Aerofit Post Market Investigation

Not Applicable

Completed

• Conditions: Transfemoral Amputation; Skin Health; Amputation
• Interventions: Device: AeroFit Seal-In Liner / Socket; Device: Seal-In Silicone Liner

• Registration Number: NCT05925712
• Lead Sponsor: Össur Ehf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-31
• Study Start: 2023-06-06
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-06-29
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Crossover BAB	Seal-In Silicone Liner	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.
Crossover ABA	Seal-In Silicone Liner	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.
Crossover BAB	AeroFit Seal-In Liner / Socket	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.
Crossover ABA	AeroFit Seal-In Liner / Socket	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.

Primary Outcome Measures

Name	Time	Method
Subject perceived skin health (PEQ-RLH)	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 Outcome Measures

Name	Time	Method
Subject perceived activity restriction and prosthesis use, TAPES-R	4 weeks	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
Subject perceived quality of life EQ-5D-5L	4 weeks	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
Incidents of prosthesis slippage, the need to remove liner to dry limb or liner and incidents of complete loss of suspension.	4 weeks	Self-report: In-house generated questionnaire on prosthesis slippage and the need to remove prosthesis due to moisture .; Higher score means worse slippage experience.

Trial Locations

Locations (7)

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

Perry Prosthetics; 🇺🇸 Perrysburg, Ohio, United States

Baker Orthotics and Prosthetics; 🇺🇸 Arlington, Texas, United States

Reach Orthotics and Prosthetics Services; 🇺🇸 Virginia Beach, Virginia, United States