Low cost through knee prostheses. TaKeuP

Lead Research Organisation: Imperial College London
Department Name: Dept of Bioengineering

Abstract

Cambodia is one of the world's most landmine affected countries with over 64,000 casualties recorded since 1979 and over 25,000 amputees. Added to this there is also a rise in the number of amputations resulting from road traffic accidents. Currently around 10 million people in South East Asia, India and Sri Lanka need but do not have access to prosthetic and orthotic services and there is a deficit of circa 40,000 professionals. This project directly targets end-users (Prosthetists and amputees) in Cambodia with a view to future expansion into the Philippines, Myanmar, Indonesia and Sri Lanka through strategic partnership with Prosthetics and Orthotics NGO Exceed Worldwide and the Exceed Research Network. We have active collaborations with UK (and European) prosthetics manufacturers (Blatchfords, Otto Bock, Össur), NHS prosthetics and rehabilitation services, and the Defence National Rehabilitation Centre Headley Court.

Recent developments in medical care have resulted in a surgical preference for through-knee amputation where previously above knee amputation was considered preferable. Through-knee amputations allow the socket for the prosthesis to fit on the stump so that the load through the artificial foot and knee is transmitted directly to the end of the stump; this maintains healthy, normal load through the thigh bone. An above knee amputation does not permit this normal loading; the socket has to transmit the loads all the way to the pelvic bone, partially bypassing the thigh, causing pressure sores, inhibiting the range of motion of the amputated limb, and producing bone fragility in the thigh. Therefore, through-knee amputations result in a reduction in pain, fewer incidences of bone formation within muscle (a highly debilitating complication), the ability to bear significantly higher loads, and maintain bone health.

The cost (>£50,000 per device) and maintenance required make modern sockets and powered knee mechanisms designed for through-knee amputees inappropriate for use in low and middle income countries. Current low cost solutions for this provided by the adaptation of Red Cross knee joint prostheses suffer from major limitations such as an inability to be locked in extension, severe compromises on cosmetic appearance resulting in social exclusion, and a very low prosthetic knee joint (due to the long thigh component) producing other functional deficits.

In this project we will develop a low-cost through-knee prosthesis the initial concept for which has been developed by the applicants through prior work with partners in Cambodia. This will be developed further to create a pathway to support the translation of future frugal technology projects (projects that are low cost in terms of manufacture and maintenance) and we will populate this frugal technology pathway with a series of follow on prosthetics and orthotics projects for amputees. Finally, we will ensure that there is a route to harness the frugal technology development for low and middle income countries for the benefit of healthcare in the UK. This project will create a community of researchers, engineers and clinicians developing and translating affordable prostheses.

Planned Impact

The impact of this research would extend from new devices for amputees in low and middle income countries (LMICs) to economic impact in LMICs and beyond.

Society: TaKeuP will look to develop new applicable frugal devices in the field of prosthetics. It will benefit not only patients and their carers, but also healthcare providers (Prosthetists and Technicians) who currently have limited availability and resources to undertake the necessary adaptations to existing systems. Our innovation pathway will enable new concepts to be developed more quickly, driven by the needs and requirements of the end-user through a meaningful user engagement methodology. The concept for a new through-knee prosthesis, and the proposed pipeline projects of child-sized prosthesis and enriched physiological capacity will not only improve a user's functional ability but also prevent users from feeling conspicuous in social situations, an issue that is of prevalence in a society that can be inconsiderate towards people with disabilities.

Economy: The proposed devices will assist amputee victims of blast injuries and road traffic accidents in the process of returning to a functioning working life. As many of these users come from rural backgrounds this requires a robust prosthesis able to handle the demands of physical labour and prolonged squatting under load. The ability to return to a fully active workload affects not only the user but also those who are assigned as their carer, allowing two people to return to full time labour (or education).

The proposed innovation pathway has the utilisation of local manufacturers and maintenance facilities at its heart. As such, each new concept that passes through the pipeline will go towards increasing the demand for local manufacturing skills, boosting the local economic benefits even further as concepts roll-out to neighbouring countries.

The potential for Reverse Innovation could see the effects of these developments benefit not only the local economy within Cambodia, but also within the UK as the arising intellectual property will seed further investment in related research and the development of products through partners, licensees and spinouts. The creation and growth of companies will boost employment and enhance business revenue, license income and innovation in the UK knowledge economy, leading to wealth creation and economic prosperity. The UK is particularly well placed to exploit commercial opportunities arising from TaKeuP due to its strong research base, unified healthcare system, and world leading rehabilitation expertise as exemplified by Headley Court.

Knowledge: The development of an innovation pathway will help to translate technical knowledge from laboratories into the market place, while the network of collaborators will assist to empower researchers with knowledge from users and Prosthetists in the field as to the areas of primary interest, in order to focus their research. This network is critical to the flow of knowledge not only between the collaborators but also the knowledge which is disseminated to the community at large. The network provides a number of outlets through which knowledge gained within the developments associated with this project may be communicated.

People: The researchers in this project will develop multidisciplinary research skills in frugal healthcare technologies, complemented by professional skills, management and career development training delivered through Imperial's award winning postgraduate development centre, as well as bespoke training through courses within the Department of Bioengineering (e.g. Human Centred Design of Assistive and Rehabilitation Devices; Human Neuromechanical Control and Learning; Robotics). Personal and professional development will be enhanced through their three periods of research in Cambodia. TaKeuP will produce highly-skilled staff ready for careers in industry, healthcare and academia.
 
Description New knowledge has been generated on the needs and priorities of prosthetic and orthotic (P&O) patients in low-to-middle income countries (LMICs) as well as the process from identifying a P&O need to developing a solution and bringing it to the market. Through field work activities, we had the opportunity to collect quantitative data from P&O patients and healthcare professionals. As a result, we have refined the design specifications of our through-knee prosthesis and shifted our focus on the development of a paediatric version of our prototype. As a result, a new iteration of our prototype and a complete version of a pipeline leading from problem identification to the commercialisation of a P&O device in LMICs have been developed. Other P&O opportunities have also been identified that will lead to future grant applications.
A novel fitting and manufacturing process for our prototype has been co-developed with the P&O technicians in the Cambodian School of Prosthetics and Orthotics (CSPO). We have improved our understanding of how our prototype can be manufactured and fitted on an amputee.
Our research network has been expanded including more P&O clinics and schools in other LMICs, such as Sri Lanka, Thailand, Myanmar and Tanzania. Furthermore, we have developed a relationship with local manufacturers in Cambodia to map current manufacturing possibilities.
We have increased our research capacity by successfully applying for two internal grants to support this project. These grants allowed us to develop a 3D printing hub that can be used for the purposes of prototyping P&O devices, as well as explore the needs of P&O patients in other LMICs, such as Sub-Saharan African countries.
Exploitation Route New knowledge has been generated on the needs and priorities of prosthetic and orthotic (P&O) patients in low-to-middle income countries (LMICs) as well as the process from identifying a P&O need to developing a solution and bringing it to the market. Through field work activities, we had the opportunity to collect quantitative data from P&O patients and healthcare professionals. As a result, we have refined the design specifications of our through-knee prosthesis and shifted our focus on the development of a paediatric version of our prototype. As a result, a new iteration of our prototype and a complete version of a pipeline leading from problem identification to the commercialisation of a P&O device in LMICs have been developed. Other P&O opportunities have also been identified that will lead to future grant applications.
A novel fitting and manufacturing process for our prototype has been co-developed with the P&O technicians in the Cambodian School of Prosthetics and Orthotics (CSPO). We have improved our understanding of how our prototype can be manufactured and fitted on an amputee.



Our research network has been expanded including more P&O clinics and schools in other LMICs, such as Sri Lanka, Thailand, Myanmar and Tanzania. Furthermore, we have developed a relationship with local manufacturers in Cambodia to map current manufacturing possibilities.
We have increased our research capacity by successfully applying for two internal grants to support this project. These grants allowed us to develop a 3D printing hub that can be used for the purposes of prototyping P&O devices, as well as explore the needs of P&O patients in other LMICs, such as Sub-Saharan African countries.

We are now working with ICRC to take on our through knee joint prosthesis as an 'approved' prosthesis.
Sectors Healthcare

 
Description The research outcomes from this project within the last year have helped us achieve multiple objectives in all work packages of this project that regarded the development of a through-knee prosthesis, the development of a prosthetic and orthotic (P&O) pipeline, formation of a collaborative network, and engagement through outreach activities. These achievements helped us maximise the potential societal impact of P&O solutions developed by our research team and facilitate their implementation. By conducting a series of field work activities in Cambodia, Thailand, Sri Lanka, and Myanmar, we managed to develop a better understanding of the needs of P&O patients in low-to-middle income (LMICs) as well as landmine-affected countries. This helped us develop the newest design iteration of our prototype that is better suited to the needs of through-knee amputees in these settings. Due to our research findings, our focus has been shifted towards the development of a paediatric version of our through-knee prosthetic prototype, as this type of amputation is more popular to younger ages as it doesn't restrict growing of the bones. Finally, a manufacturing process has been streamlined for the latest iteration of our device, in collaboration with P&O technicians in the Cambodian School of Prosthetics and Orthotics (CSPO). All these findings helped us to reduce the risk of developing a prosthetic device that won't be adopted by the end-users and maximise the potential impact of delivering such a device to the Cambodian market. By visiting and researching other countries, apart from Cambodia, we have managed to update the design requirements of our device, make it relevant to the requirements of through knee amputees in other LMICs and widen its potential market uptake. More specifically, objectives 1.1 to 1.3 and 3.2 from Work Stream 1 and 3, respectively have been completed and this year focus will be on objectives 1.4 to 1.6 and 3.3. The P&O pipeline has been finalised. In order to gather more information on each aspect of the pipeline, we have established a wider collaborative network that consists of representatives/ stakeholders from all processes involved in the P&O healthcare market. We have established collaborations with more P&O clinics and training schools in various LMICs and other research institutions in the UK, while we have been in contact with manufacturing and services providing entities. With this network in place, the finalised pipeline can guide from problem identification to the commercialisation of a P&O solution to the market of LMICs. This pathway can now be exploited to prioritise and address the P&O needs, facilitate the implementation of a solution as well as maximise its impact. As part of this task, we have also organised and delivered a workshop in CSPO that familiarises front-line stuff to this process and establishes a common ground for the co-development of P&O solutions. This workshop was a knowledge exchange activity that also regarded the P&O teaching methods provided by the CSPO, with lecturers participating on all workshop activities. Objectives 2.1 to 2.2 and 3.1 from Work Stream 2 and 3, respectively, have been completed and this year focus will be on objectives 2.3 to 2.4.
 
Description A tool to assess the efficiency of low-cost lower limb prosthetic devices - imperial College internal research england gcrf
Amount £41,717 (GBP)
Funding ID A tool to assess the efficiency of low-cost lower limb prosthetic devices internal REsearch England GCRF 
Organisation Imperial College London 
Sector Academic/University
Country United Kingdom
Start 01/2020 
End 07/2020
 
Description Julia Higgins Award
Amount £3,197 (GBP)
Organisation Imperial College London 
Sector Academic/University
Country United Kingdom
Start 07/2018 
End 05/2019
 
Description • Research England GCRF Internal Funding
Amount £36,656 (GBP)
Organisation Imperial College London 
Sector Academic/University
Country United Kingdom
Start 10/2018 
End 09/2019
 
Description ICRC 
Organisation International Committee of the Red Cross
Country Switzerland 
Sector Charity/Non Profit 
PI Contribution jointly developing a through knee prosthesis for distribution by ICRC
Collaborator Contribution distribution and aiding in development.
Impact none yet.
Start Year 2020
 
Description • Royal College of Art 
Organisation Royal College of Art
Country United Kingdom 
Sector Academic/University 
PI Contribution o Organised a workshop for students in Royal College of Art to explore storytelling methods to engage exhibition audiences to prosthetic and orthotic challenges faced by people in landmine-affected countries.
Collaborator Contribution hosted workshop and provided delegates
Impact event organised
Start Year 2018
 
Description • University of Salford 
Organisation University of Salford
Department Salford Business School
Country United Kingdom 
Sector Academic/University 
PI Contribution o Part of original application o Conducted field work in April 2018 in collaboration with Imperial College. o Received the sensor they have developed and used it to gather preliminary results.
Collaborator Contribution Part of original application o Conducted field work in April 2018 in collaboration with Imperial College. o Received the sensor they have developed and used it to gather preliminary results.
Impact Part of original application o Conducted field work in April 2018 in collaboration with Imperial College. o Received the sensor they have developed and used it to gather preliminary results.
Start Year 2018
 
Description • University of Southampton 
Organisation University of Southampton
Department University of Southampton Clinical Trials Unit
Country United Kingdom 
Sector Academic/University 
PI Contribution o Conducted field work in April, November and December 2018 in collaboration with Imperial College. o Participated in a workshop organised by Imperial College London in November 2018 within the Cambodian School of Prosthetics and Orthotics.
Collaborator Contribution Conducted field work in April, November and December 2018 in collaboration with Imperial College. o Participated in a workshop organised by Imperial College London in November 2018 within the Cambodian School of Prosthetics and Orthotics.
Impact Conducted field work in April, November and December 2018 in collaboration with Imperial College. o Participated in a workshop organised by Imperial College London in November 2018 within the Cambodian School of Prosthetics and Orthotics.
Start Year 2018
 
Title PROSTHESIS FOR A THROUGH-KNEE AMPUTEE 
Description The present disclosure provides a prosthesis for a through-knee amputee.The prosthesis comprises a proximal limb portion and a distal limb portion. The proximal limb portion comprise a socket which is configured to receive the upper leg of a through-knee amputee.The prosthesis also comprises at least two hinges to connect the proximal limb portion to the distal limb portion so that they can rotate about a single axis of rotation. The prosthesis also comprises a contact member and an engagement element. One of the contact member and engagement element is attached the proximal limb portion and the other of the contact member and engagement element is attached to the distal limb portion. One of both of the contact member and engagement element are biased towards the other. The contact member is adapted so that when the proximal limb portion and the distal limb portion undergo extension from a position of flexion, the contact member contacts the engagement element to displace the engagement element and/or contact member against the bias. 
IP Reference WO2018224833 
Protection Patent granted
Year Protection Granted 2018
Licensed No
Impact Currently exploring exploitation
 
Description • Workshop entitled: 'Human-centred design, engineering and research methodologies on the development of prosthetic and orthotic solutions' 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact A 3-day workshop has been organised and delivered by Imperial College London, and hosted by the Cambodian School of Prosthetics and Orthotics in Phnom Penh, Cambodia, on 13-15/11/2018. Researchers from the University of Southampton were also invited and participated in the workshop. The participants were 20 2nd and 3rd year students, studying to become prosthetists and orthotists, 3 technicians, working in the limb fitting clinic, and 2 lecturers of the Cambodian School of Prosthetics and Orthotics. Through several activities, the participants were introduced into the design process and how it can be used to identify prosthetic and orthotic problems they are facing, develop solutions, and assess their outcome. The participants prioritised the needs they believe should be addressed first regarding the prosthetic and orthotic services provided currently in Cambodia, and proposed innovative solutions. All these are currently taken into consideration for future grants by Imperial College as well .
Year(s) Of Engagement Activity 2018
 
Description • Workshop entitled: 'To be another' 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact A 5-day workshop was organised between the Royal College of Arts and Imperial College London. In this, 20 students from the Royal College of Arts were challenged to construct narratives to connect an exhibition audience to a very real scenario: that of landmine victims and their care teams in Cambodia. A contemporary archive of raw media (photography, 360 images, film, interview transcripts), artefacts and first-hand accounts of field researchers were provided by the organisers to give them a window into this world. Participants were encouraged to use any digital or physical media of their choice, to explore new storytelling techniques. The aims were to explore the sense of empathy in an exhibition environment, the role of novel media in immersive storytelling and ethical considerations in storytelling. The outputs from the project were included in an exhibition proposal at Imperial College in 2019.
Year(s) Of Engagement Activity 2018