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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT07209033
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 70 years.
2. Subject signed informed consent form and is willing to participate in the follow-up visits.
3. Subject with an existing acute primary bone defect in one of the following groups:
1. Long bones of the lower extremity (including articular tibia plateau acute fracture).
2. Bones of the foot (including articular calcaneus acute fracture).
4. Subject scheduled for orthopedic procedure with bone substitute material.
5. Subject with bone defects volume that can be completely filled using a maximum of the one largest FlexiOss® fitting.
Exclusion Criteria:
1. Subject with alcohol dependence syndrome or any history of substance abuse within the past year.
2. Pregnancy or breastfeeding.
3. Subject participates in another clinical trial.
4. Unstable mental condition or psychiatric concomitant disease.
5. Diagnosed severe degenerative, metabolic bone disease or any condition that in opinion of the Investigator could adversely affect bone healing and regeneration.
6. Subject with known allergies or hypersensitivity to any components of the FlexiOss® biocomposite material
7. Subject with active cancer disease and/or during related oncological treatment.
8. Contraindications for computed tomography angiography according to the site Standard of Care include, but are not limited to, allergic reactions to contrast agents and impaired renal function.
9. Subject with severe comorbidities that could interfere with the study outcomes or pose a risk during surgery and rehabilitation.
10. Any other condition precluding implantation of FlexiOss®.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07209033
Study Brief:
Protocol Section:
NCT07209033