Evaluation of the Safety and Performance of the Neocement® Inject P
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBioceramed
About this trial
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® Inject P 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.
Eligibility criteria
Qualifiers
Adult males or females (age > 18 years old);
Patients with bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of Neocement® Inject P;
Patients who are able to sign an informed consent form (for data collection)
Patients with bone defects, which may be surgically created or result from traumatic injury to the bone;
Disqualifiers
Patients who are unable to understand consent and the objectives of the study;
Signs of local or systemic acute/ active or chronic infections;
Metabolic affections;
Severe degenerative diseases, conditions in which general bone grafting is not advisable;
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Bioceramed
Lead sponsor
Local Health Unit Barcelos/Esposende, Public Health Unit
Collaborator
Source ClinicalTrials.gov