Aerofit Post Market Investigation

November 23, 2023 updated by: Össur Ehf

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32606
        • Completed
        • Gainesville Prosthetics
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • SRT Prosthetics & Orthotics NPC
        • Contact:
      • Indianapolis, Indiana, United States, 46202
    • Michigan
      • Bay City, Michigan, United States, 48708
        • Completed
        • Oakland Orthopedic
    • Ohio
      • Perrysburg, Ohio, United States, 43551
        • Completed
        • Perry Prosthetics
    • Texas
      • Arlington, Texas, United States, 76015
    • Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject perceived skin health (PEQ-RLH)
Time Frame: 4 weeks
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
Time Frame: 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
4 weeks
Subject perceived quality of life EQ-5D-5L
Time Frame: 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
4 weeks
Incidents of prosthesis slippage, the need to remove liner to dry limb or liner and incidents of complete loss of suspension.
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Össur Ehf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2023

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CIP2022020161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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