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Lower Limb Amputation Above Knee (Injury)NCT04700085

Reverse Innovation in Western Health Care: the ReMotion Prosthetic Knee.

A study testing ReMotion Knee in people with Lower Limb Amputation Above Knee (Injury) and Lower Limb Amputation Knee, run by Sint Maartenskliniek at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ReMotion Knee
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteNetherlands
Study dates
27 Feb 2019to 7 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Medicare Functional Classification Level (MFCL) 2 or 3 (most probable users of the ReMotion Knee)
  • at least one year since amputation
  • currently using a polycentric mechanical prosthetic knee.

Who cannot join

  • stump pain that increases with activity
  • a hip flexion contracture > 20 degrees
  • inability to stand and walk for thirty minutes
  • weight >80kg (weight limit of the ReMotion Knee)
  • a prosthetic socket connection that did not fit the ReMotion Knee
  • an osseointegrated prosthesis

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Sint Maartenskliniek

    Ubbergen, Gelderland, 6574NA

Other trials in Netherlands

About this study

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.

Read the detailed 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.

Being tested
ReMotion Knee
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReMotion KneeDevice

    The ReMotion Knee is a prosthetic knee mostly used in low-income countries. It has been approved according to the ISO 10328 standards and has received the CE Mark.

Study groups in NCT04700085
Study groupRoleWhat they receive
ReMotion KneeExperimentalThe ReMotion Knee (mechanical prosthetic knee type) was used during measurements
Receives: Device: ReMotion Knee
Current prosthetic kneeNo interventionThe participant's current prosthetic knee was used during measurements

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. L-test

    Measure for functional mobility

    Measured: 5 minutes

Secondary outcomes (8)
  1. Four Square Step Test (FSST)

    Measure for presicion stepping

    Measured: 5 minutes

  2. Berg Balance Scale (BBS)

    Measure for static balance

    Measured: 15 minutes

  3. Weight distribution during static stance

    Measure for static balance

    Measured: 2 minutes

  4. Modified Emory Functional Amputation Profile (mEFAP)

    Measure for functional mobility

    Measured: 5 minutes

  5. Experienced walking comfort

    Experienced walking comfort is measured with a visual analog scale (VAS) of 10 centimeters (lowest score is 0, highest score is 10).

    Measured: On average, after 30 minutes and after 90 minutes

  6. Experienced trust in balance

    Experienced trust in balance is measured with a visual analog scale (VAS) of 10 centimeters (lowest score is 0, highest score is 10).

    Measured: On average, after 30 minutes and after 90 minutes

  7. Experienced performance of the knee

    Experienced performance of the knee is measured with a visual analog scale (VAS) of 10 centimeters (lowest score is 0, highest score is 10).

    Measured: On average, after 30 minutes and after 90 minutes

  8. Experienced fatigue

    Experienced fatigue is measured with a visual analog scale (VAS) of 10 centimeters (lowest score is 0, highest score is 10).

    Measured: On average, after 30 minutes and after 90 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2021
  2. Study start27 Feb 2019
  3. Primary completion7 Aug 2019
  4. Study completion7 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized crossover trial design
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04700085
Sponsor's protocol ID
837_ReMotion_Knee
Status last verified
Jan 2021
First submitted
6 Jan 2021
Last updated
7 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ReMotion Knee in people with Lower Limb Amputation Above Knee (Injury) and Lower Limb Amputation Knee, run by Sint Maartenskliniek at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

L-test (time frame: 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.

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