N/A
N=14
An Investigation on Function and Performance of a New Microprocessor Controlled Prosthetic Knee
Prosthesis User · Amputation
Bottom Line
View on ClinicalTrials.gov: NCT05523349 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Satisfaction During Stair Descent — 0.80 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NAVii (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Össur Iceland ehf
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Satisfaction During Stair Descent |
0.80 | — |
| SECONDARY Six Minute Walk Test |
326.8; 326.7 | — |
Summary
This investigation aims to compare the functional performance of a new passive microprocessor-controlled Prosthetic Knee to subjects usual microprocessor-controlled prosthetic knee.
Eligibility Criteria
Inclusion Criteria
- 45Kg 4021)
Exclusion Criteria
- Users with stump pain
- Users with socket problems
- Pregnant Users
- Users using Power Knee, Kenevo or mechanical knees as their prescribed prosthesis
- Alignment that cannot be matched with the Rheo Knee 4 setup, as described in Instructions for use.
- Osseointegration
Data sourced from ClinicalTrials.gov (NCT05523349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.