Investigation on a New Power Knee Firmware Update on Gait and Daily Life Activities for Transfemoral Amputees

January 14, 2026 updated by: Össur Iceland ehf

Investigation on a New Power Knee Firmware Update on Gait and Daily Life Activities, a Randomized Controlled Double-blinded Cross-over Investigation

The goal of this interventional study is to investigate a new firmware in development for Power Knee on gait and daily life activities in unilateral transfemoral amputees. The main question it aims to answer is:

What are the effects of a new firmware on sit-to-stand, level walking and stair ascent ?

Researchers will compare both a new and the current marketed firmware to see if there is any changes in performance.

Participants will be asked to perform some activities of daily living and some functional tests.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Bay City, Michigan, United States, 48708
        • Oakland Orthopedic Appliances Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 50 kg < body weight < 116 kg
  • lower limb loss, amputation or deficiency
  • cognitive ability to understand all instructions and questionnaires in the study
  • Unilateral transfemoral amputees that are regular Power Knee users for at least 4 weeks
  • age ≥ 18 years
  • Moderate to high active subjects
  • Willing and able to participate in the study and follow the protocol
  • Comfortable and stable socket fit
  • No socket issues/changes in the last 6 weeks

Exclusion Criteria:

  • Users with pain
  • Bilateral amputees
  • Users using passive microprocessor controlled knees
  • Users with cognitive impairment
  • Users with co-morbidities in the contra lateral limb, which affect their functional mobility
  • Hip disarticulation amputees
  • Users with osseointegrated prosthesis
  • Pregnant users

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A
Group A will start with the current marketed firmware.
Device: Power Knee Firmware Update
The firmware in development will be uploaded to the device.
Device: Power Knee Current Marketed Firmware
The current marketed firmware will be uploaded to the device.
Other: Group B
Group B will start with the firmware in development.
Device: Power Knee Firmware Update
The firmware in development will be uploaded to the device.
Device: Power Knee Current Marketed Firmware
The current marketed firmware will be uploaded to the device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sit to Stand Activity
Time Frame: after acclimatization at day 1 during the single study event
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing sit to stand activity
after acclimatization at day 1 during the single study event
Stand to Sit Activity
Time Frame: after acclimatization at day 1 during the single study event
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing stand to sit activity
after acclimatization at day 1 during the single study event
Level Ground Walking
Time Frame: after acclimatization at day 1 during the single study event
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing level ground walking.
after acclimatization at day 1 during the single study event

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
2MWT
Time Frame: after acclimatization at day 1 during the single study event
The 2-Minute Walk Test is a clinical assessment used to measure an individual's walking endurance and functional capacity. During the test, the participant is instructed to walk for 2 minutes at their comfortable pace along a marked course. The total distance walked within the 2-minute period is recorded (in meters).
after acclimatization at day 1 during the single study event
10mWT
Time Frame: after acclimatization at day 1 during the single study event
The 10-Meter Walk Test is a commonly used clinical assessment to measure an individual's walking speed over a short distance. During the test, the participant is asked to walk a distance of 10 meters at their fastest possible pace. The time taken to walk the 10 meters is recorded.
after acclimatization at day 1 during the single study event
Stair Ascent Activity
Time Frame: after acclimatization at day 1 during the single study event
Stair assessment index (0-13)
after acclimatization at day 1 during the single study event
Entering Stair Ascent Mode
Time Frame: after acclimatization at day 1 during the single study event
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing stair ascent (entering) activity
after acclimatization at day 1 during the single study event
Exiting From Stair Ascent Mode
Time Frame: after acclimatization at day 1 during the single study event
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing the stair ascent (exiting) activity.
after acclimatization at day 1 during the single study event
Perception of Stair Ascent Activity
Time Frame: after acclimatization at day 1 during the single study event
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing stair ascent activity
after acclimatization at day 1 during the single study event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Össur Iceland ehf

Investigators

  • Principal Investigator: Pete Simpson, Ossur Americas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2024

Primary Completion (Actual)

December 6, 2024

Study Completion (Actual)

December 6, 2024

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIP2024070123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is proprietary data as part as the investigation.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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