N/A
N=35
Assessment of Disability Compensation With the C-LEG COMPACT 2 Knee (Ref. 3C60 et 3C60=ST)
Amputation of Hip and Thigh, Level Unspecified
Bottom Line
View on ClinicalTrials.gov: NCT02382991 ↗Enrolled (actual)
35
Serious AEs
1.4%
Results posted
Oct 2019
Primary outcome: Primary: Timed Get Up and Go (TGUG) — 24.8; 21.6 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3C60-NMPK (Device); NMPK-3C60 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otto Bock France SNC
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Timed Get Up and Go (TGUG) |
24.8; 21.6 | — |
| SECONDARY Locomotor Capabilities Index (LCI-5) |
38.6; 41.7; 20.1; 21.9; 18.5; 19.8 | — |
| SECONDARY Use of Walking Aids |
7; 7; 7; 7; 3; 5 | — |
| SECONDARY QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version) |
3.7; 4.4; 4.1; 4.5; 3.7; 4.3 | — |
| SECONDARY SF-36v2™ Health Survey |
43.1; 45.0; 56.6; 56.0 | — |
| SECONDARY Number of Falls |
6; 1; 4; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02382991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.