Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04700085 |
| Other study ID # |
837_ReMotion_Knee |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 27, 2019 |
| Est. completion date |
August 7, 2019 |
Study information
| Verified date |
January 2021 |
| Source |
Sint Maartenskliniek |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Ambulatory mobility and function are important aspects in the quality of life of people with
lower limb amputations and prostheses. Regaining mobility is often challenging, especially
for patients with transfemoral, or above-knee, amputations. In the past decades, new types of
knee prosthetics have entered the market. The standard care in Europe and the US at this
moment is the mechanical, or non-microprocessor controlled, knee (NMPK). While the production
costs of these NMPK's are lower than those of the MPK's (microprocessor controlled knee),
consumer prices still reach up to $5000. Recently, the ReMotion Knee ($80) was developed as a
new and affordable alternative to the currently available mechanical knees. The ReMotion Knee
is mostly used in low-income countries, but has now been approved according to the ISO 10328
standards and has received the CE Mark. This knee could be a more affordable alternative for
the prosthetic knees used in high-income countries, thereby decreasing health related costs
within the amputation population. However, research on patient's functional abilities and
personal experiences with the knee is very limited and has not been investigated within more
developed countries. Therefore, the objective of this study is to compare the ReMotion Knee
and the current prosthetic knee of patients with a transfemoral amputation or
knee-exarticulation in terms of functional mobility, balance, and experienced walking
comfort, balance trust, fatigue and performance of the knee. it is expected that the ReMotion
Knee will perform slightly worse than the participants' current prosthetic knees.
Description:
The primary aim of healthcare organizations is to optimize the quality of life of their
patients while keeping a good balance between quality and costs. More advanced medical
technologies are constantly being developed to improve quality of life. However, these
technologies also lead to rising healthcare costs in high-income countries. Cost pressures
from medical innovations, along with the ageing population form a substantial threat to the
long-term sustainability of healthcare systems in high-income countries. Reverse innovations
(products or ideas originally designed for use in low-income countries that are 'upgraded'
and implemented in high-income countries) provide an opportunity to restrain the rising
healthcare costs in high-income countries. These products are often low-priced, easy to use,
and designed to function and survive in extreme and unpredictable conditions. However,
low-income country of origin products are still generally perceived as less reliable and safe
and they are rarely researched as an alternative to the current standard of care within the
medical sector.
The field of lower limb prosthetics is a typical example of a medical field with unceasing
technological developments, accompanied by rising expenses. With the rising incidence of
lower-limb amputations and the rising prosthetic prices, the costs of prosthetics care will
keep increasing. Reverse innovation could play an essential role in controlling the costs of
prosthetic care in the upcoming decades. However, research on new, lower-priced alternative
prostheses for use in high-income countries is very scarce and deserves more attention. An
example of a potential reverse innovation for the prosthetics market is the ReMotion knee: an
$80 mechanical knee recently designed by D-Rev (San Francisco, CA, USA) for use in low-income
countries. The ReMotion Knee has a polycentric design and a lifespan of about 3-5 years,
comparable to other mechanical knees, but does not include a pneumatic or hydraulic system.
It is easy to use, provides patients with a basic functional mobility, and is low priced,
especially compared to the standard care mechanical knees ranging between $1000 and $4000 in
the Netherlands. The ReMotion Knee could in this new way propose an opportunity to greatly
reduce healthcare costs among amputees in high-income countries. So far there is no research
available on health outcomes with the ReMotion Knee other than overall user satisfaction, and
it has never been evaluated as an alternative prosthetic knee for use in high-income
countries.
This study aims to evaluate the ReMotion Knee as a potential reverse innovation and provide
insight in the value of reverse innovation. To this end, the ReMotion Knee was compared with
currently used and comparable mechanical prosthetics knees in high-income countries. The
knees were evaluated based on the most important health outcomes for people with a lower-limb
amputation: functional mobility, walking comfort, balance and trust in balance. Furthermore,
experienced fatigue and performance with the knees were examined. As the ReMotion Knee has
less features advanced features than most polycentric prosthetic knees currently used, it was
expected that all would be slightly lower with the ReMotion Knee.
