NCT02382991

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
3 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
4 years until next milestone

Results Posted

Study results publicly available

October 23, 2019

Completed
Last Updated

October 23, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

February 25, 2015

Results QC Date

December 28, 2018

Last Update Submit

September 30, 2019

Conditions

Amputation of Hip and Thigh, Level Unspecified

Keywords

Moderately active amputeesC-leg CompactKnee prosthesisKenevoMicroprocessor controlled kneeAmputation3C60Timed Get Up and Go (TGUG)Locomotors Capacities Index (LCI)QUESTShort Form survey (SF-36)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Locomotor Capabilities Index (LCI-5)

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

  • Use of Walking Aids

    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)

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

  • SF-36v2™ Health Survey

    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

Study Arms (2)

NMPK-3C60

OTHER

D0 + 30 days: evaluation with the non-microprocessor knee. D1 + 90 days: evaluation with the 3C60 knee.

Device: 3C60-NMPK

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.

Device: NMPK-3C60

Interventions

3C60-NMPKDEVICE

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

Also known as: Mechanical knee joint
NMPK-3C60
NMPK-3C60DEVICE

1 month with NMPK - 3 months with 3C60

Also known as: C-LEG COMPACT 2, KENEVO
3C60-NMPK

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Sonderkrankenanstalt Zicksee

Sankt Andrä am Zicksee, 7161, Austria

Location

CRMPR "Les Herbiers"

Bois-Guillaume, 76230, France

Location

Hôpital d'instruction des Armées Percy

Clamart, 92141, France

Location

Centre Hospitalier de Cornouaille Concarneau

Concarneau, 29900, France

Location

Centre de réadaptation de Coubert

Coubert, 77170, France

Location

CHU de Grenoble Hôpital Sud

Échirolles, 38434, France

Location

Clinique Chantecler

Marseille, 13012, France

Location

Institut Régional de Médecine Physique et de Réadaptation

Nancy, 54042, France

Location

Institut National des Invalides

Paris, 75007, France

Location

Hôpital Léopold Belan

Paris, 75010, France

Location

Pôle Saint-Hélier

Rennes, 35043, France

Location

Hôpital privé de l'Est Lyonnais

Saint-Priest, 69794, France

Location

Centre l'Adapt Thionis

Thionville, 57100, France

Location

Institut Robert Merle d'Aubigné

Valenton, 94460, France

Location

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

Location

Related Publications (15)

  • 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.

    PMID: 10414769BACKGROUND

  • 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.

    PMID: 17207685BACKGROUND

  • 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.

    PMID: 15129398BACKGROUND

  • 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.

    PMID: 10378500BACKGROUND

  • 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.

    PMID: 22223685BACKGROUND

  • Gauthier-Gagnon, C, grisé, MCL, Lepage Y. The Locomotor Capabilities Index : Content validity. J rehabil OutcomesMeas 2(4) : 40-46, 1998.

    BACKGROUND

  • Gauthier-Gagnon, C, Grisé, MCL, Potvin, L. Predisposing factors related to prosthetic use by people with a transtibial and transfemoral amputation. J Prosthet Orthot 10: 99-109, 1998

    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.

    PMID: 7993169BACKGROUND

  • 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.

    PMID: 8347072BACKGROUND

  • 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.

    PMID: 10159726BACKGROUND

  • 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.

    PMID: 7667543BACKGROUND

  • 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

    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.

    PMID: 1593914BACKGROUND

  • 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.

    PMID: 15932782BACKGROUND

Results Point of Contact

Title
Aurélie LACROIX
Organization
OTTOBOCK FRANCE
market.access@ottobock.fr
0033 (0)7 86 29 52 03

Study Officials

  • Gerard Chiesa, Physician

    Institut Robert Merle d'Aubigné - 2 rue du Parc 94460 Valenton - France

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 9, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

October 23, 2019

Results First Posted

October 23, 2019

Record last verified: 2019-09

Locations

AU(1)FR(13)DE(1)