Amputation, Skin Health, Transfemoral Amputation
Conditions
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.
Interventions
DEVICEAeroFit Seal-In Liner / Socket
Össur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket.
DEVICESeal-In Silicone Liner
Seal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system.
Sponsors
Össur Iceland ehf
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
Countries
United States
Outcome results
None listed