Evaluation of the Clinical Benefits of a Ventilating Suspension Interface for Individuals With Transfemoral Amputation, a Randomized Controlled Cross-over Trial

Össur Ehf7 sites in 1 country56 target enrollmentJune 6, 2023

ConditionsTransfemoral Amputation Amputation Skin Health

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Transfemoral Amputation
Sponsor: Össur Ehf
Enrollment: 56
Locations: 7
Primary Endpoint: Subject perceived skin health (PEQ-RLH)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical investigation is to evaluate the clinical benefits of a ventilating suspension interface for individuals with transfemoral amputation. The main aim of the investigation will be to evaluate the clinical user-reported benefits to skin health from using a ventilating lower limb prosthetic suspension system and compare it to a non-ventilating suspension system.

Registry

clinicaltrials.gov

Start Date

June 6, 2023

End Date

May 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Össur Ehf

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•50Kg\< body weight \< 136Kg
•Cognitive ability to understand all instructions and questionnaires in the study
•Intended for unilateral/bilateral individuals that fit the indications for use, fit within the specified criteria and with the limb length, shape and ability to use a prosthetic liner: Activity level: K1 - K4, Impact level: Low to high, Amputation level: transfemoral
•Congenital transverse deficiency at femoral level
•Using Seal-In Silicone Liner and Direct Socket or AeroFit Seal-In Liner and AeroFit Socket
•Able to use AeroFit Solution, see Figure 7 AeroFit Seal-In Liner Sizes and Figure 8 Minimum socket height per liner profile.
•Residual limb profile: Standard or conical
•Willing and able to participate in the study and follow the protocol
•Confident (all day) prosthetic users for more than 3 months
•Older than 18 years

Exclusion Criteria

•Participating in another research study that may affect the participation or results of this study (in the opinion of the investigator)
•Users that have received Botox injection as treatment for residual limb sweat issue in the last 4 months

Outcomes

Primary Outcomes

Subject perceived skin health (PEQ-RLH)

Time Frame: 4 weeks

PEQ-RLH (Prosthesis Evaluation Questionnaire - Residual Limb Health) Questionnaire Mean of six 1-10 point scale items, higher score indicates better RLH

Secondary Outcomes

Subject perceived activity restriction and prosthesis use, TAPES-R(4 weeks)
Subject perceived quality of life EQ-5D-5L(4 weeks)
Incidents of prosthesis slippage, the need to remove liner to dry limb or liner and incidents of complete loss of suspension.(4 weeks)