Amputation Clinical Trial
Official title:
Evaluation of the Clinical Benefits of a Ventilating Suspension Interface for Individuals With Transfemoral Amputation, a Randomized Controlled Cross-over Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 30, 2024 |
Est. primary completion date | May 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Baker Orthotics and Prosthetics | Arlington | Texas |
United States | Oakland Orthopedic | Bay City | Michigan |
United States | Gainesville Prosthetics | Gainesville | Florida |
United States | NuTech Institute LLC | Indianapolis | Indiana |
United States | SRT Prosthetics & Orthotics NPC | Indianapolis | Indiana |
United States | Perry Prosthetics | Perrysburg | Ohio |
United States | Reach Orthotics and Prosthetics Services | Virginia Beach | Virginia |
Lead Sponsor | Collaborator |
---|---|
Össur Ehf |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Subject perceived quality of life EQ-5D-5L | 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 | |
Secondary | 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 |
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