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.
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
- Conditions the study is for
- Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
- 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.
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 group | Role | What they receive |
|---|---|---|
| ReMotion Knee | Experimental | The ReMotion Knee (mechanical prosthetic knee type) was used during measurements Receives: Device: ReMotion Knee |
| Current prosthetic knee | No intervention | The 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.
L-test
Measure for functional mobility
Measured: 5 minutes
Secondary outcomes (8)
Four Square Step Test (FSST)
Measure for presicion stepping
Measured: 5 minutes
Berg Balance Scale (BBS)
Measure for static balance
Measured: 15 minutes
Weight distribution during static stance
Measure for static balance
Measured: 2 minutes
Modified Emory Functional Amputation Profile (mEFAP)
Measure for functional mobility
Measured: 5 minutes
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
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
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
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.
- First posted7 Jan 2021
- Study start27 Feb 2019
- Primary completion7 Aug 2019
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Above Knee (Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noël LW Keijsers, PhD, Study chair, Sint Maartenskliniek
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse Innovation in Western Health Care: the ReMotion Prosthetic Knee.
- ClinicalTrials.gov ID
- NCT04700085
- Acronym / sponsor ID
- 837_ReMotion_Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover trial design
| Arm | Type | Receives |
|---|---|---|
| ReMotion Knee | Experimental | Device: ReMotion KneeThe ReMotion Knee (mechanical prosthetic knee type) was used during measurements |
| Current prosthetic knee | No intervention | –The participant's current prosthetic knee was used during measurements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReMotion KneeThe 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. | Device | ReMotion Knee |
Primary outcome
L-test
Time frame: 5 minutes
Measure for functional mobility
8 secondary outcomes
Four Square Step Test (FSST)
Time frame: 5 minutes
Berg Balance Scale (BBS)
Time frame: 15 minutes
Weight distribution during static stance
Time frame: 2 minutes
Modified Emory Functional Amputation Profile (mEFAP)
Time frame: 5 minutes
Experienced walking comfort
Time frame: On average, after 30 minutes and after 90 minutes
Experienced trust in balance
Time frame: On average, after 30 minutes and after 90 minutes
Experienced performance of the knee
Time frame: On average, after 30 minutes and after 90 minutes
Experienced fatigue
Time frame: On average, after 30 minutes and after 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noël LW Keijsers, PhD study chair
Sint Maartenskliniek
1 site in 1 country: see every site and its status.
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.