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OpenTrials
Completed

NCT Number: NCT05925712

Aerofit Post Market Investigation

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.

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Key information

Conditions

Transfemoral Amputation Amputation Skin Health

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gainesville Prosthetics, Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AeroFit Seal-In Liner / Socket

Device

Össur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket.

Seal-In Silicone Liner

Device

Seal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Össur Iceland ehf

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 29, 2023
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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