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 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT07076602
Eligibility Criteria:
Inclusion Criteria:
* Minor aged 7 and over
* Congenital (transverse agenesis with break in limb continuity) or acquired (any etiology) transfemoral or transtibial amputation. \[In the case of femoral agenesis, the flexion axis of the prosthetic knee must coincide with the contralateral one to optimize the analysis of the kinematic parameters of gait\].
* Definitive prosthesis in place (no restriction on choice of prosthetic components)
* Legal representatives not opposing participation in the study for the child
Exclusion Criteria:
* Revision surgery on the residual limb within the last 3 months
* Progressive pathology associated with amputation (unstabilized sarcoma for example) which can strongly influence walking and/or energy expenditure
* Patient already included in an interventional research protocol that could lead to bias in the present study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT07076602
Study Brief:
Protocol Section:
NCT07076602