Bone DefectsOrthopaedic Surgery (30 Minutes or Longer)
Study 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 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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, 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 Criteria:
* 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.
Primary outcome measure(s)
Performance Endpoint — 6 weeks; 3 months; 6 months and 12 months (if necessary) Bone consolidation on the surgery site (discrete variable: Yes or No), assessed by X-ray or CT scan.
Safety Endpoint — 6 weeks; 3 months; 6 months and 12 months (if necessary) The assessment of Adverse Events and Device deficiencies at least possibly related to Neocement® Inject P during the follow-up period of patients.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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