Amputation of Hip and Thigh, Level Unspecified
Conditions
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
3 months with 3C60 - 10 days wash out - 1 month with NMPK
1 month with NMPK - 3 months with 3C60
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Timed Get Up and Go (TGUG) | Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Locomotor Capabilities Index (LCI-5) | Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK | 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. |
| Use of Walking Aids | Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK | The 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 NMPK | 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. |
| SF-36v2™ Health Survey | Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK | 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. |
| Number of Falls | Measurement will be performed at 1 month with both devices | — |
Countries
Austria, France, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Group NMPK Then 3C60 | Group 3C60 Then NMPK |
|---|---|---|---|
| Additional disabilities forefoot amputation on the controlateral side | 2.9 Percentage of participants | 2.9 Percentage of participants | 0 Percentage of participants |
| Additional disabilities Handicap of the upper limbs | 5.7 Percentage of participants | 0 Percentage of participants | 11.1 Percentage of participants |
| Additional disabilities Hemiplegia after a stroke affecting balance | 2.9 Percentage of participants | 0 Percentage of participants | 5.6 Percentage of participants |
| Additional disabilities Trans-tibial amputation of the controlateral lower | 8.6 Percentage of participants | 2.9 Percentage of participants | 11.1 Percentage of participants |
| Additional disabilities Traumatism of the controlateral lower limb | 2.9 Percentage of participants | 2.9 Percentage of participants | 0 Percentage of participants |
| Age, Continuous | 65.06 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 participants | 17.6 Percentage of participants | 0 Percentage of participants |
| Amputation cause Traumatic | 22.9 Percentage of participants | 23.5 Percentage of participants | 22.2 Percentage of participants |
| Amputation cause Tumour | 11.4 Percentage of participants | 11.8 Percentage of participants | 11.1 Percentage of participants |
| Amputation cause Vascular | 45.7 Percentage of participants | 35.3 Percentage of participants | 55.6 Percentage of participants |
| Amputation cause Vascular diabetic | 11.4 Percentage of participants | 11.8 Percentage of participants | 11.1 Percentage of participants |
| Amputation level Knee disarticulation | 5.7 Percentage of participants | 5.9 Percentage of participants | 5.6 Percentage of participants |
| Amputation level Transfemoral | 94.3 Percentage of participants | 94.1 Percentage of participants | 94.4 Percentage of participants |
| Geographical area Rural | 31.4 Percentage of participants | 29.4 Percentage of participants | 33.3 Percentage of participants |
| Geographical area Urban | 68.6 Percentage of participants | 70.6 Percentage of participants | 66.7 Percentage of participants |
| Height | 171.3 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 participants | 5.9 Percentage of participants | 11.1 Percentage of participants |
| International Classification of Function (ICF) d4602 | 91.4 Percentage of participants | 94.1 Percentage of participants | 88.9 Percentage of participants |
| previous prosthesis Brake knee | 17.1 Percentage of participants | 17.6 Percentage of participants | 16.7 Percentage of participants |
| previous prosthesis Free knee | 5.7 Percentage of participants | 5.9 Percentage of participants | 5.6 Percentage of participants |
| previous prosthesis Hydraulic knee | 31.4 Percentage of participants | 29.4 Percentage of participants | 33.3 Percentage of participants |
| previous prosthesis Locked knee | 34.3 Percentage of participants | 29.4 Percentage of participants | 38.9 Percentage of participants |
| previous prosthesis Pneumatic knee | 11.4 Percentage of participants | 17.6 Percentage of participants | 5.6 Percentage of participants |
| prosthetic foot with mechanical knee Articulated | 17.1 Percentage of participants | 17.6 Percentage of participants | 16.7 Percentage of participants |
| prosthetic foot with mechanical knee Dynamic with carbon | 45.7 Percentage of participants | 41.2 Percentage of participants | 50.0 Percentage of participants |
| prosthetic foot with mechanical knee Dynamic without carbon | 25.7 Percentage of participants | 29.4 Percentage of participants | 22.2 Percentage of participants |
| prosthetic foot with mechanical knee Solid Ankle Cushion Heel (SACH) | 11.4 Percentage of participants | 11.8 Percentage of participants | 11.1 Percentage of participants |
| Sex/Gender, Customized Female | 22.9 Percentage of participants | 23.5 Percentage of participants | 22.2 Percentage of participants |
| Sex/Gender, Customized Male | 77.1 Percentage of participants | 76.5 Percentage of participants | 77.8 Percentage of participants |
| socket type For knee disarticulation | 5.7 Percentage of participants | 5.9 Percentage of participants | 5.6 Percentage of participants |
| socket type Quadrangular | 2.9 Percentage of participants | 0 Percentage of participants | 5.6 Percentage of participants |
| socket type With ischial containment | 88.6 Percentage of participants | 88.2 Percentage of participants | 88.9 Percentage of participants |
| Time since amputation | 61.4 months STANDARD_DEVIATION 85.5 | 51.3 months STANDARD_DEVIATION 62.1 | 70.8 months STANDARD_DEVIATION 105.1 |
| Weight | 76.1 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 participants | 76.5 Percentage of participants | 66.7 Percentage of participants |
| work status With a professional activity | 5.7 Percentage of participants | 0 Percentage of participants | 11.1 Percentage of participants |
| work status Without activity | 22.9 Percentage of participants | 23.5 Percentage of participants | 22.2 Percentage of participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 35 | 10 / 35 |
| serious Total, serious adverse events | 1 / 35 | 0 / 35 |
Outcome results
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall | Timed Get Up and Go (TGUG) | NMPK | 24.8 seconds | Standard Deviation 8.3 |
| Overall | Timed Get Up and Go (TGUG) | 3C60 | 21.6 seconds | Standard Deviation 9 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall | Locomotor Capabilities Index (LCI-5) | NMPK - Advances score | 18.5 Score between 0 and 56 | Standard Deviation 5.5 |
| Overall | Locomotor Capabilities Index (LCI-5) | 3C60 - Advanced score | 19.8 Score between 0 and 56 | Standard Deviation 5 |
| Overall | Locomotor Capabilities Index (LCI-5) | NMPK - Global score | 38.6 Score between 0 and 56 | Standard Deviation 9.5 |
| Overall | Locomotor Capabilities Index (LCI-5) | 3C60 - Global score | 41.7 Score between 0 and 56 | Standard Deviation 7.3 |
| Overall | Locomotor Capabilities Index (LCI-5) | NMPK - Basic score | 20.1 Score between 0 and 56 | Standard Deviation 4.8 |
| Overall | Locomotor Capabilities Index (LCI-5) | 3C60 - Basic score | 21.9 Score between 0 and 56 | Standard Deviation 3.8 |
Number of Falls
Time frame: Measurement will be performed at 1 month with both devices
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall | Number of Falls | 3C60 - number related to the knee | 0 falls |
| Overall | Number of Falls | NMPK - number of falls occured | 6 falls |
| Overall | Number of Falls | 3C60 - number of falls occured | 1 falls |
| Overall | Number of Falls | NMPK - number related to the knee | 4 falls |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall | 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 |
| Overall | 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 |
| Overall | 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 |
| Overall | 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 |
| Overall | 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 |
| Overall | 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 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall | SF-36v2™ Health Survey | NMPK - Physical Component Score | 43.1 scores on a scale | Standard Deviation 6.7 |
| Overall | SF-36v2™ Health Survey | 3C60 - Physical Component Score | 45.0 scores on a scale | Standard Deviation 8.4 |
| Overall | SF-36v2™ Health Survey | NMPK - Mental Component Score | 56.6 scores on a scale | Standard Deviation 9.7 |
| Overall | SF-36v2™ Health Survey | 3C60 - Mental Ccomponent Score | 56.0 scores on a scale | Standard Deviation 7.3 |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall | Use of Walking Aids | NMPK - none | 7 participants |
| Overall | Use of Walking Aids | 3C60 - none | 7 participants |
| Overall | Use of Walking Aids | NMPK - 1 cane | 7 participants |
| Overall | Use of Walking Aids | 3C60 - 1 cane | 7 participants |
| Overall | Use of Walking Aids | NMPK - 1 crutch | 3 participants |
| Overall | Use of Walking Aids | 3C60 - 1 crutch | 5 participants |
| Overall | Use of Walking Aids | NMPK - 2 canes | 3 participants |
| Overall | Use of Walking Aids | 3C60 - 2 canes | 3 participants |
| Overall | Use of Walking Aids | NMPK - 2 crutches | 9 participants |
| Overall | Use of Walking Aids | 3C60 - 2 crutches | 8 participants |
| Overall | Use of Walking Aids | NMPK - Walking frame | 1 participants |
| Overall | Use of Walking Aids | 3C60 - walking frame | 0 participants |