N/A
N=11
Clinical Investigation (Beta) of a New Developed Prosthetic Knee
Amputation
Bottom Line
View on ClinicalTrials.gov: NCT06748729 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Satisfaction on Ramp Descent With the New Microprocessor-controlled Prosthetic Knee (MPK) — 1; 0; 3; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Navii Knee (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Össur Iceland ehf
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Satisfaction on Ramp Descent With the New Microprocessor-controlled Prosthetic Knee (MPK) |
1; 0; 3; 4; 1; 1 | — |
| PRIMARY Satisfaction on Stair Descent With the New Microprocessor-controlled Prosthetic Knee (MPK) |
0; 1; 3; 5; 0; 1 | — |
| PRIMARY Satisfaction on Level Ground Walking Activity |
0; 4; 0; 0; 6; 0 | — |
| PRIMARY Change in Overall Satisfaction From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use |
2.6; 7.4; 5.5 | — |
| PRIMARY Change in Distance Walked During 2-Minute Walk Test (2MWT) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use |
2.43; -1.8; -0.1 | — |
| PRIMARY Change in Time for the Timed Up and Go Test (TUG) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use |
-0.1; -0.2; -0.2 | — |
| PRIMARY Change in T-score for the Prosthetic Limb Users Survey of Mobility (PLUS-M) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use |
3.8; 20.0; 13.5 | — |
| PRIMARY Change in Activities-Specific Balance Confidence Score (ABC) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use |
2.3; 5.4; 4.1 | — |
Summary
The aim of this investigation is to evaluate the efficacy of the investigational device regarding performance improvements and satisfaction in descending activities for moderate to high active prosthesis users within the intended population for the investigational device. Additionally, the overall satisfaction for activities of daily living will be evaluated after a certain time of use (4 weeks home use).
Eligibility Criteria
Inclusion Criteria
- 45Kg< body weight < 136Kg
- Cognitive ability to understand all instructions and questionnaires in the study;
- Unilateral TF/KD amputees that are regular prosthesis users for at least 3 months
- Current MPK users (passive MPKs only) regularly performing descent activities (stairs/ramps)
- Age ≥ 18 years
- Willing and able to participate in the study and follow the protocol
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 Navii setup, as described in Instructions for use.
- Osseointegration
Data sourced from ClinicalTrials.gov (NCT06748729). 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.