Aerofit Post Market Investigation

Last updated: October 4, 2024
Sponsor: Össur Ehf
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

AeroFit Seal-In Liner / Socket

Seal-In Silicone Liner

Clinical Study ID

NCT05925712
CIP2022020161
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, fitwithin the specified criteria and with the limb length, shape and ability to use aprosthetic liner: Activity level: K1 - K4, Impact level: Low to high, Amputationlevel: transfemoral

  • Congenital transverse deficiency at femoral level

  • Using Seal-In Silicone Liner and Direct Socket or AeroFit Seal-In Liner and AeroFitSocket

  • Able to use AeroFit Solution, see Figure 7 AeroFit Seal-In Liner Sizes and Figure 8Minimum 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

Exclusion Criteria:

  • Participating in another research study that may affect the participation or resultsof this study (in the opinion of the investigator)

  • Users that have received Botox injection as treatment for residual limb sweat issuein the last 4 months

Study Design

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: AeroFit Seal-In Liner / Socket
Phase:
Study Start date:
June 06, 2023
Estimated Completion Date:
May 31, 2024

Connect with a study center

  • Gainesville Prosthetics

    Gainesville, Florida 32606
    United States

    Site Not Available

  • NuTech Institute LLC

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • SRT Prosthetics & Orthotics NPC

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Oakland Orthopedic

    Bay City, Michigan 48708
    United States

    Site Not Available

  • Perry Prosthetics

    Perrysburg, Ohio 43551
    United States

    Site Not Available

  • Baker Orthotics and Prosthetics

    Arlington, Texas 76015
    United States

    Site Not Available

  • Reach Orthotics and Prosthetics Services

    Virginia Beach, Virginia 23452
    United States

    Site Not Available

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