Lower Limb Amputation Above Knee (Injury)
Conditions
Brief summary
The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on level walking and secondarily in safety, stair and hill mobility, activities of daily living, satisfaction and preference.
Detailed description
During the last two decades many microprocessor controlled knee joints (MPK) appeared on the market.The newly developed C-Leg 4 aims to provide improved standing function while in the same time offering technology of knee´s previous version (C-Leg 3). Since added functional benefit of a knee joint cannot be anticipated just due to the fact that the knee is controlled by the microprocessor, the aim of this post-market study is to evaluate the safety, functional mobility and satisfaction of the microprocessor controlled prosthetic knee components C-Leg 3 and C-Leg 4 in comparison to mechanical knee joints. Additional goal is to improve the methodological quality of research conducted in the field.
Interventions
DEVICEC-Leg 4
Microprocessor Controlled Knee
DEVICEC-Leg 3
Microprocessor Controlled Knee
Sponsors
Otto Bock Healthcare Products GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Person is \>18 years old. * Person is a unilateral transfemoral or knee-disarticulation amputee with stabilized residual limb. * Person is a K2, K3 or K4 ambulator based on Medicare Functional Classification Level (MFCL). * Person is currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee for at least 6 months. * Person was never fitted with microprocessor controlled prosthetic knee joint. * Person is willing and able to independently provide informed consent. * Person is willing to comply with study procedures. * Person wears prosthesis daily and ≥ 8 hours/day. * Person is walking on average 1km/day. * Person is walking not slower than 3km/h (\ 0.8m/s) (based on 10m walk test conducted during recruiting). * Person is walking on level ground in a step over step manner.
Exclusion criteria
* Person is under 18 years of age. * Person who weighs more than 136kg. * Person who weighs less than 50kg. * Person who is pregnant. * Person has a history of chronic skin breakdown on the residual limb. * Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking). * Person falls ≥ once a week due to the reasons that could not be corrected by the new prosthesis (for ex. problems with vestibular system). * Person is using under arm axillary crutches or walker. * Person in an emergency, life threatening situation. * Person is unwilling/unable to follow instructions. * Person who is not available to follow the entire study protocol. * Person who is participating in another study or intends to participate in another study during this study duration. * Person who cannot personally provide their consent. * Person who is not wearing prosthesis 8hours/day on average. * Person who has a score on 10m walk test less than 3km/h (\ 0.8m/s) (based on 10m walk test conducted during recruiting). * Person who walks on average less than 1km per day. * Person who is not able to walk on level ground in a step over step manner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 Minute Gait Test | Baseline and after acclimation period (30-90 days after fitting) | A measure of walking endurance, the distance walked in meters after 6 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stairs Assessment Index (SAI) | Baseline and after acclimation period (30-90 days after fitting) | Participants are scored on a 14-level scale for independence, technique and step length for ascending and descending a 12-step ADA-compliant stairwell. The maximum score is 13 and the minimum 0. Higher scores indicate greater independence. Time to descend stairs was also recorded. |
| Change in Hill Assessment Index (HAI) | Baseline and after acclimation period (30-90 days after fitting) | Participants are scored on a 12-level scale for independence, technique and step length for descending a 5m, 5-degree downgrade hill at self selected speed. The maximum score is 11 and the minimum 0. Higher scores indicate greater independence. Time to descend the hill was also recorded. |
| Change in Four Step Square Test (FSST) | Baseline and after acclimation period (30-90 days after fitting) | Time to complete a stepping sequence through 4 squares as quickly as possible. The test involves stepping forward, backward and sideways to the left and right while face the same direction. |
| Change in Activities-specific Balance Confidence (ABC) Scale | Baseline and after acclimation period (30-90 days after fitting) | Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores. |
| Change in 10 Meter Gait Test | Baseline and after acclimation period (30-90 days after fitting) | Average gait speed over middle 6 meters of a 10-meter course at both self-selected and fastest safe walking speeds |
| Change in Amputee Body Image Scale (ABIS) | Baseline and after acclimation period (30-90 days after fitting) | The ABIS assesses how an amputee perceives and feels about his or her body experience. The scale addresses several different domains, including: 1) body appearance; 2) body function; 3effective distress; and 4) behavioral avoidance in social situations. The scale produces scores that range from 1 to 100, with low scores indicating the relative absence of a body image concern and higher scores indicating the presence of a more serious body-image concern. |
| Change in Number of Stumbles and Falls | Baseline and after acclimation period (30-90 days after fitting) | Stumbles and falls in the previous 30 days for each studied device based on records in a subject log book. At baseline, users were asked to recall the number of stumbles and falls in the previous 30 days. |
| Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee) | At 3rd study visit after having been fitted and acclimatized to each of the study devices | The user´s knee preference is assessed with the question: Which prosthesis do you prefer? |
| Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) | Baseline and after acclimation period (30-90 days after fitting) | The PLUS-M 12-item short form is a valid and reliable self-reported measure for the mobility of adults with lower limb amputations. PLUS-M asks about the patient's ability to perform simple and complex tasks. Higher PLUS-M scores correspond with greater mobility. T-scores range from 21.8 to 71.4. A T-score has a mean of 50 and a standard deviation (SD) of 10. A PLUS-M T-score of 50 represents the mean mobility reported by the development sample (i.e., people with unilateral amputation). |
Countries
Austria, Belgium
Participant flow
Pre-assignment details
5 subjects were excluded from the study prior to randomization: 3 subjects had adverse events, 1 subject could not be fitted with the intervention device due to anthropomorphic characteristics, and 1 subject withdrew due to a change in work situation.
Participants by arm
| Arm | Count |
|---|---|
| C-Leg 3, Then C-Leg 4 C-Leg 4: Microprocessor Controlled Knee
C-Leg 3: Microprocessor Controlled Knee | 5 |
| C-Leg 4, Then C-Leg 3 C-Leg 4: Microprocessor Controlled Knee
C-Leg 3: Microprocessor Controlled Knee | 8 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (90 Days) | Adverse Event | 1 | 1 |
| Second Intervention (30 Days) | Protocol Violation | 2 | 2 |
Baseline characteristics
| Characteristic | C-Leg 3, Then C-Leg 4 | C-Leg 4, Then C-Leg 3 | Total |
|---|---|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 4.95 | 58.5 years STANDARD_DEVIATION 12.2 | 60.6 years STANDARD_DEVIATION 10.2 |
| Amputation cause cancer | 1 Participants | 5 Participants | 6 Participants |
| Amputation cause infection | 1 Participants | 1 Participants | 2 Participants |
| Amputation cause trauma | 1 Participants | 1 Participants | 2 Participants |
| Amputation cause vascular disease | 2 Participants | 1 Participants | 3 Participants |
| Amputation side left | 1 Participants | 3 Participants | 4 Participants |
| Amputation side right | 4 Participants | 5 Participants | 9 Participants |
| Amputation type Knee disarticulation | 5 Participants | 4 Participants | 9 Participants |
| Amputation type Transfemoral | 0 Participants | 4 Participants | 4 Participants |
| Current knee prosthesis (NMPK) 3R106 | 1 Participants | 3 Participants | 4 Participants |
| Current knee prosthesis (NMPK) 3R15 | 0 Participants | 1 Participants | 1 Participants |
| Current knee prosthesis (NMPK) 3R60 | 2 Participants | 1 Participants | 3 Participants |
| Current knee prosthesis (NMPK) 3R80 | 2 Participants | 1 Participants | 3 Participants |
| Current knee prosthesis (NMPK) Multiaxial | 0 Participants | 1 Participants | 1 Participants |
| Current knee prosthesis (NMPK) Polycentric | 0 Participants | 1 Participants | 1 Participants |
| Distance covered per day | 3.6 km STANDARD_DEVIATION 2.1 | 3.25 km STANDARD_DEVIATION 1.5 | 3.38 km STANDARD_DEVIATION 1.7 |
| Height | 177.4 cm STANDARD_DEVIATION 7.54 | 172.13 cm STANDARD_DEVIATION 9.4 | 174.15 cm STANDARD_DEVIATION 8.81 |
| Hours of wearing prosthesis per day | 12.4 hours STANDARD_DEVIATION 2.6 | 12.4 hours STANDARD_DEVIATION 2.7 | 12.4 hours STANDARD_DEVIATION 2.6 |
| Medicare Functional Classification Level (MFCL) 2 | 1 Participants | 1 Participants | 2 Participants |
| Medicare Functional Classification Level (MFCL) 3 | 4 Participants | 6 Participants | 10 Participants |
| Medicare Functional Classification Level (MFCL) 4 | 0 Participants | 1 Participants | 1 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Austria | 2 participants | 2 participants | 5 participants |
| Region of Enrollment Belgium | 3 participants | 6 participants | 8 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
| Time since amputation | 21.8 years STANDARD_DEVIATION 23.6 | 23.0 years STANDARD_DEVIATION 14.9 | 22.54 years STANDARD_DEVIATION 17.74 |
| Weight | 74.4 kg STANDARD_DEVIATION 12.4 | 73.9 kg STANDARD_DEVIATION 14.4 | 74.1 kg STANDARD_DEVIATION 13.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 3 / 13 | 3 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
Change in 6 Minute Gait Test
A measure of walking endurance, the distance walked in meters after 6 minutes.
Time frame: Baseline and after acclimation period (30-90 days after fitting)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C-Leg 3 | Change in 6 Minute Gait Test | Baseline | 380.4 meters | Standard Deviation 69.66 |
| C-Leg 3 | Change in 6 Minute Gait Test | Change from Baseline after accommodation | 35.9 meters | Standard Deviation 20.26 |
| C-Leg 4 | Change in 6 Minute Gait Test | Baseline | 380.4 meters | Standard Deviation 69.66 |
| C-Leg 4 | Change in 6 Minute Gait Test | Change from Baseline after accommodation | 26.7 meters | Standard Deviation 33.87 |
Comparison: C-Leg 3 vs. NMPK (Baseline)p-value: 0.01t-test, 1 sided
Comparison: C-Leg 4 vs. NMPK (Baseline)p-value: 0.04t-test, 1 sided
Secondary
Change in 10 Meter Gait Test
Average gait speed over middle 6 meters of a 10-meter course at both self-selected and fastest safe walking speeds
Time frame: Baseline and after acclimation period (30-90 days after fitting)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C-Leg 3 | Change in 10 Meter Gait Test | SSWS at Baseline | 1.11 meters per second | Standard Deviation 0.168 |
| C-Leg 3 | Change in 10 Meter Gait Test | SSWS after acclimation | 0.00 meters per second | Standard Deviation 0.06 |
| C-Leg 3 | Change in 10 Meter Gait Test | FWS at Baseline | 1.36 meters per second | Standard Deviation 0.262 |
| C-Leg 3 | Change in 10 Meter Gait Test | FWS after acclimation | 0.21 meters per second | Standard Deviation 0.15 |
| C-Leg 4 | Change in 10 Meter Gait Test | FWS after acclimation | -0.03 meters per second | Standard Deviation 0.08 |
| C-Leg 4 | Change in 10 Meter Gait Test | SSWS at Baseline | 1.11 meters per second | Standard Deviation 0.168 |
| C-Leg 4 | Change in 10 Meter Gait Test | FWS at Baseline | 1.36 meters per second | Standard Deviation 0.262 |
| C-Leg 4 | Change in 10 Meter Gait Test | SSWS after acclimation | -0.25 meters per second | Standard Deviation 0.14 |
Secondary
Change in Activities-specific Balance Confidence (ABC) Scale
Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores.
Time frame: Baseline and after acclimation period (30-90 days after fitting)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C-Leg 3 | Change in Activities-specific Balance Confidence (ABC) Scale | Baseline ABC | 72.4 score on a scale | Standard Deviation 9.73 |
| C-Leg 3 | Change in Activities-specific Balance Confidence (ABC) Scale | Change in ABC after fitting and acclimation | 1.4 score on a scale | Standard Deviation 7.83 |
| C-Leg 4 | Change in Activities-specific Balance Confidence (ABC) Scale | Baseline ABC | 72.4 score on a scale | Standard Deviation 9.73 |
| C-Leg 4 | Change in Activities-specific Balance Confidence (ABC) Scale | Change in ABC after fitting and acclimation | 2.7 score on a scale | Standard Deviation 8.75 |
Secondary
Change in Amputee Body Image Scale (ABIS)
The ABIS assesses how an amputee perceives and feels about his or her body experience. The scale addresses several different domains, including: 1) body appearance; 2) body function; 3effective distress; and 4) behavioral avoidance in social situations. The scale produces scores that range from 1 to 100, with low scores indicating the relative absence of a body image concern and higher scores indicating the presence of a more serious body-image concern.
Time frame: Baseline and after acclimation period (30-90 days after fitting)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C-Leg 3 | Change in Amputee Body Image Scale (ABIS) | Baseline ABIS | 55.1 score on a scale | Standard Deviation 13.01 |
| C-Leg 3 | Change in Amputee Body Image Scale (ABIS) | Change in ABIS after fitting and acclimation | 1.9 score on a scale | Standard Deviation 7.34 |
| C-Leg 4 | Change in Amputee Body Image Scale (ABIS) | Baseline ABIS | 55.1 score on a scale | Standard Deviation 13.01 |
| C-Leg 4 | Change in Amputee Body Image Scale (ABIS) | Change in ABIS after fitting and acclimation | -0.4 score on a scale | Standard Deviation 6.97 |
Secondary
Change in Four Step Square Test (FSST)
Time to complete a stepping sequence through 4 squares as quickly as possible. The test involves stepping forward, backward and sideways to the left and right while face the same direction.
Time frame: Baseline and after acclimation period (30-90 days after fitting)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C-Leg 3 | Change in Four Step Square Test (FSST) | Baseline FSST | 13.5 seconds | Standard Deviation 3.92 |
| C-Leg 3 | Change in Four Step Square Test (FSST) | FSST after fitting and acclimation | -2.6 seconds | Standard Deviation 1.18 |
| C-Leg 4 | Change in Four Step Square Test (FSST) | Baseline FSST | 13.5 seconds | Standard Deviation 3.92 |
| C-Leg 4 | Change in Four Step Square Test (FSST) | FSST after fitting and acclimation | -2.4 seconds | Standard Deviation 1.77 |
Secondary
Change in Hill Assessment Index (HAI)
Participants are scored on a 12-level scale for independence, technique and step length for descending a 5m, 5-degree downgrade hill at self selected speed. The maximum score is 11 and the minimum 0. Higher scores indicate greater independence. Time to descend the hill was also recorded.
Time frame: Baseline and after acclimation period (30-90 days after fitting)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C-Leg 3 | Change in Hill Assessment Index (HAI) | Baseline HAI (Ascent) | 8.4 score on a scale | Standard Deviation 2.5 |
| C-Leg 3 | Change in Hill Assessment Index (HAI) | Change in HAI (Ascent) after fitting and acclimation | 1.9 score on a scale | Standard Deviation 2 |
| C-Leg 3 | Change in Hill Assessment Index (HAI) | Baseline HAI (Descent) | 7.9 score on a scale | Standard Deviation 2.8 |
| C-Leg 3 | Change in Hill Assessment Index (HAI) | Change in HAI (Descent) after fitting and acclimation | 1.9 score on a scale | Standard Deviation 2 |
| C-Leg 3 | Change in Hill Assessment Index (HAI) | Baseline Descent Time | 6.6 score on a scale | Standard Deviation 2.5 |
| C-Leg 3 | Change in Hill Assessment Index (HAI) | Change in Descent Time after fitting and acclimation | -0.9 score on a scale | Standard Deviation 1.3 |
| C-Leg 4 | Change in Hill Assessment Index (HAI) | Baseline Descent Time | 6.6 score on a scale | Standard Deviation 2.5 |
| C-Leg 4 | Change in Hill Assessment Index (HAI) | Baseline HAI (Ascent) | 8.4 score on a scale | Standard Deviation 2.5 |
| C-Leg 4 | Change in Hill Assessment Index (HAI) | Change in HAI (Descent) after fitting and acclimation | 0.9 score on a scale | Standard Deviation 2.7 |
| C-Leg 4 | Change in Hill Assessment Index (HAI) | Change in HAI (Ascent) after fitting and acclimation | 1.1 score on a scale | Standard Deviation 1.3 |
| C-Leg 4 | Change in Hill Assessment Index (HAI) | Change in Descent Time after fitting and acclimation | -0.4 score on a scale | Standard Deviation 1.4 |
| C-Leg 4 | Change in Hill Assessment Index (HAI) | Baseline HAI (Descent) | 7.9 score on a scale | Standard Deviation 2.8 |
Secondary
Change in Number of Stumbles and Falls
Stumbles and falls in the previous 30 days for each studied device based on records in a subject log book. At baseline, users were asked to recall the number of stumbles and falls in the previous 30 days.
Time frame: Baseline and after acclimation period (30-90 days after fitting)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C-Leg 3 | Change in Number of Stumbles and Falls | Baseline number of stumbles | 3.3 number of stumbles or falls | Standard Deviation 4.07 |
| C-Leg 3 | Change in Number of Stumbles and Falls | Change in number of stumbles after fitting and acclimation | -0.3 number of stumbles or falls | Standard Deviation 2.56 |
| C-Leg 3 | Change in Number of Stumbles and Falls | Baseline number of falls | 1.0 number of stumbles or falls | Standard Deviation 1.53 |
| C-Leg 3 | Change in Number of Stumbles and Falls | Change in number of falls after fitting and acclimation | -0.6 number of stumbles or falls | Standard Deviation 1.62 |
| C-Leg 4 | Change in Number of Stumbles and Falls | Change in number of falls after fitting and acclimation | -0.1 number of stumbles or falls | Standard Deviation 1.77 |
| C-Leg 4 | Change in Number of Stumbles and Falls | Baseline number of stumbles | 3.3 number of stumbles or falls | Standard Deviation 4.07 |
| C-Leg 4 | Change in Number of Stumbles and Falls | Baseline number of falls | 1.0 number of stumbles or falls | Standard Deviation 1.53 |
| C-Leg 4 | Change in Number of Stumbles and Falls | Change in number of stumbles after fitting and acclimation | -0.3 number of stumbles or falls | Standard Deviation 2.29 |
Secondary
Change in Prosthetic Limb Users Survey of Mobility (PLUS-M)
The PLUS-M 12-item short form is a valid and reliable self-reported measure for the mobility of adults with lower limb amputations. PLUS-M asks about the patient's ability to perform simple and complex tasks. Higher PLUS-M scores correspond with greater mobility. T-scores range from 21.8 to 71.4. A T-score has a mean of 50 and a standard deviation (SD) of 10. A PLUS-M T-score of 50 represents the mean mobility reported by the development sample (i.e., people with unilateral amputation).
Time frame: Baseline and after acclimation period (30-90 days after fitting)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C-Leg 3 | Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) | Baseline PLUS-M T-Score | 50.0 T-score | Standard Deviation 6.64 |
| C-Leg 3 | Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) | Change in PLUS T-Score after fitting and acclimation | 0.6 T-score | Standard Deviation 3.3 |
| C-Leg 4 | Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) | Baseline PLUS-M T-Score | 50 T-score | Standard Deviation 6.64 |
| C-Leg 4 | Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) | Change in PLUS T-Score after fitting and acclimation | 0.8 T-score | Standard Deviation 3.27 |
Secondary
Change in Stairs Assessment Index (SAI)
Participants are scored on a 14-level scale for independence, technique and step length for ascending and descending a 12-step ADA-compliant stairwell. The maximum score is 13 and the minimum 0. Higher scores indicate greater independence. Time to descend stairs was also recorded.
Time frame: Baseline and after acclimation period (30-90 days after fitting)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| C-Leg 3 | Change in Stairs Assessment Index (SAI) | Baseline SAI (Ascent) | 5 score on a scale | Standard Deviation 2.6 |
| C-Leg 3 | Change in Stairs Assessment Index (SAI) | Change in SAI (Ascent) after fitting and acclimation | -0.6 score on a scale | Standard Deviation 1.5 |
| C-Leg 3 | Change in Stairs Assessment Index (SAI) | Baseline SAI (Descent) | 4 score on a scale | Standard Deviation 1.6 |
| C-Leg 3 | Change in Stairs Assessment Index (SAI) | Change in SAI (Descent) after fitting and acclimation | 5.9 score on a scale | Standard Deviation 3.2 |
| C-Leg 3 | Change in Stairs Assessment Index (SAI) | Baseline time to descent stairs | 12.7 score on a scale | Standard Deviation 3.95 |
| C-Leg 3 | Change in Stairs Assessment Index (SAI) | Change in time to descent stairs after fitting and acclimation | -2.1 score on a scale | Standard Deviation 1.7 |
| C-Leg 4 | Change in Stairs Assessment Index (SAI) | Baseline time to descent stairs | 12.7 score on a scale | Standard Deviation 3.95 |
| C-Leg 4 | Change in Stairs Assessment Index (SAI) | Baseline SAI (Ascent) | 5 score on a scale | Standard Deviation 2.6 |
| C-Leg 4 | Change in Stairs Assessment Index (SAI) | Change in SAI (Descent) after fitting and acclimation | 5.7 score on a scale | Standard Deviation 2.9 |
| C-Leg 4 | Change in Stairs Assessment Index (SAI) | Change in SAI (Ascent) after fitting and acclimation | 0.0 score on a scale | Standard Deviation 0 |
| C-Leg 4 | Change in Stairs Assessment Index (SAI) | Change in time to descent stairs after fitting and acclimation | -3.1 score on a scale | Standard Deviation 2 |
| C-Leg 4 | Change in Stairs Assessment Index (SAI) | Baseline SAI (Descent) | 4 score on a scale | Standard Deviation 1.6 |
Secondary
Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee)
The user´s knee preference is assessed with the question: Which prosthesis do you prefer?
Time frame: At 3rd study visit after having been fitted and acclimatized to each of the study devices
Population: All subjects with preference data that completed the study were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| C-Leg 3 | Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee) | Number preferring the NMPK | 1 Participants |
| C-Leg 3 | Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee) | Number preferring the C-Leg 4 | 7 Participants |
| C-Leg 3 | Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee) | Number preferring the C-Leg 3 | 3 Participants |