Aerofit Post Market Investigation
Completed · Not applicable
Conditions studied: Transfemoral Amputation, Amputation, Skin Health
In brief
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.
Key facts
- Study ID
- NCT05925712
- Run by
- Össur Iceland ehf
- People needed
- 56
- Starts
- 2023-06-06
- Expected to finish
- 2024-05-31
- Last updated by the study team
- 2024-10-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Gainesville Prosthetics — Gainesville, Florida, United States
- NuTech Institute LLC — Indianapolis, Indiana, United States
- SRT Prosthetics & Orthotics NPC — Indianapolis, Indiana, United States
- Oakland Orthopedic — Bay City, Michigan, United States
- Perry Prosthetics — Perrysburg, Ohio, United States
- Baker Orthotics and Prosthetics — Arlington, Texas, United States
- Reach Orthotics and Prosthetics Services — Virginia Beach, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.