Trials / Completed
CompletedNCT05925712
Aerofit Post Market Investigation
Evaluation of the Clinical Benefits of a Ventilating Suspension Interface for Individuals With Transfemoral Amputation, a Randomized Controlled Cross-over Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Össur Iceland ehf · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AeroFit Seal-In Liner / Socket | Össur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket. |
| DEVICE | Seal-In Silicone Liner | Seal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system. |
Timeline
- Start date
- 2023-06-06
- Primary completion
- 2024-05-31
- Completion
- 2024-05-31
- First posted
- 2023-06-29
- Last updated
- 2024-10-08
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05925712. Inclusion in this directory is not an endorsement.