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:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
NCT ID:
NCT03103295
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 60 years
* Patients with long bone defects of critical size of the traumatic genesis;
* Lack of consolidation of bone fragments for at least 9 months;
* At least two attempts to achieve bone consolidation using traditional methods of treatment;
* A negative pregnancy test at women of childbearing age;
* Confirmation of participation in the study by signing The Written Informed Consent, personally or through a responsible caretaker;
Exclusion Criteria:
* The infection in the area of bone defect;
* History of prior cancer;
* Diabetes;
* Severe chronic liver diseases or kidneys disease in history
* Pregnancy;
* The presence of vascular, endocrine and somatic pathology which has a direct impact on the osteoreparation;
* Any other physical diseases in decompensation or subcompensation, or those that are rated as severe or moderate;
* Therapeutic issues or psychiatric disorders of a patient which would make the subject unsuitable to participate in this study or to complete it;
* Participation in another clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03103295
Study Brief:
Protocol Section:
NCT03103295