Investigation Into the Functional Performance of a New Thermoplastic Elastomer (TPE) Transtibial Liner

NCT02622919 | Completed Results FDA Device

• 1 other identifier: CIP2015061050
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Amputation Stumps

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  6 months

Secondary Outcomes (2)

• Socket Fit Comfort VAS Score

  2 weeks

• Participants Able to Use the Trial Liner as Their Primary Prosthesis

  2 weeks

Other Outcomes (1)

• Satisfaction With Noise Generated During Prosthesis Use

  2 weeks

Study Arms (1)

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.

Device: TPE Liner

Interventions

TPE Liner DEVICE

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.

Treatment Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Össur Iceland ehf: lead

Study Sites (1)

Valley Institute of Prosthetics and Orthotics, Inc.

Bakersfield, California, 93301, United States

Location

Results Point of Contact

• Title: Clinical Investigation Specialist
• Organization: Ossur

medicaloffice@ossur.com

+3545151300

Study Officials

• Justin Pratt, CPO

  Össur

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 7, 2015
• Study Start: March 30, 2016
• Primary Completion: November 15, 2018
• Study Completion: January 30, 2019
• Last Updated: September 11, 2026
• Results First Posted: September 11, 2026

Record last verified: 2025-09

Locations

US (1)