IceExplore TF Liner Alpha Investigation

Single group prospective repeated measures comparing breathable liner and breathable socket to conventional enclosed silicone liner and socket system. IceExploreTF liner, the investigational device, is intended to function as part of a system that replaces a missing limb, a prosthetic interface with suction suspension technology and force transmission properties. More specifically, it is intended to reduce the skin humidity associated with the closed environment of predicate liners whilst maintaining secure suspension and user comfort. The literature indicates that the impact of sweat and heat on quality of life for trans-femoral amputees is significant and actions to improve sweat and heat issues with the prosthesis can contribute substantially to the well-being of amputees and could additionally have a positive effect on residual limb skin health.

Inclusion Criteria: * 50Kg\< body weight \< 136Kg * Cognitive ability to understand all instructions and questionnaires in the study * Unilateral/bilateral trans-femoral amputees * Activity level: high K2-K4 * Liner: Össur Seal-In TF silicone liner * Socket: All subjects shall be using Direct Socket, and have been for minimum 4 weeks * Willing and able to participate in the study and follow the protocol * Confident prosthetic users for more than 3 months * Older than 18 years * Residual limb profile: Standard or conical. At least 30% of subjects must be either conical or standard. * Subgroup: Minimum 10 subjects shall fit inclusion for subgroup of amputees with history of skin issues. Exclusion Criteria: * 50Kg\> body weight \> 136Kg * Users with cognitive impairment * Participating in another research study