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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00754-43 | Registry Identifier | RCB (ANSM) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMPK-3C60 | Other | D0 + 30 days: evaluation with the non-microprocessor knee. D1 + 90 days: evaluation with the 3C60 knee. |
|
| 3C60-NMPK | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3C60-NMPK | Device | 3 months with 3C60 - 10 days wash out - 1 month with NMPK |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Chiesa, Physician | Institut Robert Merle d'Aubigné - 2 rue du Parc 94460 Valenton - France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonderkrankenanstalt Zicksee | Sankt Andrä am Zicksee | 7161 | Austria | |||
| CRMPR "Les Herbiers" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10414769 | Background | Schoppen T, Boonstra A, Groothoff JW, de Vries J, Goeken LN, Eisma WH. The Timed "up and go" test: reliability and validity in persons with unilateral lower limb amputation. Arch Phys Med Rehabil. 1999 Jul;80(7):825-8. doi: 10.1016/s0003-9993(99)90234-4. | |
| 17207685 | Background | Dite W, Connor HJ, Curtis HC. Clinical identification of multiple fall risk early after unilateral transtibial amputation. Arch Phys Med Rehabil. 2007 Jan;88(1):109-14. doi: 10.1016/j.apmr.2006.10.015. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 3C60 (90 Days), Washout (10 Days), NMPK (30 Days) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| NMPK-3C60 | Device | 1 month with NMPK - 3 months with 3C60 |
|
|
| Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK |
| Use of Walking Aids | The type of walking aids used with each device will be recorded. | Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK |
| 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. | Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK |
| 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. | Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK |
| Number of Falls | Measurement will be performed at 1 month with both devices |
| Bois-Guillaume |
| 76230 |
| France |
| Hôpital d'instruction des Armées Percy | Clamart | 92141 | France |
| Centre Hospitalier de Cornouaille Concarneau | Concarneau | 29900 | France |
| Centre de réadaptation de Coubert | Coubert | 77170 | France |
| CHU de Grenoble Hôpital Sud | Échirolles | 38434 | France |
| Clinique Chantecler | Marseille | 13012 | France |
| Institut Régional de Médecine Physique et de Réadaptation | Nancy | 54042 | France |
| Institut National des Invalides | Paris | 75007 | France |
| Hôpital Léopold Belan | Paris | 75010 | France |
| Pôle Saint-Hélier | Rennes | 35043 | France |
| Hôpital privé de l'Est Lyonnais | Saint-Priest | 69794 | France |
| Centre l'Adapt Thionis | Thionville | 57100 | France |
| Institut Robert Merle d'Aubigné | Valenton | 94460 | France |
| Universitätsmedizin Göttingen | Göttingen | 37075 | Germany |
| 15129398 | Background | Franchignoni F, Orlandini D, Ferriero G, Moscato TA. Reliability, validity, and responsiveness of the locomotor capabilities index in adults with lower-limb amputation undergoing prosthetic training. Arch Phys Med Rehabil. 2004 May;85(5):743-8. doi: 10.1016/j.apmr.2003.06.010. |
| 10378500 | Background | Gauthier-Gagnon C, Grise MC, Potvin D. Enabling factors related to prosthetic use by people with transtibial and transfemoral amputation. Arch Phys Med Rehabil. 1999 Jun;80(6):706-13. doi: 10.1016/s0003-9993(99)90177-6. |
| 22223685 | Background | Burnfield JM, Eberly VJ, Gronely JK, Perry J, Yule WJ, Mulroy SJ. Impact of stance phase microprocessor-controlled knee prosthesis on ramp negotiation and community walking function in K2 level transfemoral amputees. Prosthet Orthot Int. 2012 Mar;36(1):95-104. doi: 10.1177/0309364611431611. Epub 2012 Jan 5. |
| Background | Gauthier-Gagnon, C, grisé, MCL, Lepage Y. The Locomotor Capabilities Index : Content validity. J rehabil OutcomesMeas 2(4) : 40-46, 1998. |
| 7993169 | Background | Gauthier-Gagnon C, Grise MC. Prosthetic profile of the amputee questionnaire: validity and reliability. Arch Phys Med Rehabil. 1994 Dec;75(12):1309-14. |
| 8347072 | Background | Grise MC, Gauthier-Gagnon C, Martineau GG. Prosthetic profile of people with lower extremity amputation: conception and design of a follow-up questionnaire. Arch Phys Med Rehabil. 1993 Aug;74(8):862-70. doi: 10.1016/0003-9993(93)90014-2. |
| 10159726 | Background | Demers L, Weiss-Lambrou R, Ska B. Development of the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST). Assist Technol. 1996;8(1):3-13. doi: 10.1080/10400435.1996.10132268. |
| 7667543 | Background | Leplege A, Mesbah M, Marquis P. [Preliminary analysis of the psychometric properties of the French version of an international questionnaire measuring the quality of life: the MOS SF-36 (version 1.1)]. Rev Epidemiol Sante Publique. 1995;43(4):371-9. French. |
| Background | Leplège, A. (2001). Introduction, enjeux, définitions. In J. Coste et A. Leplège (Eds.), Mesure de la santé perceptuelle et de la qualité de vie : méthodes et applications (pp 15-36). Paris : Editions Estem |
| Background | Ware JE, Snow KK, Kosinski M, Gandek B (1993). Health survey : manual and interpretation guide. Boston, Massachussets : The Health Institute, New England Medical Center, 1993 |
| 1593914 | Background | Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. |
| 15932782 | Background | Loiret I, Paysant J, Martinet N, Andre JM. [Evaluation of amputees]. Ann Readapt Med Phys. 2005 Jul;48(6):307-16. doi: 10.1016/j.annrmp.2005.03.009. Epub 2005 Apr 15. French. |
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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The Age of the participants was recorded at baseline. This was meant for describing the population. No value was considered better or worse outcome. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex/Gender, Customized | The sexe of the participants was recorded at baseline. This was meant for describing the population. No value was considered better or worse outcome. | Number | Percentage of participants |
| |||||||||||||||
| Amputation cause | Amputation cause was recorded at baseline. This was meant for describing the population. No amputation cause was considered better or worse outcome. | Number | Percentage of participants |
| |||||||||||||||
| Amputation level | Amputation level was recorded at baseline. This was meant for describing the population. No amputation level was considered better or worse outcome. | Number | Percentage of participants |
| |||||||||||||||
| Weight | Participants' weight was recorded at Baseline. This was meant for describing the population. No value was considered better or worse outcome. | Mean | Standard Deviation | Kg |
| ||||||||||||||
| Height | Height of the participants was recorded at baseline. This was meant for describing the population. No value was considered better or worse outcome. | Mean | Standard Deviation | cm |
| ||||||||||||||
| Time since amputation | Time since amputation was recorded at baseline. This was meant for describing the population. No value was considered better or worse outcome. | Mean | Standard Deviation | months |
| ||||||||||||||
| International Classification of Function (ICF) | International Classification of Functioning was recorded at baseline. This was meant for describing the population. No mobility grade was considered better or worse outcome. d4602: Moving around outside the home and other buildings d4601: Moving around within buildings other than home | Number | Percentage of participants |
| |||||||||||||||
| Additional disabilities | Additional disabilities were recorded at baseline. This was meant for describing the population. No data was considered better or worse outcome. | Number | Percentage of participants |
| |||||||||||||||
| Geographical area | Geographical area was recorded at baseline. This was meant for describing the population. No data was considered better or worse outcome. | Number | Percentage of participants |
| |||||||||||||||
| work status | Work status was recorded at baseline. This was meant for describing the population. No data was considered better or worse outcome. | Number | Percentage of participants |
| |||||||||||||||
| previous prosthesis | Type of knee on the previous prosthesis was recorded at baseline. This was meant for describing the population. No data was considered better or worse outcome. | Number | Percentage of participants |
| |||||||||||||||
| socket type | Socket type was recorded at baseline. This was meant for describing the population. No data was considered better or worse outcome. | Number | Percentage of participants |
| |||||||||||||||
| prosthetic foot with mechanical knee | Prosthetic foot on the previous prosthesis was recorded at baseline. This was meant for describing the population. No foot type was considered better or worse outcome. | Number | Percentage of participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | seconds | Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK |
|
|
| |||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | Score between 0 and 56 | Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Use of Walking Aids | The type of walking aids used with each device will be recorded. | No significant difference in the repartition of walking aids was - a priori- expected between both devices: NMPK and 3C60. | Posted | Number | participants | Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK |
|
|
| |||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | Score from 0 to 5 | Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK |
|
| ||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | scores on a scale | Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Falls | Posted | Number | falls | Measurement will be performed at 1 month with both devices |
|
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NMPK | Participants with non microprocessor-controlled knee joint | 1 | 35 | 2 | 35 | ||
| EG001 | 3C60 | Participants with 3C60 knee joint | 0 | 35 | 10 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization due to other reason than amputation | Surgical and medical procedures |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non serious adverse events related to the knee | Social circumstances |
| |||
| Non serious adverse events maybe related to the knee | Social circumstances |
| |||
| Non serious adverse events not related to the knee | Social circumstances |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aurélie LACROIX | OTTOBOCK FRANCE | 0033 (0)7 86 29 52 03 | market.access@ottobock.fr |
| Female |
|
| Vascular diabetic |
|
| Traumatic |
|
| Tumour |
|
| Infectious |
|
| Knee disarticulation |
|
| d4601 |
|
| forefoot amputation on the controlateral side |
|
| Handicap of the upper limbs |
|
| Traumatism of the controlateral lower limb |
|
| Hemiplegia after a stroke affecting balance |
|
| Rural |
|
| Without activity |
|
| Retired |
|
| Brake knee |
|
| Pneumatic knee |
|
| Hydraulic knee |
|
| Free knee |
|
| With ischial containment |
|
| For knee disarticulation |
|
| Dynamic without carbon |
|
| Articulated |
|
| Solid Ankle Cushion Heel (SACH) |
|
|
| Denominators |
|---|
| Categories |
|---|
| NMPK - none |
| |||||
| 3C60 - none |
| |||||
| NMPK - 1 cane |
| |||||
| 3C60 - 1 cane |
| |||||
| NMPK - 1 crutch |
| |||||
| 3C60 - 1 crutch |
| |||||
| NMPK - 2 canes |
| |||||
| 3C60 - 2 canes |
| |||||
| NMPK - 2 crutches |
| |||||
| 3C60 - 2 crutches |
| |||||
| NMPK - Walking frame |
| |||||
| 3C60 - walking frame |
|
|
|
| Title | Measurements |
|---|---|
|
| 3C60 - number of falls occured |
|
| NMPK - number related to the knee |
|
| 3C60 - number related to the knee |
|