Össur Iceland ehf

A national, multi-center registry of patients using lower-limb prosthesis, their profiles and devices, and their long-term follow-up and clinical outcomes.

The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars:
1. The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a movement with more amplitude and closer to the physiological movement of the ankle, and an increase in the power of the ankle, especially in the terminal support phase.
2. The technology of the three carbon blades (plantar, upper and median), including a wider plantar blade, split in the middle of the foot with a separate toe to provide efficiency over the entire length to the big toe, bringing more power to the impulse and more control, but also increased stability until the terminal support phase.
3. An anatomical foot cosmetic, to adapt and optimize the function of the blade: of light manufacture, with an adherent sole for more stability barefoot, it guarantees physiological plantar pressure during the unwinding of the foot.
The aim of this study is to demonstrate that compared to a class III ESAR foot, the PRO-FLEX PIVOT® foot improves patient mobility with a validated score.

The goal of this clinical investigation is to evaluate the clinical benefits of a ventilating suspension interface for individuals with transfemoral amputation. The main aim of the investigation will be to evaluate the clinical user-reported benefits to skin health from using a ventilating lower limb prosthetic suspension system and compare it to a non-ventilating suspension system.