Trial Outcomes & Findings for Assessment of Disability Compensation With the C-LEG COMPACT 2 Knee (Ref. 3C60 et 3C60=ST) (NCT NCT02382991)
NCT ID: NCT02382991
Last Updated: 2019-10-23
Results Overview
This test consists of recording the amount of time needed for a person to stand up from a chair, walk 3 metres, make a half-turn and sit down again. The TGUG test score reflects a person's balance and as a consequence, the risk of falling.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK
Results posted on
2019-10-23
Participant Flow
Participant milestones
| Measure |
NMPK (30 Days), 3C60 (90 Days)
D0 + 30 days: evaluation with the non-microprocessor knee. D1 + 90 days: evaluation with the 3C60 knee.
3C60-NMPK: 3 months with 3C60 - 10 days wash out - 1 month with NMPK
|
3C60 (90 Days), Washout (10 Days), NMPK (30 Days)
D0 + 90 days: evaluation with the 3C60 knee. A period of 10 days of "wash out". D1 + 30 days: evaluation with the non-microprocessor knee.
NMPK-3C60: 1 month with NMPK - 3 months with 3C60
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
NMPK (30 Days), 3C60 (90 Days)
D0 + 30 days: evaluation with the non-microprocessor knee. D1 + 90 days: evaluation with the 3C60 knee.
3C60-NMPK: 3 months with 3C60 - 10 days wash out - 1 month with NMPK
|
3C60 (90 Days), Washout (10 Days), NMPK (30 Days)
D0 + 90 days: evaluation with the 3C60 knee. A period of 10 days of "wash out". D1 + 30 days: evaluation with the non-microprocessor knee.
NMPK-3C60: 1 month with NMPK - 3 months with 3C60
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Assessment of Disability Compensation With the C-LEG COMPACT 2 Knee (Ref. 3C60 et 3C60=ST)
Baseline characteristics by cohort
| Measure |
Group NMPK Then 3C60
n=17 Participants
This arm group includes 17 participants who were first fitted with Non MicroProcessor-controlled Knee (30 days) then with 3C60 knee (90 days).
|
Group 3C60 Then NMPK
n=18 Participants
This arm group includes 18 participants who were first fitted with 3C60 knee (90 days) then had a washout period (10 days) then where fitted with Non MicroProcessor-controlled Kne (30 days).
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.94 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
63.28 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
65.06 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
76.5 Percentage of participants
n=5 Participants
|
77.8 Percentage of participants
n=7 Participants
|
77.1 Percentage of participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
23.5 Percentage of participants
n=5 Participants
|
22.2 Percentage of participants
n=7 Participants
|
22.9 Percentage of participants
n=5 Participants
|
|
Amputation cause
Vascular
|
35.3 Percentage of participants
n=5 Participants
|
55.6 Percentage of participants
n=7 Participants
|
45.7 Percentage of participants
n=5 Participants
|
|
Amputation cause
Vascular diabetic
|
11.8 Percentage of participants
n=5 Participants
|
11.1 Percentage of participants
n=7 Participants
|
11.4 Percentage of participants
n=5 Participants
|
|
Amputation cause
Traumatic
|
23.5 Percentage of participants
n=5 Participants
|
22.2 Percentage of participants
n=7 Participants
|
22.9 Percentage of participants
n=5 Participants
|
|
Amputation cause
Tumour
|
11.8 Percentage of participants
n=5 Participants
|
11.1 Percentage of participants
n=7 Participants
|
11.4 Percentage of participants
n=5 Participants
|
|
Amputation cause
Infectious
|
17.6 Percentage of participants
n=5 Participants
|
0 Percentage of participants
n=7 Participants
|
8.6 Percentage of participants
n=5 Participants
|
|
Amputation level
Transfemoral
|
94.1 Percentage of participants
n=5 Participants
|
94.4 Percentage of participants
n=7 Participants
|
94.3 Percentage of participants
n=5 Participants
|
|
Amputation level
Knee disarticulation
|
5.9 Percentage of participants
n=5 Participants
|
5.6 Percentage of participants
n=7 Participants
|
5.7 Percentage of participants
n=5 Participants
|
|
Weight
|
76.1 Kg
STANDARD_DEVIATION 16.6 • n=5 Participants
|
76.2 Kg
STANDARD_DEVIATION 16.2 • n=7 Participants
|
76.1 Kg
STANDARD_DEVIATION 16.1 • n=5 Participants
|
|
Height
|
170.3 cm
STANDARD_DEVIATION 10.2 • n=5 Participants
|
172.3 cm
STANDARD_DEVIATION 7.7 • n=7 Participants
|
171.3 cm
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Time since amputation
|
51.3 months
STANDARD_DEVIATION 62.1 • n=5 Participants
|
70.8 months
STANDARD_DEVIATION 105.1 • n=7 Participants
|
61.4 months
STANDARD_DEVIATION 85.5 • n=5 Participants
|
|
International Classification of Function (ICF)
d4602
|
94.1 Percentage of participants
n=5 Participants
|
88.9 Percentage of participants
n=7 Participants
|
91.4 Percentage of participants
n=5 Participants
|
|
International Classification of Function (ICF)
d4601
|
5.9 Percentage of participants
n=5 Participants
|
11.1 Percentage of participants
n=7 Participants
|
8.6 Percentage of participants
n=5 Participants
|
|
Additional disabilities
Trans-tibial amputation of the controlateral lower
|
2.9 Percentage of participants
n=5 Participants
|
11.1 Percentage of participants
n=7 Participants
|
8.6 Percentage of participants
n=5 Participants
|
|
Additional disabilities
forefoot amputation on the controlateral side
|
2.9 Percentage of participants
n=5 Participants
|
0 Percentage of participants
n=7 Participants
|
2.9 Percentage of participants
n=5 Participants
|
|
Additional disabilities
Handicap of the upper limbs
|
0 Percentage of participants
n=5 Participants
|
11.1 Percentage of participants
n=7 Participants
|
5.7 Percentage of participants
n=5 Participants
|
|
Additional disabilities
Traumatism of the controlateral lower limb
|
2.9 Percentage of participants
n=5 Participants
|
0 Percentage of participants
n=7 Participants
|
2.9 Percentage of participants
n=5 Participants
|
|
Additional disabilities
Hemiplegia after a stroke affecting balance
|
0 Percentage of participants
n=5 Participants
|
5.6 Percentage of participants
n=7 Participants
|
2.9 Percentage of participants
n=5 Participants
|
|
Geographical area
Urban
|
70.6 Percentage of participants
n=5 Participants
|
66.7 Percentage of participants
n=7 Participants
|
68.6 Percentage of participants
n=5 Participants
|
|
Geographical area
Rural
|
29.4 Percentage of participants
n=5 Participants
|
33.3 Percentage of participants
n=7 Participants
|
31.4 Percentage of participants
n=5 Participants
|
|
work status
With a professional activity
|
0 Percentage of participants
n=5 Participants
|
11.1 Percentage of participants
n=7 Participants
|
5.7 Percentage of participants
n=5 Participants
|
|
work status
Without activity
|
23.5 Percentage of participants
n=5 Participants
|
22.2 Percentage of participants
n=7 Participants
|
22.9 Percentage of participants
n=5 Participants
|
|
work status
Retired
|
76.5 Percentage of participants
n=5 Participants
|
66.7 Percentage of participants
n=7 Participants
|
71.4 Percentage of participants
n=5 Participants
|
|
previous prosthesis
Locked knee
|
29.4 Percentage of participants
n=5 Participants
|
38.9 Percentage of participants
n=7 Participants
|
34.3 Percentage of participants
n=5 Participants
|
|
previous prosthesis
Brake knee
|
17.6 Percentage of participants
n=5 Participants
|
16.7 Percentage of participants
n=7 Participants
|
17.1 Percentage of participants
n=5 Participants
|
|
previous prosthesis
Pneumatic knee
|
17.6 Percentage of participants
n=5 Participants
|
5.6 Percentage of participants
n=7 Participants
|
11.4 Percentage of participants
n=5 Participants
|
|
previous prosthesis
Hydraulic knee
|
29.4 Percentage of participants
n=5 Participants
|
33.3 Percentage of participants
n=7 Participants
|
31.4 Percentage of participants
n=5 Participants
|
|
previous prosthesis
Free knee
|
5.9 Percentage of participants
n=5 Participants
|
5.6 Percentage of participants
n=7 Participants
|
5.7 Percentage of participants
n=5 Participants
|
|
socket type
Quadrangular
|
0 Percentage of participants
n=5 Participants
|
5.6 Percentage of participants
n=7 Participants
|
2.9 Percentage of participants
n=5 Participants
|
|
socket type
With ischial containment
|
88.2 Percentage of participants
n=5 Participants
|
88.9 Percentage of participants
n=7 Participants
|
88.6 Percentage of participants
n=5 Participants
|
|
socket type
For knee disarticulation
|
5.9 Percentage of participants
n=5 Participants
|
5.6 Percentage of participants
n=7 Participants
|
5.7 Percentage of participants
n=5 Participants
|
|
prosthetic foot with mechanical knee
Dynamic with carbon
|
41.2 Percentage of participants
n=5 Participants
|
50.0 Percentage of participants
n=7 Participants
|
45.7 Percentage of participants
n=5 Participants
|
|
prosthetic foot with mechanical knee
Dynamic without carbon
|
29.4 Percentage of participants
n=5 Participants
|
22.2 Percentage of participants
n=7 Participants
|
25.7 Percentage of participants
n=5 Participants
|
|
prosthetic foot with mechanical knee
Articulated
|
17.6 Percentage of participants
n=5 Participants
|
16.7 Percentage of participants
n=7 Participants
|
17.1 Percentage of participants
n=5 Participants
|
|
prosthetic foot with mechanical knee
Solid Ankle Cushion Heel (SACH)
|
11.8 Percentage of participants
n=5 Participants
|
11.1 Percentage of participants
n=7 Participants
|
11.4 Percentage of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPKThis test consists of recording the amount of time needed for a person to stand up from a chair, walk 3 metres, make a half-turn and sit down again. The TGUG test score reflects a person's balance and as a consequence, the risk of falling.
Outcome measures
| Measure |
Overall
n=30 Participants
|
|---|---|
|
Timed Get Up and Go (TGUG)
NMPK
|
24.8 seconds
Standard Deviation 8.3
|
|
Timed Get Up and Go (TGUG)
3C60
|
21.6 seconds
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPKThe Locomotor Capabilities Index (LCI-5) is a 14 item self-assessment questionnaire filled in by the patient that explores walking and ambulation. The LCI-5 is derived from the Prosthesis Profile of the Amputee Questionnaire (PPA). LCI-5 is sensitive to the use of walking aids or to the need of a third party. Ceiling effect is not expected with moderately active amputees. The global LCI-5 score is the addition of the 14 scores, noted between 0 and 4. The global score varies between 0 and 56, the highest being for persons with high locomotors capabilities. LCI-5 has two sub-scores: the basic score corresponds to 7 questions related to basic activities and the advanced score corresponds to 7 questions related to more advanced activities. The basic and advanced scores both range from 0-28. Higher scores correspond with a better outcome.
Outcome measures
| Measure |
Overall
n=30 Participants
|
|---|---|
|
Locomotor Capabilities Index (LCI-5)
NMPK - Global score
|
38.6 Score between 0 and 56
Standard Deviation 9.5
|
|
Locomotor Capabilities Index (LCI-5)
3C60 - Global score
|
41.7 Score between 0 and 56
Standard Deviation 7.3
|
|
Locomotor Capabilities Index (LCI-5)
NMPK - Basic score
|
20.1 Score between 0 and 56
Standard Deviation 4.8
|
|
Locomotor Capabilities Index (LCI-5)
3C60 - Basic score
|
21.9 Score between 0 and 56
Standard Deviation 3.8
|
|
Locomotor Capabilities Index (LCI-5)
NMPK - Advances score
|
18.5 Score between 0 and 56
Standard Deviation 5.5
|
|
Locomotor Capabilities Index (LCI-5)
3C60 - Advanced score
|
19.8 Score between 0 and 56
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPKPopulation: No significant difference in the repartition of walking aids was - a priori- expected between both devices: NMPK and 3C60.
The type of walking aids used with each device will be recorded.
Outcome measures
| Measure |
Overall
n=30 Participants
|
|---|---|
|
Use of Walking Aids
NMPK - 2 crutches
|
9 participants
|
|
Use of Walking Aids
3C60 - 2 crutches
|
8 participants
|
|
Use of Walking Aids
NMPK - none
|
7 participants
|
|
Use of Walking Aids
3C60 - none
|
7 participants
|
|
Use of Walking Aids
NMPK - 1 cane
|
7 participants
|
|
Use of Walking Aids
3C60 - 1 cane
|
7 participants
|
|
Use of Walking Aids
NMPK - 1 crutch
|
3 participants
|
|
Use of Walking Aids
3C60 - 1 crutch
|
5 participants
|
|
Use of Walking Aids
NMPK - 2 canes
|
3 participants
|
|
Use of Walking Aids
3C60 - 2 canes
|
3 participants
|
|
Use of Walking Aids
NMPK - Walking frame
|
1 participants
|
|
Use of Walking Aids
3C60 - walking frame
|
0 participants
|
SECONDARY outcome
Timeframe: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPKIt is a self-evaluation questionnaire of the user's satisfaction, translated in French (ESAT) and in German (QUEST 2.0-G Section 17.5). The QUEST 2.0 questionnaire contains 8 items that evaluate the device's technology and 4 items that evaluate services surrounding the device. It allows patients to express themselves on the criteria that are most important to them. Each item has a score that varies between 0 (not satisfied at all) and 5 (very satisfied). The global score is the average obtained onto the 12 items. Two sub-scores related to the technology and services can also be calculated. They correspond to the average of the 8 first items and to the 4 last items respectively. All scores ranks between 0 and 5, 5 being the highest level of satisfaction.
Outcome measures
| Measure |
Overall
n=30 Participants
|
|---|---|
|
QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)
NMPK - Global score
|
3.7 Score from 0 to 5
Standard Deviation 0.8
|
|
QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)
3C60 - Global score
|
4.4 Score from 0 to 5
Standard Deviation 1.0
|
|
QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)
NMPK - Services
|
4.1 Score from 0 to 5
Standard Deviation 0.7
|
|
QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)
3C60 - Services
|
4.5 Score from 0 to 5
Standard Deviation 1.1
|
|
QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)
NMPK - Technology
|
3.7 Score from 0 to 5
Standard Deviation 0.8
|
|
QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)
3C60 - Technology
|
4.3 Score from 0 to 5
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK36-Item Short Form Health Survey (SF-36v2TM) explores 8 dimensions of quality of life through 36 questions: PF= Physical Functioning (10 items), RP= Role Physical (4 items), BP = Bodily Pain (2 items), SF= Social Functioning (2 items), MH= Mental Health (5 items), RE= Role emotional (3 items), VT= Vitality (4 items), GH= General Health (5 items). All of the eight health domain scales contributes with different levels to score two component summary measures: PCS= Physical Component Summary and MCS= Mental Component Summary. All scores are calculated online through scoring software. Domain scales and component summary are ranging from 0 to 100. A high score is considered to be a better outcome, as indicating little or no problem.
Outcome measures
| Measure |
Overall
n=30 Participants
|
|---|---|
|
SF-36v2™ Health Survey
NMPK - Physical Component Score
|
43.1 scores on a scale
Standard Deviation 6.7
|
|
SF-36v2™ Health Survey
3C60 - Physical Component Score
|
45.0 scores on a scale
Standard Deviation 8.4
|
|
SF-36v2™ Health Survey
NMPK - Mental Component Score
|
56.6 scores on a scale
Standard Deviation 9.7
|
|
SF-36v2™ Health Survey
3C60 - Mental Ccomponent Score
|
56.0 scores on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Measurement will be performed at 1 month with both devicesOutcome measures
| Measure |
Overall
n=30 Participants
|
|---|---|
|
Number of Falls
NMPK - number of falls occured
|
6 falls
|
|
Number of Falls
3C60 - number of falls occured
|
1 falls
|
|
Number of Falls
NMPK - number related to the knee
|
4 falls
|
|
Number of Falls
3C60 - number related to the knee
|
0 falls
|
Adverse Events
NMPK
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
3C60
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NMPK
n=35 participants at risk
Participants with non microprocessor-controlled knee joint
|
3C60
n=35 participants at risk
Participants with 3C60 knee joint
|
|---|---|---|
|
Surgical and medical procedures
Hospitalization due to other reason than amputation
|
2.9%
1/35 • Number of events 1
|
0.00%
0/35
|
Other adverse events
| Measure |
NMPK
n=35 participants at risk
Participants with non microprocessor-controlled knee joint
|
3C60
n=35 participants at risk
Participants with 3C60 knee joint
|
|---|---|---|
|
Social circumstances
Non serious adverse events related to the knee
|
5.7%
2/35 • Number of events 4
|
5.7%
2/35 • Number of events 2
|
|
Social circumstances
Non serious adverse events maybe related to the knee
|
0.00%
0/35
|
8.6%
3/35 • Number of events 3
|
|
Social circumstances
Non serious adverse events not related to the knee
|
0.00%
0/35
|
14.3%
5/35 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place