Aerofit Post Market Investigation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2024-05-31

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.

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Detailed Description

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Conditions

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Transfemoral Amputation Amputation Skin Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crossover ABA

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.

Group Type EXPERIMENTAL

AeroFit Seal-In Liner / Socket

Intervention Type DEVICE

Össur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket.

Seal-In Silicone Liner

Intervention Type DEVICE

Seal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system.

Crossover BAB

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.

Group Type EXPERIMENTAL

AeroFit Seal-In Liner / Socket

Intervention Type DEVICE

Össur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket.

Seal-In Silicone Liner

Intervention Type DEVICE

Seal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system.

Interventions

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AeroFit Seal-In Liner / Socket

Össur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket.

Intervention Type DEVICE

Seal-In Silicone Liner

Seal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No