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No more data collection needed under this protocol
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | Group A will start with the current marketed firmware. |
|
| Group B | Other | Group B will start with the firmware in development. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Power Knee Firmware Update | Device | The firmware in development will be uploaded to the device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 2MWT | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pete Simpson | Össur Americas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oakland Orthopedic Appliances Inc | Bay City | Michigan | 48708 | United States |
This is proprietary data as part as the investigation.
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6 subjects with transfemoral amputation provided informed consent and were formally enrolled in the study, as reflected in the Protocol Section (6). However, one enrolled subject did not proceed to randomization due to low activity level and fatigue, and therefore did not start the intervention. As a result, only 5 participants were assigned to an Arm/Group and included in the Participant Flow module (5), and their data are presented in the Baseline Characteristics and analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Current Marketed Firmware Before New Firmware | Group A will start with the current marketed firmware. Power Knee Firmware Update: The firmware in development will be uploaded to the device. Power Knee Current Marketed Firmware: The current marketed firmware will be uploaded to the device. |
| FG001 | New Firmware Before Current Marketed Firmware | Group B will start with the firmware in development. Power Knee Firmware Update: The firmware in development will be uploaded to the device. Power Knee Current Marketed Firmware: The current marketed firmware will be uploaded to the device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One subject did not complete the protocol and were not randomized in a group due to a low activity level and some fatigue. Hence, their data is not analyzed, only five subjects were included in the data analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Combined Crossover Evaluation Group | For the analysis, data from both participant groups were pooled. Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware. Power Knee Firmware Update: The investigational (new) firmware was installed on the device. Power Knee Current Marketed Firmware: The existing marketed firmware was installed on the device. In Group A, participants first used the current marketed firmware before switching to the investigational firmware. In Group B, participants first used the investigational firmware before switching to the current marketed firmware. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One subject did not complete the protocol and were not randomized in a group due to a low activity level and some fatigue. Hence, their data is not analyzed, only five subjects were included in the data analysis. |
| 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 | 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 | Posted | Count of Participants | Participants | after acclimatization at day 1 during the single study event |
|
5 days
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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 | Current Marketed Firmware Before New Firmware | Group A will start with the current marketed firmware. Power Knee Firmware Update: The firmware in development will be uploaded to the device. Power Knee Current Marketed Firmware: The current marketed firmware will be uploaded to the device. |
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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 | Nov 5, 2024 | Nov 24, 2025 | Prot_SAP_001.pdf |
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| Power Knee Current Marketed Firmware | Device | The current marketed firmware will be uploaded to the device. |
|
| 10mWT | 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 | Stair assessment index (0-13) | after acclimatization at day 1 during the single study event |
| Entering Stair Ascent Mode | 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 | 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 | 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 |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | One subject did not complete the protocol and were not randomized in a group due to a low activity level and some fatigue. Hence, their data is not analyzed, only five subjects were included in the data analysis. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Amputation level Transfemoral | One subject did not complete the protocol and were not randomized in a group due to a low activity level and some fatigue. Hence, their data is not analyzed, only five subjects were included in the data analysis. | Count of Participants | Participants |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | after acclimatization at day 1 during the single study event |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | after acclimatization at day 1 during the single study event |
|
|
|
| Other Pre-specified | 2MWT | 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). | Only 2 subjects performed this test. | Posted | Mean | Standard Deviation | meters | after acclimatization at day 1 during the single study event |
|
|
|
| Other Pre-specified | 10mWT | 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. | Only 4 subjects performed this test. | Posted | Mean | Standard Deviation | seconds | after acclimatization at day 1 during the single study event |
|
|
|
| Other Pre-specified | Stair Ascent Activity | Stair assessment index (0-13) | Data for stair ascent activities (Outcome Measures 6-9) could not be reported because these activities were not tested during the study. The investigational firmware was not finalized in time for stair ascent, and therefore this activity was not included in the testing protocol. As a result, no data were collected for these Outcome Measures. In the protocol, data related to stair ascent was considered exploratory. | Posted | after acclimatization at day 1 during the single study event |
|
|
| Other Pre-specified | Entering Stair Ascent Mode | 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 | Data for stair ascent activities (Outcome Measures 6-9) could not be reported because these activities were not tested during the study. The investigational firmware was not finalized in time for stair ascent, and therefore this activity was not included in the testing protocol. As a result, no data were collected for these Outcome Measures. In the protocol, data related to stair ascent was considered exploratory. | Posted | after acclimatization at day 1 during the single study event |
|
|
| Other Pre-specified | Exiting From Stair Ascent Mode | 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. | Data for stair ascent activities (Outcome Measures 6-9) could not be reported because these activities were not tested during the study. The investigational firmware was not finalized in time for stair ascent, and therefore this activity was not included in the testing protocol. As a result, no data were collected for these Outcome Measures. In the protocol, data related to stair ascent was considered exploratory. | Posted | after acclimatization at day 1 during the single study event |
|
|
| Other Pre-specified | Perception of Stair Ascent Activity | Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing stair ascent activity | Data for stair ascent activities (Outcome Measures 6-9) could not be reported because these activities were not tested during the study. The investigational firmware was not finalized in time for stair ascent, and therefore this activity was not included in the testing protocol. As a result, no data were collected for these Outcome Measures. In the protocol, data related to stair ascent was considered exploratory. | Posted | after acclimatization at day 1 during the single study event |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | New Firmware Before Current Marketed Firmware | Group B will start with the firmware in development. Power Knee Firmware Update: The firmware in development will be uploaded to the device. Power Knee Current Marketed Firmware: The current marketed firmware will be uploaded to the device. | 0 | 3 | 0 | 3 | 0 | 3 |
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| Title | Measurements |
|---|
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| Title | Measurements |
|---|
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