Trial Outcomes & Findings for C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees (NCT NCT02765035)
NCT ID: NCT02765035
Last Updated: 2021-10-14
Results Overview
A measure of walking endurance, the distance walked in meters after 6 minutes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Baseline and after acclimation period (30-90 days after fitting)
Results posted on
2021-10-14
Participant Flow
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.
Participant milestones
| Measure |
C-Leg 3, Then C-Leg 4
The participants were first fitted with C-Leg 3 and allowed to accommodate for up to 90 days after which they were assessed. Then they crossed over to be fitted with the C-Leg 4 and allowed to accommodate for 30 days after which they were assessed.
|
C-Leg 4, Then C-Leg 3
The participants were first fitted with C-Leg 4 and allowed to accommodate for up to 90 days after which they were assessed. Then they crossed over to be fitted with the C-Leg 3 and allowed to accommodate for 30 days after which they were assessed.
|
|---|---|---|
|
First Intervention (90 Days)
STARTED
|
5
|
8
|
|
First Intervention (90 Days)
COMPLETED
|
4
|
7
|
|
First Intervention (90 Days)
NOT COMPLETED
|
1
|
1
|
|
Second Intervention (30 Days)
STARTED
|
4
|
7
|
|
Second Intervention (30 Days)
COMPLETED
|
2
|
5
|
|
Second Intervention (30 Days)
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
C-Leg 3, Then C-Leg 4
The participants were first fitted with C-Leg 3 and allowed to accommodate for up to 90 days after which they were assessed. Then they crossed over to be fitted with the C-Leg 4 and allowed to accommodate for 30 days after which they were assessed.
|
C-Leg 4, Then C-Leg 3
The participants were first fitted with C-Leg 4 and allowed to accommodate for up to 90 days after which they were assessed. Then they crossed over to be fitted with the C-Leg 3 and allowed to accommodate for 30 days after which they were assessed.
|
|---|---|---|
|
First Intervention (90 Days)
Adverse Event
|
1
|
1
|
|
Second Intervention (30 Days)
Protocol Violation
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
C-Leg 3, Then C-Leg 4
n=5 Participants
C-Leg 4: Microprocessor Controlled Knee
C-Leg 3: Microprocessor Controlled Knee
|
C-Leg 4, Then C-Leg 3
n=8 Participants
C-Leg 4: Microprocessor Controlled Knee
C-Leg 3: Microprocessor Controlled Knee
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 4.95 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 12.2 • n=8 Participants
|
60.6 years
STANDARD_DEVIATION 10.2 • n=13 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=8 Participants
|
9 Participants
n=13 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Austria
|
2 participants
n=5 Participants
|
2 participants
n=8 Participants
|
5 participants
n=13 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=5 Participants
|
6 participants
n=8 Participants
|
8 participants
n=13 Participants
|
|
Height
|
177.4 cm
STANDARD_DEVIATION 7.54 • n=5 Participants
|
172.13 cm
STANDARD_DEVIATION 9.40 • n=8 Participants
|
174.15 cm
STANDARD_DEVIATION 8.81 • n=13 Participants
|
|
Weight
|
74.4 kg
STANDARD_DEVIATION 12.4 • n=5 Participants
|
73.9 kg
STANDARD_DEVIATION 14.4 • n=8 Participants
|
74.1 kg
STANDARD_DEVIATION 13.1 • n=13 Participants
|
|
Time since amputation
|
21.8 years
STANDARD_DEVIATION 23.6 • n=5 Participants
|
23.0 years
STANDARD_DEVIATION 14.9 • n=8 Participants
|
22.54 years
STANDARD_DEVIATION 17.74 • n=13 Participants
|
|
Amputation side
left
|
1 Participants
n=5 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=13 Participants
|
|
Amputation side
right
|
4 Participants
n=5 Participants
|
5 Participants
n=8 Participants
|
9 Participants
n=13 Participants
|
|
Amputation type
Transfemoral
|
0 Participants
n=5 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=13 Participants
|
|
Amputation type
Knee disarticulation
|
5 Participants
n=5 Participants
|
4 Participants
n=8 Participants
|
9 Participants
n=13 Participants
|
|
Medicare Functional Classification Level (MFCL)
2
|
1 Participants
n=5 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=13 Participants
|
|
Medicare Functional Classification Level (MFCL)
3
|
4 Participants
n=5 Participants
|
6 Participants
n=8 Participants
|
10 Participants
n=13 Participants
|
|
Medicare Functional Classification Level (MFCL)
4
|
0 Participants
n=5 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=13 Participants
|
|
Current knee prosthesis (NMPK)
3R106
|
1 Participants
n=5 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=13 Participants
|
|
Current knee prosthesis (NMPK)
3R15
|
0 Participants
n=5 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=13 Participants
|
|
Current knee prosthesis (NMPK)
3R60
|
2 Participants
n=5 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=13 Participants
|
|
Current knee prosthesis (NMPK)
3R80
|
2 Participants
n=5 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=13 Participants
|
|
Current knee prosthesis (NMPK)
Polycentric
|
0 Participants
n=5 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=13 Participants
|
|
Current knee prosthesis (NMPK)
Multiaxial
|
0 Participants
n=5 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=13 Participants
|
|
Amputation cause
cancer
|
1 Participants
n=5 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=13 Participants
|
|
Amputation cause
infection
|
1 Participants
n=5 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=13 Participants
|
|
Amputation cause
trauma
|
1 Participants
n=5 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=13 Participants
|
|
Amputation cause
vascular disease
|
2 Participants
n=5 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=13 Participants
|
|
Hours of wearing prosthesis per day
|
12.4 hours
STANDARD_DEVIATION 2.6 • n=5 Participants
|
12.4 hours
STANDARD_DEVIATION 2.7 • n=8 Participants
|
12.4 hours
STANDARD_DEVIATION 2.6 • n=13 Participants
|
|
Distance covered per day
|
3.6 km
STANDARD_DEVIATION 2.1 • n=5 Participants
|
3.25 km
STANDARD_DEVIATION 1.5 • n=8 Participants
|
3.38 km
STANDARD_DEVIATION 1.7 • n=13 Participants
|
PRIMARY outcome
Timeframe: Baseline and after acclimation period (30-90 days after fitting)A measure of walking endurance, the distance walked in meters after 6 minutes.
Outcome measures
| Measure |
C-Leg 3
n=7 Participants
The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
C-Leg 4
n=7 Participants
The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
|---|---|---|
|
Change in 6 Minute Gait Test
Baseline
|
380.4 meters
Standard Deviation 69.66
|
380.4 meters
Standard Deviation 69.66
|
|
Change in 6 Minute Gait Test
Change from Baseline after accommodation
|
35.9 meters
Standard Deviation 20.26
|
26.7 meters
Standard Deviation 33.87
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
C-Leg 3
n=7 Participants
The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
C-Leg 4
n=7 Participants
The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
|---|---|---|
|
Change in 10 Meter Gait Test
SSWS at Baseline
|
1.11 meters per second
Standard Deviation 0.168
|
1.11 meters per second
Standard Deviation 0.168
|
|
Change in 10 Meter Gait Test
SSWS after acclimation
|
0.00 meters per second
Standard Deviation 0.06
|
-0.25 meters per second
Standard Deviation 0.14
|
|
Change in 10 Meter Gait Test
FWS at Baseline
|
1.36 meters per second
Standard Deviation 0.262
|
1.36 meters per second
Standard Deviation 0.262
|
|
Change in 10 Meter Gait Test
FWS after acclimation
|
0.21 meters per second
Standard Deviation 0.15
|
-0.03 meters per second
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
C-Leg 3
n=7 Participants
The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
C-Leg 4
n=7 Participants
The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
|---|---|---|
|
Change in Stairs Assessment Index (SAI)
Baseline SAI (Descent)
|
4 score on a scale
Standard Deviation 1.6
|
4 score on a scale
Standard Deviation 1.6
|
|
Change in Stairs Assessment Index (SAI)
Baseline SAI (Ascent)
|
5 score on a scale
Standard Deviation 2.6
|
5 score on a scale
Standard Deviation 2.6
|
|
Change in Stairs Assessment Index (SAI)
Change in SAI (Ascent) after fitting and acclimation
|
-0.6 score on a scale
Standard Deviation 1.5
|
0.0 score on a scale
Standard Deviation 0.0
|
|
Change in Stairs Assessment Index (SAI)
Change in SAI (Descent) after fitting and acclimation
|
5.9 score on a scale
Standard Deviation 3.2
|
5.7 score on a scale
Standard Deviation 2.9
|
|
Change in Stairs Assessment Index (SAI)
Baseline time to descent stairs
|
12.7 score on a scale
Standard Deviation 3.95
|
12.7 score on a scale
Standard Deviation 3.95
|
|
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
|
-3.1 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
C-Leg 3
n=7 Participants
The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
C-Leg 4
n=7 Participants
The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
|---|---|---|
|
Change in Hill Assessment Index (HAI)
Baseline HAI (Ascent)
|
8.4 score on a scale
Standard Deviation 2.5
|
8.4 score on a scale
Standard Deviation 2.5
|
|
Change in Hill Assessment Index (HAI)
Change in HAI (Ascent) after fitting and acclimation
|
1.9 score on a scale
Standard Deviation 2.0
|
1.1 score on a scale
Standard Deviation 1.3
|
|
Change in Hill Assessment Index (HAI)
Baseline HAI (Descent)
|
7.9 score on a scale
Standard Deviation 2.8
|
7.9 score on a scale
Standard Deviation 2.8
|
|
Change in Hill Assessment Index (HAI)
Change in HAI (Descent) after fitting and acclimation
|
1.9 score on a scale
Standard Deviation 2.0
|
0.9 score on a scale
Standard Deviation 2.7
|
|
Change in Hill Assessment Index (HAI)
Baseline Descent Time
|
6.6 score on a scale
Standard Deviation 2.5
|
6.6 score on a scale
Standard Deviation 2.5
|
|
Change in Hill Assessment Index (HAI)
Change in Descent Time after fitting and acclimation
|
-0.9 score on a scale
Standard Deviation 1.3
|
-0.4 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
C-Leg 3
n=7 Participants
The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
C-Leg 4
n=7 Participants
The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
|---|---|---|
|
Change in Four Step Square Test (FSST)
FSST after fitting and acclimation
|
-2.6 seconds
Standard Deviation 1.18
|
-2.4 seconds
Standard Deviation 1.77
|
|
Change in Four Step Square Test (FSST)
Baseline FSST
|
13.5 seconds
Standard Deviation 3.92
|
13.5 seconds
Standard Deviation 3.92
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
C-Leg 3
n=7 Participants
The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
C-Leg 4
n=7 Participants
The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
|---|---|---|
|
Change in Activities-specific Balance Confidence (ABC) Scale
Baseline ABC
|
72.4 score on a scale
Standard Deviation 9.73
|
72.4 score on a scale
Standard Deviation 9.73
|
|
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
|
2.7 score on a scale
Standard Deviation 8.75
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
C-Leg 3
n=7 Participants
The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
C-Leg 4
n=7 Participants
The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
|---|---|---|
|
Change in Prosthetic Limb Users Survey of Mobility (PLUS-M)
Baseline PLUS-M T-Score
|
50.0 T-score
Standard Deviation 6.64
|
50 T-score
Standard Deviation 6.64
|
|
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
|
0.8 T-score
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
C-Leg 3
n=7 Participants
The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
C-Leg 4
n=7 Participants
The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
|---|---|---|
|
Change in Amputee Body Image Scale (ABIS)
Baseline ABIS
|
55.1 score on a scale
Standard Deviation 13.01
|
55.1 score on a scale
Standard Deviation 13.01
|
|
Change in Amputee Body Image Scale (ABIS)
Change in ABIS after fitting and acclimation
|
1.9 score on a scale
Standard Deviation 7.34
|
-0.4 score on a scale
Standard Deviation 6.97
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
C-Leg 3
n=7 Participants
The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
C-Leg 4
n=7 Participants
The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
|---|---|---|
|
Change in Number of Stumbles and Falls
Baseline number of stumbles
|
3.3 number of stumbles or falls
Standard Deviation 4.07
|
3.3 number of stumbles or falls
Standard Deviation 4.07
|
|
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
|
-0.3 number of stumbles or falls
Standard Deviation 2.29
|
|
Change in Number of Stumbles and Falls
Baseline number of falls
|
1.0 number of stumbles or falls
Standard Deviation 1.53
|
1.0 number of stumbles or falls
Standard Deviation 1.53
|
|
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
|
-0.1 number of stumbles or falls
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: At 3rd study visit after having been fitted and acclimatized to each of the study devicesPopulation: All subjects with preference data that completed the study were included in the analysis.
The user´s knee preference is assessed with the question: "Which prosthesis do you prefer?"
Outcome measures
| Measure |
C-Leg 3
n=11 Participants
The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
C-Leg 4
The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
|---|---|---|
|
Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee)
Number preferring the C-Leg 4
|
7 Participants
|
—
|
|
Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee)
Number preferring the C-Leg 3
|
3 Participants
|
—
|
|
Preference of the Knee (Percentage of Subjects That Preferred Each Studied Knee)
Number preferring the NMPK
|
1 Participants
|
—
|
Adverse Events
C-Leg 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
C-Leg 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
C-Leg 3
n=13 participants at risk
The participants wearing a C-Leg 3 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
C-Leg 4
n=13 participants at risk
The participants wearing a C-Leg 4 either in the first fitting (after max 90 days of acclimation) or the second fitting (after 30 days acclimation)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
7.7%
1/13 • Number of events 1 • 36-40 weeks
|
0.00%
0/13 • 36-40 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.7%
1/13 • Number of events 1 • 36-40 weeks
|
0.00%
0/13 • 36-40 weeks
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
0.00%
0/13 • 36-40 weeks
|
7.7%
1/13 • Number of events 1 • 36-40 weeks
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
0.00%
0/13 • 36-40 weeks
|
7.7%
1/13 • Number of events 1 • 36-40 weeks
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/13 • 36-40 weeks
|
7.7%
1/13 • Number of events 1 • 36-40 weeks
|
|
Musculoskeletal and connective tissue disorders
Residual limb pain
|
7.7%
1/13 • Number of events 1 • 36-40 weeks
|
0.00%
0/13 • 36-40 weeks
|
Additional Information
Director of Clinical Research and Services Vienna
Otto Bock Healthcare GmbH
Phone: +4315233786733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60