Clinical Investigation (Beta) of a New Developed Prosthetic Knee

Össur Iceland ehf

Status: Completed

Conditions: Amputation

Treatments: Device: Navii Knee

Study type: Interventional

Funder types: Industry

Identifiers

NCT06748729

CIP2023120529

Details and patient eligibility

About

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).

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Exploratory testing of a new prosthetic knee

Experimental group

Description:

The investigational device is provided to subjects, who then use it as their main prosthesis for a period of 4 weeks prior to returning for data collection on the device.

Treatment:

Device: Navii Knee