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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT03836404
Eligibility Criteria:
Inclusion Criteria:
1. Male or female Patients.
2. Patients aged ≥ 18 and ≤ 70 years old.
3. Patients requiring iliac crest reconstruction secondary to pelvic fusion.
4. Patients understanding the nature of the study and providing their informed consent to participation.
5. Patients willing and able to attend the visits and procedures foreseen by study protocol.
Exclusion Criteria:
1. Patients with bone infections at the time of enrolment.
2. Patients with bone malignant tumor(s) at the time of enrolment.
3. Patients who have been treated with chemotherapy or radiotherapy within 12 months before the study enrolment.
4. Patients with concomitant infectious systemic diseases at the time of enrolment.
5. Patients with known inflammatory systemic diseases at the time of enrolment.
6. Patients with concomitant myeloproliferative disorders at the time of enrolment.
7. Patients currently treated with systemic immunosuppressive agents, including steroids.
8. Patients with active autoimmune disease.
9. Patients with coagulopathy or bleeding disorders.
10. Patients who have received a previous treatment of bone substitution in the same anatomical site.
11. Patients with known or suspected allergy or hypersensitivity to the GreenBone Implant components.
12. Patients who are participating or have participated in any other conflicting studies within the 30 days before the study enrolment. (This does not include patients who have taken part in other non-conflicting non-interventional or observational studies.
These patients may still be eligible).
13. Pregnant women and/or women that intend to be pregnant within 6 or 12 months from surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03836404
Study Brief:
Protocol Section:
NCT03836404