N/A
N=17
Clinical Investigation (Beta) of Power Knee Mainstream - Dynamic
Prosthesis User · Amputation
Bottom Line
View on ClinicalTrials.gov: NCT04787627 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Mean Difference in Borg Category Rating Scale Before and After 6MWT at 2 Weeks — 3.4; 2.8; 3.1; 2.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Power Knee (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Össur Iceland ehf
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Difference in Borg Category Rating Scale Before and After 6MWT at 2 Weeks |
3.4; 2.8; 3.1; 2.5; 3.4; 3.3 | — |
| PRIMARY Average Distance Walked in 6 Minute Walk Test |
381.7; 402.5; 377.2; 390.7; 369.2; 381.5 | — |
| SECONDARY Total Score of Prosthesis Mobility Questionnaire (PMQ) Questions 9 and 10 |
6.8; 7.2; 5.8; 5.7; 5.6; 6.0 | — |
| SECONDARY Average Score of Modified Prosthesis Evaluation Questionnaire (PEQ) Question 14F |
7.9; 8.3; 7.1; 6.8; 7.3; 6.8 | — |
| SECONDARY Average Score of Modified Prosthesis Evaluation Questionnaire (PEQ) Question 13D |
9.2; 9.5; 7.8; 7.2; 7.7; 7.7 | — |
| SECONDARY Satisfaction With Walking Speed |
100; 100 | — |
| SECONDARY Prosthetic Limb Users Survey of Mobility (PLUS-M) T-score |
57.2; 57.9; 51.7; 51.9; 53.1; 54.1 | — |
| SECONDARY Average Score of Modified Prosthesis Evaluation Questionnaire (PEQ) Question 13A |
8.4; 9.0; 8.5; 8.3; 8.6; 8.7 | — |
| SECONDARY Average Score of Prosthesis Evaluation Questionnaire (PEQ) Question 1D |
9.0; 9.5; 8.5; 8.0; 8.6; 8.3 | — |
| SECONDARY Average Score Regarding the Ease of Setup |
9.0; 6.5; 8.6 | — |
| SECONDARY Proportion of Participants With Average Score Over 5 on Questions 3K and 3L of the Prosthesis Evaluation Questionnaire (PEQ) With the Investigational Device |
72 | — |
| SECONDARY Total Score of Prosthesis Mobility Questionnaire (PMQ) Questions 1 and 3-6: |
15.6; 16.7; 14.2; 13.3; 13.8; 13.2 | — |
| SECONDARY Time Required to Complete the L-test |
26.3; 25.2; 24.2; 23.8; 23.7; 23.0 | — |
| SECONDARY Average Prosthetic Mobility Questionnaire (PMQ) Total Score |
35.5; 37.3; 31.2; 29.8; 31.5; 31.5 | — |
| SECONDARY Occurrence of Side Effects That Could be Directly Related to Using the Power Knee |
— | — |
Summary
Prospective two group cross over investigation, comparing the investigational device (Power Knee, a powered microprocessor controlled prosthetic knee) and subjects prescribed microprocessor prosthetic knee (MPK).
The primary objective was to evaluate the efficacy of the investigational device in reducing exertion during walking compared to passive MPKs. Additionally to evaluate the efficacy of the investigational device in the short and long term compared to passive MPKs and previous versions of the Power Knee, during daily living activities i.e. walking on level ground, in stairs and inclines, rising from and sitting down to a chair as well as performance of gait functions and ease of set up for average to highly active transfemoral/knee disarticulation amputees and Certified Prosthetists/Orthotists (CPOs).
Eligibility Criteria
Inclusion Criteria
- 50Kg body weight > 116Kg
- Bilateral amputees
- Users with socket problems
- Users with co-morbidities in the contra-lateral limb, which affect their functional mobility
- Younger than 18 years old
- Users with stump pain
- Users with cognitive impairment
- Users not involved in other clinical tests and/or receiving treatment that the testing might affect.
Data sourced from ClinicalTrials.gov (NCT04787627). 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.