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 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT06326827
Eligibility Criteria:
Inclusion Criteria:
1. Patient is male or female, 18 - 85 years old;
2. Patient is willing and able to give written informed consent;
3. Patient is able to comply with a prior medical examination;
4. Patient is or has been scheduled for a surgical procedure to correct epiphyso-metaphyseal and/or metaphyso-diaphyseal bone defect in one of the following anatomical locations:
* Proximal humerus ▪ Distal radius
* Distal femur ▪ Proximal tibia ▪ Distal tibia
5. Patient is willing and able to comply with the study procedures during surgery and the post-surgical follow up period, up to 12 months.
Exclusion Criteria:
1. Patient has had an infection in the same extremity within last 24 months;
2. Patient has signs of necrosis at the surgical site;
3. Patient has cellulitis;
4. Patient has granuloma or non-curetted cyst;
5. Patient has an history of uncontrolled diabetes;
6. Patient is alcoholic and/or heavy smoker (\> 20 cigarettes per day);
7. Patient has a congenital or acquired immunodeficiency;
8. Patient has severe bone loss (≥ 40cm3);
9. Patient is on long-term steroidal therapy or treatment acting on the calcium or phosphorus metabolism;
10. Patient is or has been scheduled for surgery that would involve intra-articular implantation of the study device;
11. Patient who has or had an uncontained bone defect created as a result of trauma injury or surgically created;
12. Patient was exposed to any radiation (e.g. X-Rays, handling of radiolabelled materials) other than the normal background radiation within the 12 months before the screening visit;
13. Patient is pregnant;
14. Patient who is an employee at the study site;
15. Patient is known to be non-compliant with medical treatment or follow-up
16. Patient has any significant or unstable medical/psychiatric condition that, in the opinion of the Investigator, would interfere with their ability to participate in the study;
17. Patient is currently enrolled or planning to enrol in another clinical study or treatment with another investigational drug/device that may interfere with the assessments, visits or outcomes of this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06326827
Study Brief:
Protocol Section:
NCT06326827