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Investigation Into the Functional Performance of a New Thermoplastic Elastomer (TPE) Transtibial Liner
Sponsor: Össur Iceland ehf
Summary
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
14
Start Date
2016-03-30
Completion Date
2019-01-30
Last Updated
2026-09-11
Healthy Volunteers
No
Conditions
Interventions
TPE Liner
Subjects are asked to change their primary prosthetic liner. This entails getting a new socket as well. Subjects are expected to use the new liner for up to 6 months. No other intervention is planned.
Locations (1)
Valley Institute of Prosthetics and Orthotics, Inc.
Bakersfield, California, United States