Aerofit Post Market Investigation

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05925712
• Other study ID #: CIP2022020161
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: November 2023
• Source: Össur Ehf
• Contact: Jóna V Kristjánsdottir, M.Sc
• Phone: +3545151300
• Email: medicaloffice[@]ossur.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Skin Health
• Transfemoral Amputation

Intervention

Device:
• AeroFit Seal-In Liner / Socket
Össur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket.
• Seal-In Silicone Liner
Seal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system.

Locations

Country	Name	City	State
United States	Baker Orthotics and Prosthetics	Arlington	Texas
United States	Oakland Orthopedic	Bay City	Michigan
United States	Gainesville Prosthetics	Gainesville	Florida
United States	NuTech Institute LLC	Indianapolis	Indiana
United States	SRT Prosthetics & Orthotics NPC	Indianapolis	Indiana
United States	Perry Prosthetics	Perrysburg	Ohio
United States	Reach Orthotics and Prosthetics Services	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Össur Ehf

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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