Aerofit Post Market Investigation

Össur

Status: Completed

Conditions: Skin Health; Transfemoral Amputation; Amputation

Treatments: Device: AeroFit Seal-In Liner / Socket; Device: Seal-In Silicone Liner

Study type: Interventional

Funder types: Industry

Identifiers

NCT05925712

CIP2022020161

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Crossover ABA

Experimental group

Description:

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.

Treatment:

Device: Seal-In Silicone Liner

Device: AeroFit Seal-In Liner / Socket

Crossover BAB

Experimental group

Description:

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.

Treatment:

Device: Seal-In Silicone Liner

Device: AeroFit Seal-In Liner / Socket