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

概要

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