Efficacy of a Vented Liner and Socket System for Individuals With Trans-femoral Amputation

The objective of the investigation is to measure the humidity within a transfemoral amputee's prosthesis during physical activity in a pre-heated room, using both the vented AeroFit system and a non-vented comparator. The AeroFit System is a vented suspension system for transfemoral amputees, and it is combined with both a vented liner and a vented socket. Both the liner and the socket are designed to allow humidity to evaporate from the residual limb skin and out of the socket. The system is intended to reduce sweat build-up on the amputees' residual limb. At least ten transfemoral amputees will be fitted to the AeroFit socket and liner. After a minimum of 2 weeks of adaptation, subjects will have two humidity measurement sessions on two separate days, one day for the investigational device and one for the comparator. Each measurement session will take place during the same time of the day. During the humidity measurement sessions, humidity and temperature sensors will be placed directly on the subject's residual limb, and the subject will walk for 20 minutes at self-selected walking speed on a treadmill in a pre-heated room of 28 degrees Celsius. After 20 minutes of walking and 10 minutes of rest, the subject will perform the four square step test and walk stairs and humidity and temperature measurements will be collected throughout the whole time. After the stairs activity, the subject will be seated and will remove the socket, liner and sensors. The subject group will be randomized into two groups, A and B. Group A's first measurement session will be using the investigational device, Group B's first measurement session will be using the comparator. Amputees often deal with sweat inside their prostheses, which can affect their suspension and skin health. The Aerofit system is intended to assist with that problem. The investigation is the first step in collecting a pivotal dataset to confirm the sweat build-up inside amputees' prosthesis is reduced with a breathable suspension system.