CERAMENT™| Bone Void Filler Device Registry

Recruiting

• Conditions: Orthopedic Disorder

• Registration Number: NCT04244942
• Lead Sponsor: BONESUPPORT AB

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-28
• Study Start: 2020-03-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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
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	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
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 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	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
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	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

Secondary Outcome Measures

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

Trial Locations

Locations (13)

HonorHealth; 🇺🇸 Scottsdale, Arizona, United States

Golden Orthopedic Knee, Hip, Shoulder and Foot Center; 🇺🇸 Boca Raton, Florida, United States

Sports and Orthopedic Center; 🇺🇸 Boca Raton, Florida, 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

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

OrthoIndy; 🇺🇸 Indianapolis, Indiana, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

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