	City	State
United States	Golden Orthopedic Knee, Hip, Shoulder and Foot Center	Boca Raton	Florida
United States	Sports and Orthopedic Center	Boca Raton	Florida
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	OrthoCarolina	Charlotte	North Carolina
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Indiana University	Indianapolis	Indiana
United States	OrthoIndy	Indianapolis	Indiana
United States	University of Kentucky	Lexington	Kentucky
United States	Dr. Peter Merkle	Pompano Beach	Florida
United States	Florida Orthopedic Foot & Ankle Center	Sarasota	Florida
United States	James Cottom	Sarasota	Florida
United States	HonorHealth	Scottsdale	Arizona
United States	The Research Foundation of The State University of New York	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
BONESUPPORT AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Radiological assessment at 6 and 12 months. Objective assessment of regeneration	Bone healing	6 Months
Secondary	Radiological assessment at 6 and 12 months. Objective assessment of regeneration	Bone healing	12 Months
Secondary	Pain VAS score	Pain assessment at 6,12, and 18 months	6, 12, and 18 Months
Secondary	EQ-5D-3L	Functional assessment at 6, 12, and 18 months	6, 12, and 18 months