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Assessment of Disability Compensation With the C-LEG COMPACT 2 Knee (Ref. 3C60 et 3C60=ST)

Randomized, Cross-over Study Comparing the Efficacy of the 3C60 Knee Against Non-microprocessor Controlled Knees on the Risk of Falling and Locomotor Skills of Moderately Active Persons With Leg Amputation Above Knee or Knee Disarticulation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02382991
Enrollment
35
Registered
2015-03-09
Start date
2015-03-31
Completion date
2015-11-30
Last updated
2019-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation of Hip and Thigh, Level Unspecified

Keywords

Moderately active amputees, C-leg Compact, Knee prosthesis, Kenevo, Microprocessor controlled knee, Amputation, 3C60, Timed Get Up and Go (TGUG), Locomotors Capacities Index (LCI), QUEST, Short Form survey (SF-36)

Brief summary

Moderately active amputees may have lost their limb due to diabetes, vascular conditions, trauma, tumour or congenital causes. These amputees currently cannot benefit from having a computerised knee because of the performance criteria associated with being given one. However, these amputees have a very high risk of falling because they use a non microprocessor controlled knee joint (NMPK) and because their physical ability, associated disability and persistent contralateral leg weakness do not allow them to compensate for a balance deficit. These amputees restrict how much they move around and their participation because of their instability and elevated risk of falling. The objective of the study is to evaluate the effect of the 3C60 knee, a microprocessor-controlled knee joint for external leg prosthesis, on the reduction in the risk of falling after three months in moderately active persons with leg amputation above knee or knee disarticulation.

Detailed description

The patient will be evaluated after one month of using his/her usual non micropressor controlled knee joint (NMPK). After fitting of the 3C60, the patient will undergo at least five rehabilitation sessions, adapted to his/her individual needs, so that he/she knows how to use the device and is ready to go along with the planned testing. After the trial with the 3C60 knee, the patient will again be fitted with his/her non microprocessor controlled knee joint (NMPK) and will be required to undergo one rehabilitation session to regain his/her walking abilities.

Interventions

DEVICE3C60-NMPK

3 months with 3C60 - 10 days wash out - 1 month with NMPK

DEVICENMPK-3C60

1 month with NMPK - 3 months with 3C60

Sponsors

Otto Bock France SNC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Person with leg amputation above knee or knee disarticulation with stabilized residual limb * Person who are currently fitted with a prosthesis using a non-microprocessor controlled prosthetic knee * Person with a high risk of falling, which is defined as a TGUG test score of more than 19 seconds * Person who moves around within buildings other than one's residence, such as moving around other people's homes, other private buildings, community and private or public buildings and enclosed areas, moving throughout all parts of buildings and enclosed areas, between floors, inside, outside and around buildings, both public and private * Person who moves around outside the home and other buildings, such as walking and moving around close to or far from one's home and other buildings, without the use of transportation, public or private, such as walking for short or long distances around a town or village, walking or moving down streets in the neighbourhood, town, village or city; moving between cities and further distances, without using transportation * Person with a daily walking distance greater than 300 m

Exclusion criteria

* Persons using underarm crutches or walkers * Persons under 18 years of age * Persons who weigh more than 125 kg * Pregnant women * Persons in an emergency situation * Persons who cannot personally provide their consent * Persons who are not available to follow the entire study protocol

Design outcomes

Primary

MeasureTime frameDescription
Timed Get Up and Go (TGUG)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.

Secondary

MeasureTime frameDescription
Locomotor Capabilities Index (LCI-5)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.
Use of Walking AidsMeasurement will be performed at 3 months with 3C60 and at 1 month with NMPKThe type of walking aids used with each device will be recorded.
QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)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.
SF-36v2™ Health SurveyMeasurement 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.
Number of FallsMeasurement will be performed at 1 month with both devices

Countries

Austria, France, Germany

Participant flow

Participants by arm

ArmCount
Group NMPK Then 3C60
This arm group includes 17 participants who were first fitted with Non MicroProcessor-controlled Knee (30 days) then with 3C60 knee (90 days).
17
Group 3C60 Then NMPK
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).
18
Total35

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event12
Overall StudyLost to Follow-up10
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicTotalGroup NMPK Then 3C60Group 3C60 Then NMPK
Additional disabilities
forefoot amputation on the controlateral side
2.9 Percentage of participants2.9 Percentage of participants0 Percentage of participants
Additional disabilities
Handicap of the upper limbs
5.7 Percentage of participants0 Percentage of participants11.1 Percentage of participants
Additional disabilities
Hemiplegia after a stroke affecting balance
2.9 Percentage of participants0 Percentage of participants5.6 Percentage of participants
Additional disabilities
Trans-tibial amputation of the controlateral lower
8.6 Percentage of participants2.9 Percentage of participants11.1 Percentage of participants
Additional disabilities
Traumatism of the controlateral lower limb
2.9 Percentage of participants2.9 Percentage of participants0 Percentage of participants
Age, Continuous65.06 years
STANDARD_DEVIATION 10.1
66.94 years
STANDARD_DEVIATION 9.6
63.28 years
STANDARD_DEVIATION 10.5
Amputation cause
Infectious
8.6 Percentage of participants17.6 Percentage of participants0 Percentage of participants
Amputation cause
Traumatic
22.9 Percentage of participants23.5 Percentage of participants22.2 Percentage of participants
Amputation cause
Tumour
11.4 Percentage of participants11.8 Percentage of participants11.1 Percentage of participants
Amputation cause
Vascular
45.7 Percentage of participants35.3 Percentage of participants55.6 Percentage of participants
Amputation cause
Vascular diabetic
11.4 Percentage of participants11.8 Percentage of participants11.1 Percentage of participants
Amputation level
Knee disarticulation
5.7 Percentage of participants5.9 Percentage of participants5.6 Percentage of participants
Amputation level
Transfemoral
94.3 Percentage of participants94.1 Percentage of participants94.4 Percentage of participants
Geographical area
Rural
31.4 Percentage of participants29.4 Percentage of participants33.3 Percentage of participants
Geographical area
Urban
68.6 Percentage of participants70.6 Percentage of participants66.7 Percentage of participants
Height171.3 cm
STANDARD_DEVIATION 8.6
170.3 cm
STANDARD_DEVIATION 10.2
172.3 cm
STANDARD_DEVIATION 7.7
International Classification of Function (ICF)
d4601
8.6 Percentage of participants5.9 Percentage of participants11.1 Percentage of participants
International Classification of Function (ICF)
d4602
91.4 Percentage of participants94.1 Percentage of participants88.9 Percentage of participants
previous prosthesis
Brake knee
17.1 Percentage of participants17.6 Percentage of participants16.7 Percentage of participants
previous prosthesis
Free knee
5.7 Percentage of participants5.9 Percentage of participants5.6 Percentage of participants
previous prosthesis
Hydraulic knee
31.4 Percentage of participants29.4 Percentage of participants33.3 Percentage of participants
previous prosthesis
Locked knee
34.3 Percentage of participants29.4 Percentage of participants38.9 Percentage of participants
previous prosthesis
Pneumatic knee
11.4 Percentage of participants17.6 Percentage of participants5.6 Percentage of participants
prosthetic foot with mechanical knee
Articulated
17.1 Percentage of participants17.6 Percentage of participants16.7 Percentage of participants
prosthetic foot with mechanical knee
Dynamic with carbon
45.7 Percentage of participants41.2 Percentage of participants50.0 Percentage of participants
prosthetic foot with mechanical knee
Dynamic without carbon
25.7 Percentage of participants29.4 Percentage of participants22.2 Percentage of participants
prosthetic foot with mechanical knee
Solid Ankle Cushion Heel (SACH)
11.4 Percentage of participants11.8 Percentage of participants11.1 Percentage of participants
Sex/Gender, Customized
Female
22.9 Percentage of participants23.5 Percentage of participants22.2 Percentage of participants
Sex/Gender, Customized
Male
77.1 Percentage of participants76.5 Percentage of participants77.8 Percentage of participants
socket type
For knee disarticulation
5.7 Percentage of participants5.9 Percentage of participants5.6 Percentage of participants
socket type
Quadrangular
2.9 Percentage of participants0 Percentage of participants5.6 Percentage of participants
socket type
With ischial containment
88.6 Percentage of participants88.2 Percentage of participants88.9 Percentage of participants
Time since amputation61.4 months
STANDARD_DEVIATION 85.5
51.3 months
STANDARD_DEVIATION 62.1
70.8 months
STANDARD_DEVIATION 105.1
Weight76.1 Kg
STANDARD_DEVIATION 16.1
76.1 Kg
STANDARD_DEVIATION 16.6
76.2 Kg
STANDARD_DEVIATION 16.2
work status
Retired
71.4 Percentage of participants76.5 Percentage of participants66.7 Percentage of participants
work status
With a professional activity
5.7 Percentage of participants0 Percentage of participants11.1 Percentage of participants
work status
Without activity
22.9 Percentage of participants23.5 Percentage of participants22.2 Percentage of participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
2 / 3510 / 35
serious
Total, serious adverse events
1 / 350 / 35

Outcome results

Primary

Timed Get Up and Go (TGUG)

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.

Time frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK

ArmMeasureGroupValue (MEAN)Dispersion
OverallTimed Get Up and Go (TGUG)NMPK24.8 secondsStandard Deviation 8.3
OverallTimed Get Up and Go (TGUG)3C6021.6 secondsStandard Deviation 9
Secondary

Locomotor Capabilities Index (LCI-5)

The 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.

Time frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK

ArmMeasureGroupValue (MEAN)Dispersion
OverallLocomotor Capabilities Index (LCI-5)NMPK - Advances score18.5 Score between 0 and 56Standard Deviation 5.5
OverallLocomotor Capabilities Index (LCI-5)3C60 - Advanced score19.8 Score between 0 and 56Standard Deviation 5
OverallLocomotor Capabilities Index (LCI-5)NMPK - Global score38.6 Score between 0 and 56Standard Deviation 9.5
OverallLocomotor Capabilities Index (LCI-5)3C60 - Global score41.7 Score between 0 and 56Standard Deviation 7.3
OverallLocomotor Capabilities Index (LCI-5)NMPK - Basic score20.1 Score between 0 and 56Standard Deviation 4.8
OverallLocomotor Capabilities Index (LCI-5)3C60 - Basic score21.9 Score between 0 and 56Standard Deviation 3.8
Secondary

Number of Falls

Time frame: Measurement will be performed at 1 month with both devices

ArmMeasureGroupValue (NUMBER)
OverallNumber of Falls3C60 - number related to the knee0 falls
OverallNumber of FallsNMPK - number of falls occured6 falls
OverallNumber of Falls3C60 - number of falls occured1 falls
OverallNumber of FallsNMPK - number related to the knee4 falls
Secondary

QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)

It 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.

Time frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK

ArmMeasureGroupValue (MEAN)Dispersion
OverallQUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)NMPK - Global score3.7 Score from 0 to 5Standard Deviation 0.8
OverallQUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)NMPK - Services4.1 Score from 0 to 5Standard Deviation 0.7
OverallQUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)3C60 - Services4.5 Score from 0 to 5Standard Deviation 1.1
OverallQUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)NMPK - Technology3.7 Score from 0 to 5Standard Deviation 0.8
OverallQUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)3C60 - Global score4.4 Score from 0 to 5Standard Deviation 1
OverallQUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)3C60 - Technology4.3 Score from 0 to 5Standard Deviation 0.8
Secondary

SF-36v2™ Health Survey

36-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.

Time frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK

ArmMeasureGroupValue (MEAN)Dispersion
OverallSF-36v2™ Health SurveyNMPK - Physical Component Score43.1 scores on a scaleStandard Deviation 6.7
OverallSF-36v2™ Health Survey3C60 - Physical Component Score45.0 scores on a scaleStandard Deviation 8.4
OverallSF-36v2™ Health SurveyNMPK - Mental Component Score56.6 scores on a scaleStandard Deviation 9.7
OverallSF-36v2™ Health Survey3C60 - Mental Ccomponent Score56.0 scores on a scaleStandard Deviation 7.3
Secondary

Use of Walking Aids

The type of walking aids used with each device will be recorded.

Time frame: Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK

Population: No significant difference in the repartition of walking aids was - a priori- expected between both devices: NMPK and 3C60.

ArmMeasureGroupValue (NUMBER)
OverallUse of Walking AidsNMPK - none7 participants
OverallUse of Walking Aids3C60 - none7 participants
OverallUse of Walking AidsNMPK - 1 cane7 participants
OverallUse of Walking Aids3C60 - 1 cane7 participants
OverallUse of Walking AidsNMPK - 1 crutch3 participants
OverallUse of Walking Aids3C60 - 1 crutch5 participants
OverallUse of Walking AidsNMPK - 2 canes3 participants
OverallUse of Walking Aids3C60 - 2 canes3 participants
OverallUse of Walking AidsNMPK - 2 crutches9 participants
OverallUse of Walking Aids3C60 - 2 crutches8 participants
OverallUse of Walking AidsNMPK - Walking frame1 participants
OverallUse of Walking Aids3C60 - walking frame0 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026