Evaluation of the Safety and Performance of the Neocement® Inject P
Recruiting now
Conditions studied: Bone Defects, Orthopaedic Surgery (30 Minutes or Longer)
In brief
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.
Key facts
- Study ID
- NCT06973239
- Run by
- Bioceramed
- People needed
- 80
- Starts
- 2025-09-05
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
- Patients with bone skeletal defects that are not intrinsic to the stability of the bone structure or with a site that can be stabilized;
You may not qualify if…
- 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;
- Implementation sites that allow product migration;
- Conditions which require structural support in the skeletal system;
- Conditions where the implantation site is unstable and not rigidly fixated;
- Sensibility to the implantable materials;
- Known hypersensitivity to the implant material.
Where it is running
- Unidade Local de Saúde Esposende/Barcelos — Barcelos, Portugal (enrolling)
Full record on ClinicalTrials.gov
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