Aerofit Post Market Investigation

Study Overview
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Brief Summary
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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.

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

Conditions
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Transfemoral Amputation, Amputation, Skin Health

Intervention / Treatment
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* Device: AeroFit Seal-In Liner / Socket
* Device: Seal-In Silicone Liner


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crossover ABA<br>Group 1 starts using the ventilating suspension system (condition A), group 2 starts using non-ventilating suspension system (condition B) and then they cross-over to the other system, two times. | Device: AeroFit Seal-In Liner / Socket<br>* Össur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket.<br>Device: Seal-In Silicone Liner<br>* Seal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system.<br>|
| Experimental: Crossover BAB<br>Group 1 starts using the ventilating suspension system (condition A), group 2 starts using non-ventilating suspension system (condition B) and then they cross-over to the other system, two times. | Device: AeroFit Seal-In Liner / Socket<br>* Össur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket.<br>Device: Seal-In Silicone Liner<br>* Seal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 4 weeks |