AmputationNCT06748729

Clinical Investigation (Beta) of a New Developed Prosthetic Knee

A study testing Navii Knee in people with Amputation, run by Össur Iceland ehf at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Amputation
What is being tested?: Navii Knee
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 26 Feb 2024to 28 Mar 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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Össur Orlando
Orlando, Florida, 32819

Other trials in United States

About this study

Official title: Investigation on Performance of a New Developed Prosthetic Knee

Read the 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
Being tested: Navii Knee
Keywords: Trans-femoral, Prosthetic knee, Amputees

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Navii KneeDevice
Microprocessor controlled prosthetic knee (MPK)

Study groups in NCT06748729
Study group	Role	What they receive
Exploratory testing of a new prosthetic knee	Experimental	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. Receives: Device: Navii Knee

What is being measured

The primary outcome is the main question the study is designed to answer.

Satisfaction on Ramp Descent With the New Microprocessor-controlled Prosthetic Knee (MPK)
Satisfaction on ramp descent with the new MPK compared to prescribed device In-house questionnaire and Scale used: worse, same, better.
Measured: After 4 weeks of use
Satisfaction on Stair Descent With the New Microprocessor-controlled Prosthetic Knee (MPK)
Satisfaction on stair descent with the new MPK compared to prescribed device In-house questionnaire and Scale used: worse, same, better
Measured: After 4 weeks of use
Satisfaction on Level Ground Walking Activity
Satisfaction on level ground walking activity with the new MPK compared to prescribed device In-house questionnaire and Scale used: worse, same, better
Measured: After 4 weeks of use
Change in Overall Satisfaction From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use
The PEQ (Prosthesis Evaluation Questionnaire) assesses the quality of life and satisfaction for prosthetic users using a visual analog scale from 0 to 100, where higher scores indicate more positive responses. Only certain subsets were used, including the ambulation subscale, satisfaction and safety questions, and utility questions. The hypothesis tested was that the new MPK has a 95% chance of not negatively affecting overall satisfaction. If scores in Visit 2 (with the investigational device) were higher than in Visit 1 (with the prescribed device), it would support the hypothesis. The confidence interval bars represented in graph were visually compared to the margin of non-inferiority. No further statistical analysis was done.
Measured: Baseline and After 4 weeks of use
Change in Distance Walked During 2-Minute Walk Test (2MWT) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use
Average difference in distance walked in 2MWT with the new MPK compared to comparator (prescribed device) User walk for 2 minutes in their self selected walking speed on a 30 meter track.
The hypothesis being tested is that the new MPK has a 95% probability of not negatively affecting the distance walked on 2MWT.
For this hypothesis, if scores in visit 2 (subjects using the investigational device) were higher than in visit 1 (subjects using their prescribed device), the difference of Visit 2 - Visit 1 would be positive and would therefore support the corresponding hypothesis.
The confidence interval bars represented in graph were visually compared to the margin of non-inferiority. No further statistical analysis was done.
Measured: Baseline and After 4 weeks of use
Change in Time for the Timed Up and Go Test (TUG) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use
The TUG test is a simple evaluative test used to measure functional mobility and assess fall risk. Reduction in time (measured in seconds) to complete indicates improvement in mobility. Average time needed to perform the TUG with the new MPK compared to comparator (prescribed device). The hypothesis being tested is that the new MPK has a 95% probability of not negatively affecting the time needed to complete the TUG. For this hypothesis, if the completion times of the TUG during the Visit 2 (subjects using the investigational device) were lower than the ones in Visit 1 (subjects using their prescribed device), the difference of Visit 2 - Visit 1 would be negative and would therefore support the corresponding hypothesis. The confidence interval bars represented in graph were visually compared to the margin of non-inferiority. No further statistical analysis was done.
Measured: Baseline and After 4 weeks of use
Change in T-score for the Prosthetic Limb Users Survey of Mobility (PLUS-M) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use
Ability to ambulate over typical environmental obstacles is measured by the PLUS-M, using the T-score with the new MPK compared to the comparator (prescribed device). The PLUS-M is a self-report tool for assessing mobility in adults with lower limb amputation. The PLUS-M produces a T-score, which is standardized with a mean of 50 and a standard deviation of 10. Higher T-scores indicate greater mobility, with scores ranging from 17.5 to 76.6, based on responses to 44 questions. Only T-scores should be reported, as they are valid and comparable, unlike raw scores. The hypothesis being tested is that the new MPK has a 95% probability of not negatively affecting the PLUS-M score. If Visit 2 scores (using the investigational device) are higher than Visit 1 scores (using the prescribed device), the positive difference supports the hypothesis. The confidence interval bars represented in graph were visually compared to the margin of non-inferiority. No further statistical analysis was done.
Measured: Baseline and After 4 weeks of use
Change in Activities-Specific Balance Confidence Score (ABC) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use
The ABC-scale is a 16-item questionnaire measuring confidence in performing ambulatory activities without falling, scored from 0 (no confidence) to 100 (full confidence). Cut-off scores define physical functioning: below 50% indicates low, 50-80% moderate, and above 80% high functioning. The hypothesis is that the new MPK has a 95% chance of not negatively impacting the ABC score. If Visit 2 scores (using the investigational device) exceed Visit 1 scores (using the prescribed device), it supports the hypothesis. Confidence interval bars in the graph were visually compared to the margin of non-inferiority, with no additional statistical analysis conducted.
Measured: Baseline and After 4 weeks of use

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Feb 202428 Mar 2024

First posted27 Dec 2024
Study start26 Feb 2024
Primary completion28 Mar 2024
Study completion28 Mar 2024

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: Not applicable
Intervention model: Single group
Model description: The test will be a non-randomized single group repeated measures open label prospective design with observational and self-report measures.
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06748729
Sponsor's protocol ID: CIP2023120529
Status last verified: Sep 2025
First submitted: 17 Apr 2024
Last updated: 4 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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CNS Changes Following Upper Limb Loss
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All Amputation trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation on Performance of a New Developed Prosthetic Knee
ClinicalTrials.gov ID: NCT06748729
Acronym / sponsor ID: CIP2023120529
Conditions: Amputation
Keywords: Trans-femoral, Prosthetic knee, Amputees
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Össur Iceland ehfIndustry (pharma, biotech, devices)
Study start: 26 Feb 2024 (actual)
Primary completion: 28 Mar 2024 (actual)
Study completion: 28 Mar 2024 (actual)
First posted: 27 Dec 2024 (actual)
Results: Posted 4 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The test will be a non-randomized single group repeated measures open label prospective design with observational and self-report measures.

Arm	Type	Receives
Exploratory testing of a new prosthetic knee	Experimental	Device: Navii KneeThe 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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.

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
Navii KneeMicroprocessor controlled prosthetic knee (MPK)	Device	Exploratory testing of a new prosthetic knee

Primary outcome

Satisfaction on Ramp Descent With the New Microprocessor-controlled Prosthetic Knee (MPK)
Time frame: After 4 weeks of use
Satisfaction on ramp descent with the new MPK compared to prescribed device In-house questionnaire and Scale used: worse, same, better.
Satisfaction on Stair Descent With the New Microprocessor-controlled Prosthetic Knee (MPK)
Time frame: After 4 weeks of use
Satisfaction on stair descent with the new MPK compared to prescribed device In-house questionnaire and Scale used: worse, same, better
Satisfaction on Level Ground Walking Activity
Time frame: After 4 weeks of use
Satisfaction on level ground walking activity with the new MPK compared to prescribed device In-house questionnaire and Scale used: worse, same, better
Change in Overall Satisfaction From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use
Time frame: Baseline and After 4 weeks of use
The PEQ (Prosthesis Evaluation Questionnaire) assesses the quality of life and satisfaction for prosthetic users using a visual analog scale from 0 to 100, where higher scores indicate more positive responses. Only certain subsets were used, including the ambulation subscale, satisfaction and safety questions, and utility questions. The hypothesis tested was that the new MPK has a 95% chance of not negatively affecting overall satisfaction. If scores in Visit 2 (with the investigational device) were higher than in Visit 1 (with the prescribed device), it would support the hypothesis. The confidence interval bars represented in graph were visually compared to the margin of non-inferiority. No further statistical analysis was done.
Change in Distance Walked During 2-Minute Walk Test (2MWT) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use
Time frame: Baseline and After 4 weeks of use
Average difference in distance walked in 2MWT with the new MPK compared to comparator (prescribed device) User walk for 2 minutes in their self selected walking speed on a 30 meter track. The hypothesis being tested is that the new MPK has a 95% probability of not negatively affecting the distance walked on 2MWT. For this hypothesis, if scores in visit 2 (subjects using the investigational device) were higher than in visit 1 (subjects using their prescribed device), the difference of Visit 2 - Visit 1 would be positive and would therefore support the corresponding hypothesis. The confidence interval bars represented in graph were visually compared to the margin of non-inferiority. No further statistical analysis was done.
Change in Time for the Timed Up and Go Test (TUG) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use
Time frame: Baseline and After 4 weeks of use
The TUG test is a simple evaluative test used to measure functional mobility and assess fall risk. Reduction in time (measured in seconds) to complete indicates improvement in mobility. Average time needed to perform the TUG with the new MPK compared to comparator (prescribed device). The hypothesis being tested is that the new MPK has a 95% probability of not negatively affecting the time needed to complete the TUG. For this hypothesis, if the completion times of the TUG during the Visit 2 (subjects using the investigational device) were lower than the ones in Visit 1 (subjects using their prescribed device), the difference of Visit 2 - Visit 1 would be negative and would therefore support the corresponding hypothesis. The confidence interval bars represented in graph were visually compared to the margin of non-inferiority. No further statistical analysis was done.
Change in T-score for the Prosthetic Limb Users Survey of Mobility (PLUS-M) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use
Time frame: Baseline and After 4 weeks of use
Ability to ambulate over typical environmental obstacles is measured by the PLUS-M, using the T-score with the new MPK compared to the comparator (prescribed device). The PLUS-M is a self-report tool for assessing mobility in adults with lower limb amputation. The PLUS-M produces a T-score, which is standardized with a mean of 50 and a standard deviation of 10. Higher T-scores indicate greater mobility, with scores ranging from 17.5 to 76.6, based on responses to 44 questions. Only T-scores should be reported, as they are valid and comparable, unlike raw scores. The hypothesis being tested is that the new MPK has a 95% probability of not negatively affecting the PLUS-M score. If Visit 2 scores (using the investigational device) are higher than Visit 1 scores (using the prescribed device), the positive difference supports the hypothesis. The confidence interval bars represented in graph were visually compared to the margin of non-inferiority. No further statistical analysis was done.
Change in Activities-Specific Balance Confidence Score (ABC) From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use
Time frame: Baseline and After 4 weeks of use
The ABC-scale is a 16-item questionnaire measuring confidence in performing ambulatory activities without falling, scored from 0 (no confidence) to 100 (full confidence). Cut-off scores define physical functioning: below 50% indicates low, 50-80% moderate, and above 80% high functioning. The hypothesis is that the new MPK has a 95% chance of not negatively impacting the ABC score. If Visit 2 scores (using the investigational device) exceed Visit 1 scores (using the prescribed device), it supports the hypothesis. Confidence interval bars in the graph were visually compared to the margin of non-inferiority, with no additional statistical analysis conducted.

Results and safety

Results posted to the registry on 4 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exploratory Testing of a New Prosthetic Knee	11	10

Primary outcome: Satisfaction on Ramp Descent With the New Microprocessor-controlled Prosthetic Knee (MPK)

Time frame: After 4 weeks of use. Count of participants. Unit: Participants

Measure	Exploratory Testing of a New Prosthetic Knee n = 10
Rheo Knee Users: worse	1
Rheo Knee Users: same	0
Rheo Knee Users: better	3
Hydraulic Users: worse	4
Hydraulic Users: same	1
Hydraulic Users: better	1

Population analysed: 4 subjects had magnetorheological working MPK, 6 subjects had a hydraulic one.

Primary outcome: Satisfaction on Stair Descent With the New Microprocessor-controlled Prosthetic Knee (MPK)

Time frame: After 4 weeks of use. Count of participants. Unit: Participants

Measure	Exploratory Testing of a New Prosthetic Knee n = 10
In-house questionnaire Rheo Knee Users: worse	0
In-house questionnaire Rheo Knee Users: same	1
In-house questionnaire Rheo Knee Users: better	3
In-house questionnaire Hydraulic Users: worse	5
In-house questionnaire Hydraulic Users: same	0
In-house questionnaire Hydraulic Users: better	1

Population analysed: 4 subjects had magnetorheological working MPK, 6 subjects had a hydraulic one.

Primary outcome: Satisfaction on Level Ground Walking Activity

Time frame: After 4 weeks of use. Count of participants. Unit: Participants

Measure	Exploratory Testing of a New Prosthetic Knee n = 10
Rheo Knee users: Worse	0
Rheo Knee users: Same	4
Rheo Knee users: Better	0
Hydraulic users: Worse	0
Hydraulic users: Same	6
Hydraulic users: Better	0

Population analysed: 4 subjects had magnetorheological working MPK, 6 subjects had a hydraulic one.

Primary outcome: Change in Overall Satisfaction From Baseline With Prescribed Device to After 4 Weeks of Investigational Device Use

Time frame: Baseline and After 4 weeks of use. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Exploratory Testing of a New Prosthetic Knee n = 10
Rheo Knee users	2.6 (-6.2 to 11.5)
Hydraulic users	7.4 (-9.1 to 23.8)
All users	5.5 (-3.4 to 14.3)

Population analysed: 4 subjects had magnetorheological working MPK, 6 subjects had a hydraulic one.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exploratory Testing of a New Prosthetic Knee	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Amputation

RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
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Recruiting
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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.

Kurt N. Gruben 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 Navii Knee in people with 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 4 Sep 2025. 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 4 Sep 2025). 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?

Satisfaction on Ramp Descent With the New Microprocessor-controlled Prosthetic Knee (MPK) (time frame: After 4 weeks of use). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06748729.

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 4 Sep 2025.