RecruitingNCT04244942

CERAMENT™| Bone Void Filler Device Registry


Sponsor

BONESUPPORT AB

Enrollment

300 participants

Start Date

Mar 30, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The CERAMENT Bone Void Filler (BVF) Device Registry is an international observational study that tracks outcomes for patients who receive CERAMENT BVF — a synthetic bone substitute used to fill gaps in bone after surgery for fractures or infections. Instead of waiting for natural bone to regrow or using a bone graft, surgeons can fill the void with this material, which gradually integrates into the bone. This registry collects real-world safety and effectiveness data from patients treated in clinical practice. Patients must be 18 or older and treated at a participating healthcare facility. You may be eligible if... - You are 18 or older - You are receiving CERAMENT BVF as part of your surgical treatment at a participating center - You have received and signed the patient information and consent forms You may NOT be eligible if... - You meet any exclusion criteria listed in the product's instructions for use - CERAMENT BVF is being used in an off-label way for your treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECERAMENT BVF

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


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

The Research Foundation of The State University of New York

Syracuse, New York, United States

OrthoCarolina

Charlotte, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT04244942


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