Amputation StumpsNCT02622919
Investigation Into the Functional Performance of a New Thermoplastic Elastomer (TPE) Transtibial Liner
A study testing TPE Liner in people with Amputation Stumps, run by Össur Iceland ehf at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation Stumps
- What is being tested?
- TPE Liner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2016to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Valley Institute of Prosthetics and Orthotics, Inc.
Bakersfield, California, 93301
About this study
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
Read the detailed description
The study is of an uncontrolled open prospective multicentre 2 group pre-test post-test design.
- Recruitment phase Potential subjects will be identified from the customer base of the Local Principal Investigator (LPI). LPI evaluates, based on previous experience of interaction with and servicing of patients, if a potential participant is cognitively capable. If a potential participant fits the inclusion and exclusion criteria the LPI will contact them via telephone. During the telephone call the LPI will verify if they are interested in participating in a study. If interest is expressed at this point they will answer some screening questions and if the eligibility criteria are met an appointment will be made for the clinical visit and signing of the ICF. Questions relating to the duration of the study, number of clinical visits required and the investigational device will be answered.
The LPI will communicate to the study monitor the number of users he has identified that meet the inclusion criteria and are willing to participate.
ii) Test procedure 3-10 users will be recruited at each site. User Profile instrument will be filled in at the initial visit. It will be filled in by the CPI/LPI with input from the subject.
Baseline instrument will also be filled in at the initial visit. It consists of 5 parts: Usability, Suspension Questionnaire, PEQ - Residual Limb Health (PEQ-RLH), Comfort and other (noise and satisfaction). They only include VAS items and comment boxes. Additionally the pistoning test output is documented at the end.
The first part, socket fit comfort, of the Socket fitting instrument will be administrated each time as required, depending on iterations needed. CPO feedback, usability and comfort will only be administrated when the subject comes in for the first time for the fitting.
The 2 week follow up instrument will be administrated at the 2 week post successful fitting visit. It consists of 5 parts: Usability, Suspension Questionnaire, PEQ-RLH, and Comfort and Other; same as Baseline. Additionally the pistoning test output for both the trial liner (ICEROSS TPE) and is ICEROSS COMFORT is documented at the end.
The Retrofitting instrument is also administrated at study event 3 (expected visit 3).
The instrument used at the 6 month follow up consists of 4 parts: Suspension Questionnaire, PEQ-RLH, Comfort, and Other. The Other part has additional questions compared to the instruments used at earlier visits.
All items are in-house developed except for the socket fit comfort score[4] and PEQ-RLH[5].
iii) Visit Schedule and forms to fill out There are at least four scheduled study events. Each visit, except when fitting to trial product will take approximately 2 hours. The trial product fitting visits (event nr. 2, 2a, 2b, etc.) should last for no more than 30 minutes.
The first event is a visit within the normal treatment procedures of prosthetic care when the users are measured for a new socket. The ICF will be signed prior to any study activity. During the visit the subjects will also fill in the User Profile and Baseline instruments, with the help of their CPO as required.
This test, as is standard for liner testing, requires that the users will be fitted with a new socket. Attaining a proper fit of a new socket requires at least one iteration, often more, and few days to complete, and hence some users might require more study visits than others.
The second study event will be 1-2 weeks post first visit, when the new socket is ready. Subjects will come in and fit the new socket while wearing the investigational device. To verify that the socket is acceptable subjects will be asked to fill in the Socket fitting instrument. If the outcome is positive the subject will be scheduled for the 2 week follow up and subject goes home with the new prosthetic liner. If not, a new socket must be made or adjustments to the one manufactured and another visit set up for this event.
The third study event is the 2 week follow up. During the visit the subject will fill in the 2 week follow up instrument and the Retrofitting instrument, after retrofitting. Subject keeps using the investigational device.
The final study event, and expected fourth visit, is at 6 months post successful fitting. The subject fills in the 6 month follow up instrument, receives compensation as applicable and ends study participation.
The subjects will return the trial device at the 6 month visit.
- Conditions
- Amputation Stumps
- Being tested
- TPE Liner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPE LinerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | New TPE liner:
Subjects get a new socket and are fitted with a new liner under development. Subjects use the liner for 6 months. Receives: Device: TPE Liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Suspension Quality Score
Suspension Score: Suspension quality was assessed using an in-house developed questionnaire consisting of 7 items evaluating perceived prosthetic suspension and security throughout the day. The items assessed stability in the socket, suspension in the morning, afternoon, and evening, vertical movement (pistoning), rotational movement, and the influence of perspiration on suspension. Each item was rated on a 10-cm Visual Analog Scale (VAS) ranging from 0 to 10. Depending on the item, 0 represented the poorest suspension outcome (e.g., completely disagree, extreme influence of perspiration) and 10 represented the best suspension outcome (e.g., completely agree, no influence of perspiration). Item scores were averaged to obtain an overall suspension score ranging from 0 to 10, with higher scores indicating better perceived suspension quality and security.
Measured: 2 weeks
Residual Limb Health Subscale Score (Average of 6 Items)
Residual Limb Health Subscale Score (average of 6 items). Residual limb health was assessed using the Prosthetic Evaluation Questionnaire - Residual Limb Health (PEQ-RLH) subscale, which evaluates sweating, odor, swelling, rashes, ingrown hairs, and sores or blisters on the residual limb. Participants rated each item on a 10-cm Visual Analog Scale (VAS) ranging from 0 to 10, where 0 represents the poorest residual limb health (most severe symptoms) and 10 represents the best residual limb health (no symptoms). The overall PEQ-RLH score was calculated as the mean of the six item scores, resulting in a total score ranging from 0 to 10. Higher scores indicate better residual limb health and fewer skin-related problems.
Measured: 2 weeks
Number of Subjects That Drop Out Because of Dissatisfaction With the Liner (Not Socket Related).
Number of participants who discontinued study participation because of dissatisfaction with the investigational liner, excluding discontinuations related to socket fit or socket-related issues. Lower values indicate better user acceptance of the investigational liner.
Measured: 6 months
Secondary outcomes (2)
Socket Fit Comfort VAS Score
Socket Fit Comfort: Participants rated the comfort of socket fit using a 10-cm Visual Analog Scale (VAS). Scores ranged from 0 to 10, where 0 = extremely uncomfortable socket fit and 10 = extremely comfortable socket fit. Higher scores indicate better perceived socket fit comfort.
Measured: 2 weeks
Participants Able to Use the Trial Liner as Their Primary Prosthesis
Number of participants able to use the investigational liner as their primary prosthesis during the study period. Higher values indicate successful use of the liner under normal conditions of use.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study start30 Mar 2016
- Primary completion15 Nov 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Amputation StumpsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Justin Pratt, CPO, Principal investigator, Össur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622919
- Sponsor's protocol ID
- CIP2015061050
- Status last verified
- Sep 2025
- First submitted
- 19 Nov 2015
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Functional Performance of a New Thermoplastic Elastomer (TPE) Transtibial Liner
- ClinicalTrials.gov ID
- NCT02622919
- Acronym / sponsor ID
- CIP2015061050
- Conditions
- Amputation Stumps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 7 Dec 2015 (estimated)
- Results
- Posted 11 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The study is of an uncontrolled open prospective multicentre 2 group pre-test post-test design.
- Recruitment phase Potential subjects will be identified from the customer base of the Local Principal Investigator (LPI). LPI evaluates, based on previous experience of interaction with and servicing of patients, if a potential participant is cognitively capable. If a potential participant fits the inclusion and exclusion criteria the LPI will contact them via telephone. During the telephone call the LPI will verify if they are interested in participating in a study. If interest is expressed at this point they will answer some screening questions and if the eligibility criteria are met an appointment will be made for the clinical visit and signing of the ICF. Questions relating to the duration of the study, number of clinical visits required and the investigational device will be answered.
The LPI will communicate to the study monitor the number of users he has identified that meet the inclusion criteria and are willing to participate.
ii) Test procedure 3-10 users will be recruited at each site. User Profile instrument will be filled in at the initial visit. It will be filled in by the CPI/LPI with input from the subject.
Baseline instrument will also be filled in at the initial visit. It consists of 5 parts: Usability, Suspension Questionnaire, PEQ - Residual Limb Health (PEQ-RLH), Comfort and other (noise and satisfaction). They only include VAS items and comment boxes. Additionally the pistoning test output is documented at the end.
The first part, socket fit comfort, of the Socket fitting instrument will be administrated each time as required, depending on iterations needed. CPO feedback, usability and comfort will only be administrated when the subject comes in for the first time for the fitting.
The 2 week follow up instrument will be administrated at the 2 week post successful fitting visit. It consists of 5 parts: Usability, Suspension Questionnaire, PEQ-RLH, and Comfort and Other; same as Baseline. Additionally the pistoning test output for both the trial liner (ICEROSS TPE) and is ICEROSS COMFORT is documented at the end.
The Retrofitting instrument is also administrated at study event 3 (expected visit 3).
The instrument used at the 6 month follow up consists of 4 parts: Suspension Questionnaire, PEQ-RLH, Comfort, and Other. The Other part has additional questions compared to the instruments used at earlier visits.
All items are in-house developed except for the socket fit comfort score[4] and PEQ-RLH[5].
iii) Visit Schedule and forms to fill out There are at least four scheduled study events. Each visit, except when fitting to trial product will take approximately 2 hours. The trial product fitting visits (event nr. 2, 2a, 2b, etc.) should last for no more than 30 minutes.
The first event is a visit within the normal treatment procedures of prosthetic care when the users are measured for a new socket. The ICF will be signed prior to any study activity. During the visit the subjects will also fill in the User Profile and Baseline instruments, with the help of their CPO as required.
This test, as is standard for liner testing, requires that the users will be fitted with a new socket. Attaining a proper fit of a new socket requires at least one iteration, often more, and few days to complete, and hence some users might require more study visits than others.
The second study event will be 1-2 weeks post first visit, when the new socket is ready. Subjects will come in and fit the new socket while wearing the investigational device. To verify that the socket is acceptable subjects will be asked to fill in the Socket fitting instrument. If the outcome is positive the subject will be scheduled for the 2 week follow up and subject goes home with the new prosthetic liner. If not, a new socket must be made or adjustments to the one manufactured and another visit set up for this event.
The third study event is the 2 week follow up. During the visit the subject will fill in the 2 week follow up instrument and the Retrofitting instrument, after retrofitting. Subject keeps using the investigational device.
The final study event, and expected fourth visit, is at 6 months post successful fitting. The subject fills in the 6 month follow up instrument, receives compensation as applicable and ends study participation.
The subjects will return the trial device at the 6 month visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: TPE LinerNew TPE liner: Subjects get a new socket and are fitted with a new liner under development. Subjects use the liner for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPE LinerSubjects 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. | Device | Treatment Group |
Primary outcome
Perceived Suspension Quality Score
Time frame: 2 weeks
Suspension Score: Suspension quality was assessed using an in-house developed questionnaire consisting of 7 items evaluating perceived prosthetic suspension and security throughout the day. The items assessed stability in the socket, suspension in the morning, afternoon, and evening, vertical movement (pistoning), rotational movement, and the influence of perspiration on suspension. Each item was rated on a 10-cm Visual Analog Scale (VAS) ranging from 0 to 10. Depending on the item, 0 represented the poorest suspension outcome (e.g., completely disagree, extreme influence of perspiration) and 10 represented the best suspension outcome (e.g., completely agree, no influence of perspiration). Item scores were averaged to obtain an overall suspension score ranging from 0 to 10, with higher scores indicating better perceived suspension quality and security.
Residual Limb Health Subscale Score (Average of 6 Items)
Time frame: 2 weeks
Residual Limb Health Subscale Score (average of 6 items). Residual limb health was assessed using the Prosthetic Evaluation Questionnaire - Residual Limb Health (PEQ-RLH) subscale, which evaluates sweating, odor, swelling, rashes, ingrown hairs, and sores or blisters on the residual limb. Participants rated each item on a 10-cm Visual Analog Scale (VAS) ranging from 0 to 10, where 0 represents the poorest residual limb health (most severe symptoms) and 10 represents the best residual limb health (no symptoms). The overall PEQ-RLH score was calculated as the mean of the six item scores, resulting in a total score ranging from 0 to 10. Higher scores indicate better residual limb health and fewer skin-related problems.
Number of Subjects That Drop Out Because of Dissatisfaction With the Liner (Not Socket Related).
Time frame: 6 months
Number of participants who discontinued study participation because of dissatisfaction with the investigational liner, excluding discontinuations related to socket fit or socket-related issues. Lower values indicate better user acceptance of the investigational liner.
2 secondary outcomes
Socket Fit Comfort VAS Score
Time frame: 2 weeks
Participants Able to Use the Trial Liner as Their Primary Prosthesis
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Pratt, CPO principal investigator
Össur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TPE Liner in people with Amputation Stumps, run by Össur Iceland ehf at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Suspension Quality Score (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.