NCT06748729

Clinical Investigation (Beta) of a New Developed Prosthetic Knee

Investigation on Performance of a New Developed Prosthetic Knee

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Össur Iceland ehf · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This investigation is a non-randomized single group repeated measures open label prospective design with observational and self-report measures. Two scheduled study events are planned for amputee subjects, with 4 weeks between visits.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	Navii Knee	Microprocessor controlled prosthetic knee (MPK)

Timeline

• Start date: 2024-02-26
• Primary completion: 2024-03-28
• Completion: 2024-03-28
• First posted: 2024-12-27
• Last updated: 2025-09-04
• Results posted: 2025-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study