AmputationNCT06620861
Investigation on a New Power Knee Firmware Update on Gait and Daily Life Activities for Transfemoral Amputees
A study testing Power Knee Firmware Update and Power Knee Current Marketed Firmware in people with Amputation and Transfemoral Amputation, run by Össur Iceland ehf at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Transfemoral Amputation
- What is being tested?
- Power Knee Firmware Update and Power Knee Current Marketed Firmware
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to 6 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oakland Orthopedic Appliances Inc
Bay City, Michigan, 48708
About this study
Official title: 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.
- Conditions
- Amputation, Transfemoral Amputation
- Being tested
- Power Knee Firmware Update, Power Knee Current Marketed Firmware
- Keywords
- Microprocessor knee, prosthesis, powered prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power Knee Firmware UpdateDevice
The firmware in development will be uploaded to the device.
Power Knee Current Marketed FirmwareDevice
The current marketed firmware will be uploaded to the device.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Group A will start with the current marketed firmware. Receives: Device: Power Knee Firmware Update; Device: Power Knee Current Marketed Firmware |
| Group B | Other | Group B will start with the firmware in development. Receives: Device: Power Knee Firmware Update; Device: Power Knee Current Marketed Firmware |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: after acclimatization at day 1 during the single study event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start2 Dec 2024
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Why it stopped: No more data collection needed under this protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pete Simpson, Principal investigator, Össur Americas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620861
- Sponsor's protocol ID
- CIP2024070123
- Status last verified
- Oct 2025
- First submitted
- 24 Sep 2024
- Last updated
- 30 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is proprietary data as part as the investigation.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on a New Power Knee Firmware Update on Gait and Daily Life Activities, a Randomized Controlled Double-blinded Cross-over Investigation
- ClinicalTrials.gov ID
- NCT06620861
- Acronym / sponsor ID
- CIP2024070123
- Conditions
- Amputation, Transfemoral Amputation
- Keywords
- Microprocessor knee, prosthesis, powered prosthesis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No more data collection needed under this protocol
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Posted 30 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Device: Power Knee Firmware Update, Device: Power Knee Current Marketed FirmwareGroup A will start with the current marketed firmware. |
| Group B | Other | Device: Power Knee Firmware Update, Device: Power Knee Current Marketed FirmwareGroup B will start with the firmware in development. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power Knee Firmware UpdateThe firmware in development will be uploaded to the device. | Device | Group A, Group B |
| Power Knee Current Marketed FirmwareThe current marketed firmware will be uploaded to the device. | Device | Group A, Group B |
Primary outcome
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
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. This is proprietary data as part as the investigation.
Related trials for Amputation
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
Recruiting
Hand Prosthesis Usability and Performance
Amputation
Recruiting
E-Socket, Diagnostic Monitoring
Trans-Tibial Amputation
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pete Simpson principal investigator
Össur Americas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power Knee Firmware Update and Power Knee Current Marketed Firmware in people with Amputation and Transfemoral Amputation, run by Össur Iceland ehf at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sit to Stand Activity (time frame: after acclimatization at day 1 during the single study event). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.