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

NCT06620861 | Terminated Results FDA Device

• 1 other identifier: CIP2024070123
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amputation; Transfemoral Amputation

Keywords

Microprocessor knee; prosthesis; powered prosthesis

Outcome Measures

Primary Outcomes (3)

• Sit to Stand Activity

  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

  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

  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 Outcomes (6)

• 2MWT

  after acclimatization at day 1 during the single study event

• 10mWT

  after acclimatization at day 1 during the single study event

• Stair Ascent Activity

  after acclimatization at day 1 during the single study event

Study Arms (2)

Group A

OTHER

Group A will start with the current marketed firmware.

Device: Power Knee Firmware Update; Device: Power Knee Current Marketed Firmware

Group B

OTHER

Group B will start with the firmware in development.

Device: Power Knee Firmware Update; Device: Power Knee Current Marketed Firmware

Interventions

Power Knee Firmware Update DEVICE

The firmware in development will be uploaded to the device.

Group A; Group B

Power Knee Current Marketed Firmware DEVICE

The current marketed firmware will be uploaded to the device.

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Össur Iceland ehf: lead

Study Sites (1)

Oakland Orthopedic Appliances Inc

Bay City, Michigan, 48708, United States

Location

Results Point of Contact

• Title: Laurine Roussillon
• Organization: Össur Iceland ehf.

lroussillon@ossur.com

+3548221812

Study Officials

• Pete Simpson

  Össur Americas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 1, 2024
• Study Start: December 2, 2024
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: January 30, 2026
• Results First Posted: January 30, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)