New liner aims to improve prosthetic fit for amputees
NCT ID NCT02622919
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Researchers are testing a new thermoplastic elastomer liner for people who use a below-knee prosthesis. The study enrolls 14 adults who currently use a cushion or pin-lock liner and asks them to switch to the new liner for up to six months. Participants visit the clinic several times to rate suspension, comfort, and residual limb health. The goal is to see how the liner performs in daily use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a new thermoplastic elastomer prosthetic liner
- What this could lead to
- If the liner performs well, it could offer people with below-knee amputations another option for a comfortable, secure fit.
- What could go wrong
- This is a small, uncontrolled study with no comparison group, so improvements may reflect the new socket rather than the liner itself. Results may not apply to all prosthetic users.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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14 people
The number who actually took part.
- Started
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Mar 2016
- Finished
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Jan 2019
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Valley Institute of Prosthetics and Orthotics, Inc.
Bakersfield, California, 93301, United States