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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Össur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket.
Seal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system.
Gainesville Prosthetics
Gainesville, Florida, United States
NuTech Institute LLC
Indianapolis, Indiana, United States
SRT Prosthetics & Orthotics NPC
Indianapolis, Indiana, United States
Oakland Orthopedic
Bay City, Michigan, United States
Subject perceived skin health (PEQ-RLH)
PEQ-RLH (Prosthesis Evaluation Questionnaire - Residual Limb Health) Questionnaire Mean of six 1-10 point scale items, higher score indicates better RLH
Time frame: 4 weeks
Subject perceived activity restriction and prosthesis use, TAPES-R
Self-report: TAPES-R (Trinity Amputation and Prosthesis Experiences Scales) - Activity Restriction scale Mean of ten 3-point scale items, higher score indicates less restriction
Time frame: 4 weeks
Subject perceived quality of life EQ-5D-5L
Self-report: EQ-5D-5L 5-level EQ-5D version (EQ-5D-5L) Use of AeroFit system provides non-inferior quality of life\* 0-1.00 index value, higher value indicates higher QALY
Time frame: 4 weeks
Incidents of prosthesis slippage, the need to remove liner to dry limb or liner and incidents of complete loss of suspension.
Self-report: In-house generated questionnaire on prosthesis slippage and the need to remove prosthesis due to moisture . Higher score means worse slippage experience.
Time frame: 4 weeks
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Perry Prosthetics
Perrysburg, Ohio, United States
Baker Orthotics and Prosthetics
Arlington, Texas, United States
Reach Orthotics and Prosthetics Services
Virginia Beach, Virginia, United States