Evaluation of the Safety and Performance of the Neocement® Inject P
Recruiting
Observational Study
Bone Defects
Orthopaedic Surgery (30 Minutes or Longer)
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 80 (estimated)
- Sponsor
- Bioceramed · Industry
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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, w…
Contacts