An interventional study of Iceform liner and sleeve in Prosthesis Failure, sponsored by Össur Iceland ehf. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Össur Iceland ehf (part of Embla Medical hf.) · Not applicable, Interventional, and Supportive care
Durability evaluation of a new material blend in the Iceform liner and Iceform sleeve.
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.
119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.
This study's enrollment of 64 is above the median of 36 across 69 interventional studies indexed under Prosthesis Failure.
Browse Prosthesis Failure studies →Össur Iceland ehf is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
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Exclusion Criteria:
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.
Device: Iceform liner and sleeve
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.
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.
Time frame: 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.
Time frame: 6 months
| Milestone | Failure Time Analysis |
|---|---|
| Started | 64 |
| Completed | 30 |
| Not completed | 34 |
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.
| Liners | Failure Time Analysis |
|---|---|
| Number of Liners With TPE Material Failure | 0 ± 0 |
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.
| Liners | Failure Time Analysis |
|---|---|
| Number of Liners With TPE Material Failure | 0 ± 0 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Failure Time Analysis | 0/64 (0%) | 0/64 (0%) | 7/64 (10.9%) |
| Event | Failure Time Analysis |
|---|---|
| Blisters and soresSkin and subcutaneous tissue disorders | 7/64 |
| Age, Continuous(years) | Failure Time Analysis |
|---|---|
| Median | 61 (50.2 to 65.0) |
| Sex: Female, Male(Participants) | Failure Time Analysis |
|---|---|
| Female | 25 |
| Male | 39 |
| Race and Ethnicity Not Collected(Participants) | Failure Time Analysis |
|---|
| Region of Enrollment(participants) | Failure Time Analysis |
|---|---|
| United States | 64 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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