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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT02366702
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* All causes of limb amputation: congenital, trauma, vascular, limb salvage, infection.
* All transfemoral residual limb lengths: joint disarticulation, long, medium, short, very short.
* Subjects currently walk with entirely passive type prostheses daily.
* Subjects walk without assistive devices OR with single point cane.
* High-activity level walkers
Exclusion Criteria:
* Ages \< 18 or \> 45 years
* Medical comorbidities or existing conditions that may impede the subjects ability to complete the protocol excluding the amputations.
* Current medications or pharmaceutical interventions that may impede the subjects ability to complete the protocol.
* Any powered prosthetic component or prosthesis, including but not exclusive to: Ossur Proprio Foot, BiOM or BiOM T2 System Foot, Ossur Power Knee, Ossur Symbionic Leg.
* Subjects requiring a walker, crutches, quad cane, or other assistive devices excluding a single point cane.
* Low-activity level walkers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02366702
Study Brief:
Protocol Section:
NCT02366702