Status:
RECRUITING
Evaluation of the Safety and Performance of the Neocement® Inject P
Lead Sponsor:
Bioceramed
Collaborating Sponsors:
Local Health Unit Barcelos/Esposende, Public Health Unit
Conditions:
Bone Defects
Orthopaedic Surgery (30 Minutes or Longer)
Eligibility:
All Genders
18+ years
Brief Summary
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 appl...
Detailed Description
Neocement® Inject P represents a breakthrough in orthopaedic biomaterials, meticulously engineered to enhance bone repair and regeneration. This synthetic bone substitute combines tetracalcium phospha...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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.
Key Trial Info
Start Date :
September 5 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06973239
Start Date
September 5 2025
End Date
June 1 2027
Last Update
October 2 2025
Active Locations (1)
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1
Unidade Local de Saúde Esposende/Barcelos
Barcelos, Portugal