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Aerofit Post Market Investigation

Sponsor
Össur Ehf (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05925712
Collaborator
(none)
60
Enrollment
5
Locations
2
Arms
7.9
Anticipated Duration (Months)
12
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: AeroFit Seal-In Liner / Socket
  • Device: Seal-In Silicone Liner
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Clinical Benefits of a Ventilating Suspension Interface for Individuals With Transfemoral Amputation, a Randomized Controlled Cross-over Trial
Actual Study Start Date :
Jun 6, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gainesville Prosthetics Gainesville Florida United States 32606
2 SRT Prosthetics & Orthotics NPC Indianapolis Indiana United States 46202
3 Oakland Orthopedic Bay City Michigan United States 48708
4 Perry Prosthetics Perrysburg Ohio United States 43551
5 Baker Orthotics and Prosthetics Arlington Texas United States 76015

Sponsors and Collaborators

  • Össur Ehf

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Össur Ehf
ClinicalTrials.gov Identifier:
NCT05925712
Other Study ID Numbers:
  • CIP2022020161
First Posted:
Jun 29, 2023
Last Update Posted:
Jun 29, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Jun 29, 2023