Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT05676905
Eligibility Criteria:
Inclusion Criteria:
* Patients with bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of Neocement® / Neocement® Inject P.
* Age ≥ 18 years of both genders (male and female)
* Patient signed informed consent form (for data collection)
* Bone defects surgically created or osseous defects created from traumatic injury to the bone
* Bone skeletal defects that are not intrinsic to the stability of bone structure OR site which can be stabilized
Exclusion Criteria:
* Acute or chronic infection at the surgical site;
* Metabolic bone diseases;
* Severe degenerative disease conditions in which general bone grafting is not advisable;
* Active malignancy.
* Inability to understand consent and objectives of the study;
* Pregnant women or breastfeeding women;
* Unable to undergo medical monitoring for geographical, social or psychological reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05676905
Study Brief:
Protocol Section:
NCT05676905