Actively Recruiting
Evaluation of the Safety and Performance of the Neocement®
Led by Bioceramed · Updated on 2026-02-04
80
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
Sponsors
B
Bioceramed
Lead Sponsor
L
Local Health Unit Barcelos/Esposende, Public Health Unit
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation, targeting submission to the new Medical Device Regulation (EU) 2017/745.
CONDITIONS
Official Title
Evaluation of the Safety and Performance of the Neocement®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males or females (age > 18 years old)
- Patients with bone defect treatment meeting predefined criteria in Neocement4 Instructions For Use
- Patients able to sign an informed consent form for data collection
- Patients with bone defects from surgical creation or traumatic injury
- Patients with bone skeletal defects that do not compromise bone stability or are in sites that can be stabilized
You will not qualify if you...
- Patients unable to understand consent or study objectives
- Presence of local or systemic acute, active, or chronic infections
- Metabolic disorders affecting eligibility
- Severe degenerative diseases where bone grafting is not advised
- Implantation sites that allow product migration
- Conditions requiring structural skeletal support
- Sites that are unstable and not rigidly fixated
- Sensitivity to implantable materials
- Known hypersensitivity to the implant material
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Unidade Local de Saúde Esposende/Barcelos
Barcelos, Portugal
Actively Recruiting
Research Team
A
Alexandre Barros
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here