Prosthesis FailureNCT05040165
Investigation on Failure Time Analysis of a New TPE Material in the Iceform Liner
A study testing Iceform liner and sleeve in people with Prosthesis Failure, run by Össur Iceland ehf at 1 site in United States.
Trial summary
Durability evaluation of a new material blend in the Iceform liner and Iceform sleeve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthesis Failure
- What is being tested?
- Iceform liner and sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2019to 30 Aug 2020
- 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
- Trans-tibial amputee
- Uses an Iceform or Willow Wood Alpha Classic (Uniform profile) 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
- Participating in another research study
- Participants of another research study during previous 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Durability evaluation of a new material blend in the Iceform liner and Iceform sleeve.
Read the detailed description
Potential subjects will be identified from the customer base of a relevant clinic. If a potential participant may fit the inclusion and exclusion criteria, he/she will be contacted by a Co-Investigator (CI) via telephone. During the telephone call the CI will verify if they are interested in participating in a study and will initiate the enrollment procedure. If interest is expressed at this point they will answer some screening questions and if the eligibility criteria is met the subject is offered to enroll by getting a study invite through ProofPilot, the EDS, and an appointment to come in for initial fitting will be set up. Questions relating to the duration of the study, number of clinical visits required, and the investigational device will be answered at this time.
Following this the subject will log into ProofPilot online and go through the e-ICF, if signed, the subject will answer a profile questionnaire.
The next step will be an appointment, subject comes into their clinic and gets the investigational device. In some cases, the subject will get the liner shipped to their home address. This will only be done upon subjects request due to long distance from clinic. And only for very confident prosthetic users which are used to handle a new liner by themselves.
Potential risk of participating in the investigation will be explained to the subject at this point. The CIs will communicate to the study monitors the number of users that have been identified that meet the inclusion/exclusion criteria and are willing to participate.
During the clinical visit the subjects will only be fitted to the Iceform investigational liner. Profile and relevant contact information will already have been collected via the EDS.
Subjects will then receive a prompt monthly, either via email, SMS or smartphone notification, to fill in the EDS questionnaire, and perform any tasks as applicable. If a subject reports a failure he/she will be instructed to stop using the liner, the remaining gift cards will be delivered and their participation ends. Otherwise, participation will end at 6 months.
The subject gets to keep the investigational device at the end of the study, therefore there is no need for an additional visit.
Subjects that report a failure of the TPE material may be contacted by the Coordinating Investigator or CI if the root cause of the failure cannot be confidently determined from the data collected with the EDS system.
- Conditions
- Prosthesis Failure
- Being tested
- Iceform liner and sleeve
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iceform liner and sleeveDevice
Subjects will be asked to use the investigational device as their primary prosthesis for up to 6 months. TPE material durability evaluated through monthly online questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Failure time analysis | Experimental | The primary objective is to evaluate the durability of the investigational device over its intended use lifetime (i.e. warranty period), specifically relating to any defect in the TPE material. Additionally, to gather information on the rate of side-effects, i.e. skin rashes, sores, etc.
Secondary objectives relate to gather information on how amputees use the liner, specifically:
* Intensity of use (days/week and hours/day)
* Alternation; i.e. switching every other day between liners
* Use of personal hygiene or cosmetic products
The following performance and safety aspects are to be verified:
• The ICEFORM line of devices are durable over their intended use lifetime. Receives: Device: Iceform liner and sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Liners With TPE Material Failure
Number of study liners that experienced TPE material failure by the specified time point. TPE material failure was defined as any defect, cracking, tearing, or other failure of the thermoplastic elastomer material.
Measured: 3 months
Number of Liners With TPE Material Failure
Number of study liners that experienced TPE material failure by the specified time point. TPE material failure was defined as any defect, cracking, tearing, or other failure of the thermoplastic elastomer material.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start8 Dec 2019
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
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 Prosthesis FailureStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Justin L Pratt, CP, Principal investigator, Össur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040165
- Sponsor's protocol ID
- CIP2019052102
- Status last verified
- Sep 2021
- First submitted
- 18 Nov 2020
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Failure Time Analysis of a New TPE Material in the Iceform Liner
- ClinicalTrials.gov ID
- NCT05040165
- Acronym / sponsor ID
- CIP2019052102
- Conditions
- Prosthesis Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Posted 20 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Durability evaluation of a new material blend in the Iceform liner and Iceform sleeve.
Detailed description
Potential subjects will be identified from the customer base of a relevant clinic. If a potential participant may fit the inclusion and exclusion criteria, he/she will be contacted by a Co-Investigator (CI) via telephone. During the telephone call the CI will verify if they are interested in participating in a study and will initiate the enrollment procedure. If interest is expressed at this point they will answer some screening questions and if the eligibility criteria is met the subject is offered to enroll by getting a study invite through ProofPilot, the EDS, and an appointment to come in for initial fitting will be set up. Questions relating to the duration of the study, number of clinical visits required, and the investigational device will be answered at this time.
Following this the subject will log into ProofPilot online and go through the e-ICF, if signed, the subject will answer a profile questionnaire.
The next step will be an appointment, subject comes into their clinic and gets the investigational device. In some cases, the subject will get the liner shipped to their home address. This will only be done upon subjects request due to long distance from clinic. And only for very confident prosthetic users which are used to handle a new liner by themselves.
Potential risk of participating in the investigation will be explained to the subject at this point. The CIs will communicate to the study monitors the number of users that have been identified that meet the inclusion/exclusion criteria and are willing to participate.
During the clinical visit the subjects will only be fitted to the Iceform investigational liner. Profile and relevant contact information will already have been collected via the EDS.
Subjects will then receive a prompt monthly, either via email, SMS or smartphone notification, to fill in the EDS questionnaire, and perform any tasks as applicable. If a subject reports a failure he/she will be instructed to stop using the liner, the remaining gift cards will be delivered and their participation ends. Otherwise, participation will end at 6 months.
The subject gets to keep the investigational device at the end of the study, therefore there is no need for an additional visit.
Subjects that report a failure of the TPE material may be contacted by the Coordinating Investigator or CI if the root cause of the failure cannot be confidently determined from the data collected with the EDS system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Failure time analysis | Experimental | Device: Iceform liner and sleeveThe primary objective is to evaluate the durability of the investigational device over its intended use lifetime (i.e. warranty period), specifically relating to any defect in the TPE material. Additionally, to gather information on the rate of side-effects, i.e. skin rashes, sores, etc. Secondary objectives relate to gather information on how amputees use the liner, specifically: * Intensity of use (days/week and hours/day) * Alternation; i.e. switching every other day between liners * Use of personal hygiene or cosmetic products The following performance and safety aspects are to be verified: • The ICEFORM line of devices are durable over their intended use lifetime. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Trans-tibial amputee
- Uses an Iceform or Willow Wood Alpha Classic (Uniform profile) 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
Key exclusion criteria (2 listed)
- Participating in another research study
- Participants of another research study during previous 2 months.
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 |
|---|---|---|
| Iceform liner and sleeveSubjects will be asked to use the investigational device as their primary prosthesis for up to 6 months. TPE material durability evaluated through monthly online questionnaires. | Device | Failure time analysis |
Primary outcome
Number of Liners With TPE Material Failure
Time frame: 3 months
Number of study liners that experienced TPE material failure by the specified time point. TPE material failure was defined as any defect, cracking, tearing, or other failure of the thermoplastic elastomer material.
Number of Liners With TPE Material Failure
Time frame: 6 months
Number of study liners that experienced TPE material failure by the specified time point. TPE material failure was defined as any defect, cracking, tearing, or other failure of the thermoplastic elastomer material.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 L Pratt, CP 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 Iceform liner and sleeve in people with Prosthesis Failure, 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 5 inclusion and 2 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 20 Aug 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 20 Aug 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?
Number of Liners With TPE Material Failure (time frame: 3 months). The study lists 2 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 20 Aug 2026.