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 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT06400732
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 years old
2. Expressed willingness to participate in the study by signing and dating the informed consent form
3. Has a segmental bone defect, or limb length defect of at least 2 mm up to ≤ 120 mm, considered suitable for correction with an intramedullary lengthening nail, as confirmed by radiographs.
Exclusion Criteria:
1. Conditions that tend to retard healing such as blood supply limitations, peripheral vascular disease, or evidence of inadequate vascularity
2. Poor bone quality that would prevent adequate fixation of the device
3. Compromised capacity for healing
4. Metal allergies and sensitivities
5. Patients in which the implant would cross open, healthy epiphyseal growth plates
6. Insufficient intramedullary space which would lead to cortical weakening or vascular damage during implantation
7. Body weight of \> 100 kg
8. No free access for proximal insertion of the intramedullary transport and lengthening nail (e.g., coxa valga)
9. No reliable exclusion of bone infection
10. Expected non-compliance, mentally ill patient or patient with clouded consciousness
11. Pregnancy
12. Pre-existing nerve palsies
13. Bone defect larger than 120 mm
14. Gustilo Open Fracture Classification Grade IIIB or IIIC
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06400732
Study Brief:
Protocol Section:
NCT06400732