Clinical trial NCT05925712: Aerofit Post Market Investigation
Official title: Evaluation of the Clinical Benefits of a Ventilating Suspension Interface for Individuals With Transfemoral Amputation, a Randomized Controlled Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transfemoral Amputation
Amputation
Skin Health
Lead sponsor: Össur Iceland ehf
Sponsor class: INDUSTRY
First posted: 2023-06-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Subject perceived skin health (PEQ-RLH)
timeFrame: 4 weeks
Secondary outcomes:
measure: Subject perceived activity restriction and prosthesis use, TAPES-R
timeFrame: 4 weeks
measure: Subject perceived quality of life EQ-5D-5L
timeFrame: 4 weeks
measure: Incidents of prosthesis slippage, the need to remove liner to dry limb or liner and incidents of complete loss of suspension.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Gainesville Prosthetics
state: Florida
city: Indianapolis
country: United States
facility: NuTech Institute LLC
state: Indiana
city: Indianapolis
country: United States
facility: SRT Prosthetics & Orthotics NPC
state: Indiana
city: Bay City
country: United States
facility: Oakland Orthopedic
state: Michigan
city: Perrysburg
country: United States
facility: Perry Prosthetics
state: Ohio
city: Arlington
country: United States
facility: Baker Orthotics and Prosthetics
state: Texas
city: Virginia Beach
country: United States
facility: Reach Orthotics and Prosthetics Services
state: Virginia
Study officials:
References: