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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navii Knee | Device | Microprocessor controlled prosthetic knee (MPK) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kurt N. Gruben | Össur Americas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Össur Orlando | Orlando | Florida | 32819 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exploratory Testing of a New Prosthetic Knee | Navii Knee: Microprocessor controlled prosthetic knee (MPK) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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11 subjects were enrolled, but only 10 completed the protocol and were included in the data analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Exploratory Testing of a New Prosthetic Knee | Navii Knee: Microprocessor controlled prosthetic knee (MPK) |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 4 subjects had magnetorheological working MPK, 6 subjects had a hydraulic one. | Posted | Count of Participants | Participants | After 4 weeks of use |
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4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exploratory Testing of a New Prosthetic Knee | Navii Knee: Microprocessor controlled prosthetic knee (MPK) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated issue on the residual limb | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laurine Roussillon | Össur Iceland ehf. | +3548221812 | lroussillon@ossur.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2023 | Mar 7, 2025 | Prot_SAP_000.pdf |
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The test will be a non-randomized single group repeated measures open label prospective design with observational and self-report measures.
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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.
| 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. | 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. | 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. | Baseline and After 4 weeks of use |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Amputation level Transfemoral | Count of Participants | Participants |
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| Primary | 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 | 4 subjects had magnetorheological working MPK, 6 subjects had a hydraulic one. | Posted | Count of Participants | Participants | After 4 weeks of use |
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| Primary | 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 | 4 subjects had magnetorheological working MPK, 6 subjects had a hydraulic one. | Posted | Count of Participants | Participants | After 4 weeks of use |
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| Primary | 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. | 4 subjects had magnetorheological working MPK, 6 subjects had a hydraulic one. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and After 4 weeks of use |
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| Primary | 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. | 4 subjects had magnetorheological working MPK, 6 subjects had a hydraulic one. | Posted | Mean | 95% Confidence Interval | meters | Baseline and After 4 weeks of use |
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| Primary | 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. | 4 subjects had magnetorheological working MPK, 6 subjects had a hydraulic one. | Posted | Mean | 95% Confidence Interval | time in seconds | Baseline and After 4 weeks of use |
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| Primary | 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. | 4 subjects had magnetorheological working MPK, 6 subjects had a hydraulic one. | Posted | Mean | 95% Confidence Interval | T-score | Baseline and After 4 weeks of use |
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| Primary | 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. | 4 subjects had magnetorheological working MPK, 6 subjects had a hydraulic one. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and After 4 weeks of use |
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| 0 |
| 11 |
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| 11 |
| 2 |
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| better |
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| In-house questionnaire Hydraulic Users |
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| Better |
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| Hydraulic users |
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| All users |
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| All users |
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| All users |
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| All users |
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| All users |
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