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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover ABA | Experimental | 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. |
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| Crossover BAB | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AeroFit Seal-In Liner / Socket | Device | Össur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject perceived skin health (PEQ-RLH) | PEQ-RLH (Prosthesis Evaluation Questionnaire - Residual Limb Health) Questionnaire Mean of six 1-10 point scale items, higher score indicates better RLH | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subject perceived activity restriction and prosthesis use, TAPES-R | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gainesville Prosthetics | Gainesville | Florida | 32606 | United States | ||
| NuTech Institute LLC |
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| Seal-In Silicone Liner | Device | Seal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system. |
|
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. | 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 |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| SRT Prosthetics & Orthotics NPC | Indianapolis | Indiana | 46202 | United States |
| Oakland Orthopedic | Bay City | Michigan | 48708 | United States |
| Perry Prosthetics | Perrysburg | Ohio | 43551 | United States |
| Baker Orthotics and Prosthetics | Arlington | Texas | 76015 | United States |
| Reach Orthotics and Prosthetics Services | Virginia Beach | Virginia | 23452 | United States |