IceExplore TF Liner Alpha Investigation

NCT04787484 | Completed Results

• 1 other identifier: CIP2019112674
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

Single group prospective repeated measures comparing breathable liner and breathable socket to conventional enclosed silicone liner and socket system. IceExploreTF liner, the investigational device, is intended to function as part of a system that replaces a missing limb, a prosthetic interface with suction suspension technology and force transmission properties. More specifically, it is intended to reduce the skin humidity associated with the closed environment of predicate liners whilst maintaining secure suspension and user comfort. The literature indicates that the impact of sweat and heat on quality of life for trans-femoral amputees is significant and actions to improve sweat and heat issues with the prosthesis can contribute substantially to the well-being of amputees and could additionally have a positive effect on residual limb skin health.

Conditions

Prostheses and Implants

Keywords

prosthesis; amputee; trans-femoral; liner; seal; silicone; sweat; moisture

Outcome Measures

Primary Outcomes (2)

• The Average Perceived Socket Suspension Score at 12 Weeks Equal or Above 72%

  The Comprehensive Lower Limb Amputee Socket Survey (CLASS) is a patient-reported outcome measure designed to assess satisfaction with a prosthetic socket across four domains: suspension, stability, comfort, and appearance. Items are rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with 0 indicating that an item is not applicable. In this study, the CLASS Suspension subscale was used to evaluate participants' perceived security of prosthetic suspension. Participants rated the security of suspension during four activities: sitting, standing, walking, and ascending or descending stairs. The ratings for all activities were summed and divided by 16, the maximum possible score, to generate a normalized suspension score, with higher scores indicating greater perceived suspension security. The resulting value was multiplied by 100 and reported as a percentage score ranging from 25-100, where higher scores indicate better perceived suspension.

  12 weeks

• Difference in Average Perceived Moisture on Skin With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks Compared to Össur seal-in Silicone Liners and Direct Socket TF

  PEQ item Q is one question from Prosthetic Evaluation Questionnaire (PEQ) - "Over the past four weeks rate how much you sweat inside your prosthesis (in the sock, liner, socket)". A self-reported measure on a scale from 1-10 were 1 is extreme amount of sweat and 10 is no sweat at all.

  12 weeks

Secondary Outcomes (5)

• Difference in Average Perceived Skin Health With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF

  12 weeks

• Difference in Average Perceived Comfort With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF

  12 weeks

• Difference in Average Perceived Stability During Increased Perspiration With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF

  12 weeks

• Difference in Average Perceived Suspension During Increased Perspiration With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF

  12 weeks

• Difference in Average Perceived Hygiene With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks Compared to Össur seal-in Silicone Liners and Direct Socket TF

  12 weeks

Study Arms (1)

IceExplore TF breathable liner and Direct Socket drilled with holes for additional breathability

EXPERIMENTAL

The primary objective of this investigation will be to evaluate perceived secure suspension and perceived moisture on skin. The secondary objective will be to evaluate subjects skin health and perceived comfort. Thirdly, to evaluate perceived stability and suspension during increased perspiration and hygiene. Additionally, usability parameters will be explored, both for amputees and CPOs. Amputees usability such as inverting liner, donning/doffing liner and socket, ease of cleaning the liner, number of instances that the user dons/doffs socket per one day and general user satisfaction of the amputee will be explored. Subjects mobility will be evaluated between comparator (baseline) and investigational device with the use of PLUS-M (Prosthetic Limb Users Survey of Mobility).

Device: IceExplore TF breathable liner and Direct Socket drilled with holes

Interventions

IceExplore TF breathable liner and Direct Socket drilled with holes DEVICE

The IceExplore TF liners are similar in intended use, methods of operation and materials to other seal-in TF silicone liners manufactured by Össur. The main difference is that the internal structure of the predicate liner is formed entirely of airtight silicone whereas the proximal 70% (approx.) of the IceExplore TF liner consists of a breathable structure, allowing water vapor to move both transversely away from the skin and longitudinally towards the proximal edge of the prosthetic socket. The investigational device is a part of a prosthesis system targeted for users with lower extremity amputation (trans-femoral amputees), physically fit for using a prosthesis to replace the function of an amputated lower limb.

IceExplore TF breathable liner and Direct Socket drilled with holes for additional breathability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kg\< body weight \< 136Kg
• Cognitive ability to understand all instructions and questionnaires in the study
• Unilateral/bilateral trans-femoral amputees
• Activity level: high K2-K4
• Liner: Össur Seal-In TF silicone liner
• Socket: All subjects shall be using Direct Socket, and have been for minimum 4 weeks
• Willing and able to participate in the study and follow the protocol
• Confident prosthetic users for more than 3 months
• Older than 18 years
• Residual limb profile: Standard or conical. At least 30% of subjects must be either conical or standard.

You may not qualify if:

• Kg\> body weight \> 136Kg
• Users with cognitive impairment
• Participating in another research study

Sponsors & Collaborators

• Össur Iceland ehf: lead

Results Point of Contact

• Title: Clinical evaluation and investigation specialist
• Organization: Össur Iceland ehf.

medicaloffice@ossur.com

+354 515 1300

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: March 8, 2021
• Study Start: October 5, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: September 4, 2026
• Results First Posted: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share