At a glance
ClinicalIndex Comparison RecordN/ACompleted· 11 enrolled
Drug / intervention
Navii Kneedevice
Likely dose
Navii Knee (microprocessor-controlled prosthetic knee)AI-extracted
Key inclusion· 5
- ✓Unilateral transfemoral or knee disarticulation amputees who are regular prosthesis users for at least 3 months
- ✓Current microprocessor-controlled knee (passive only) users regularly performing stair and ramp descent activities
- ✓Age 18 years or older
- ✓Body weight between 45 kg and 136 kg
Key exclusion· 6
- ✕Users with stump pain
- ✕Users with socket problems
- ✕Pregnant users
- ✕Users with prosthetic knees other than passive MPKs (Power Knee, Kenevo, or mechanical knees)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Investigation on Performance of a New Developed Prosthetic Knee
In Brief
A clinical study evaluating Navii Knee for Amputation. Completed, enrolled 11 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmputation
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20252026
Enrollment StartFeb 2024
Primary CompletionMar 2024
First PostedDec 2024
TodayJul 2026
First PostedDec 27, 2024
Enrollment StartFeb 26, 2024
Primary CompletionMar 28, 2024
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 1.5 years ago
Interventions
Navii Kneedevice
Microprocessor controlled prosthetic knee (MPK)