Investigation Into the Functional Performance of a New Thermoplastic Elastomer (TPE) Transtibial Liner

The clinical investigation is designed as an uncontrolled open prospective, multicenter, 2 group, pre-test post-test study. Testing will be conducted in the USA and Canada at 3-6 clinics, depending on enrolment requirements. 20 subjects currently using the comparator liner will be recruited: 10 using cushion/sleeve and 10 using pin-lock. The study consists of 4 study events, requiring subjects to visit the clinic at least 4 times; as this study requires the manufacturing of a new socket, more than one iterations might be required. These events will be as follows

Inclusion Criteria: * Cognitive ability to understand all instructions and questionnaires in the study * Bi- or unilateral transtibial amputee, low to moderate impact * Amputee currently using a cushion (n=10) or a locking (n=10) 3 or 6 mm OWW Alpha Classic Uniform, or 3 mm OWW Alpha Classic Tapered liner * Willing and able to participate in the study and follow the protocol * Confident prosthetic users for more than 3 months * Older than 18 years Exclusion Criteria: * Users with cognitive impairment * Transfemoral amputees * Amputees not using a prosthesis for daily activities * Amputees not using OWW Alpha Classic cushion (n=10) or a locking (n=10), 3 or 6 mm OWW Alpha Classic Uniform, or 3 mm OWW Alpha Classic Tapered liners, as part of their primary prosthesis