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 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT05555459
Eligibility Criteria:
Inclusion Criteria:
1. Read the patient information bulletin on the study and signed the patient consent form
2. Adult patient (over 18-year-old)
3. Suitable and in need for surgical lower limb operation listed in the indications of this study that requires fastening of bone structures with screws (or an alternative attachment method) in the ankle or foot area, according to a statement of the investigator surgeon
4. Ability to fill in questionnaires.
5. Willingness to comply with rehabilitation instructions.
6. Availability for follow-up visits.
Exclusion Criteria:
1. Active infection
2. Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower limb
3. Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder)
4. Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.)
5. High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation
6. Patients with significant neuropathy
7. Pregnancy
8. Patients who refuse to participate
9. Lower limb tumor or metastasis
10. Complex Regional Pain Syndrome (CRPS) in operated foot
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05555459
Study Brief:
Protocol Section:
NCT05555459