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 Key findings:
-Significant new knowledge derived directly from patient and healthcare providers that have driven the technical development of this project and project portfolio
-Development and refinement of rapid design methodology based on identify (field-based research), develop & deliver (UK laboratories, field-based), test & transition (field-based)
-Increased research network to include organisations in Rwanda, Sri Lanka, Myanmar, Tanzania, South Africa
-Increased research capability through specialist staff allocation to this key project
This project's primary objective is the development of a low-cost prosthetic knee joint that met the unique and specific needs of persons with knee-disarticulation amputations in low- and middle-income countries. Early work in this project (2018-2019) saw the development of the technical specification for this prosthesis, and the delivery and patenting of an early design, which was trialed in the field in Cambodia. This period refined our group's identify, develop & deliver, test & transition methodology of product development, and resulted in a refining of the technical specification and a second iteration of the design (2019-2020). Direct engagement with persons with limb loss and clinical professionals ensured the continued development was in line with identified need and allowed the expansion of focus to include a paediatric version of the prosthesis - a population group that are particularly suited to the knee-disarticulation amputation type. As the project progressed, new partners and relationships were made with research institutions and patient groups in Tanzania, Sri Lanka, and Rwanda (2020-2021) that have enabled further projects to be identified that cater to the:
- needs of paediatric patients (a low-cost, high-activity foot that enables more energetic levels of play in children is now in development)
- clinical requirements of persons with limb loss in LMICs (prosthetic sockets that are easy to fit in remote areas, and are adjustable for changes in residual limb size)
- unique functional requirements of persons with knee-disarticulation or transfemoral amputations that live in undulous or mountainous areas of LMICs (another knee joint is now in development that enables easier terrain negotiation)
The ability to identify and develop prototypes for each of these areas of concern for persons with limb loss in LMICs has only been possible because of this funding stream, and each of these projects is currently either in receipt of its own funding to develop, test, and transition the technology to those that need it most, or in the process of application.
Our primary product, the low-cost knee joint (adult), has now reached technology readiness level (TRL) 6, and will reach TRL 7 by the end of the grant period (technology transfer, by end July 2021).
Additional funding secured in support of this research project has resulted in the installation of a rapid prototyping hub embedded within our group, and the employment of a specialist business development engineer to the group staff, who has a specific remit on the test & transition phase of our design cycle, further ensuring that the products that are developed to meet identified need, reach those that need them most.
Exploitation Route This funding award has enabled the development of a frugal technology pipeline for the development and delivery of new healthcare technologies for use in LMICs. Our wider research group are already applying this pipeline approach away from the prosthetic space, and is being used for the development and delivery on external fixation devices for healing bone fractures in Sri Lanka. The pipeline approach is key for engineers and designers, as it compels the consideration of environmental, economical, lifestyle, and cultural (EELC) requirements that are likely to be missed when considering design problems from the perspective of a nation with well-established healthcare systems. This approach has been put forward in symposiums consisting of members of the Exceed Research Network and the International Committee of the Red Cross and will be presented at the International Society of Prosthetists and Orthotists 2021 conference. Our design approach has always been with the consideration of the product end-user and LMIC partners, ensuring that capability for translation of both product and method can be achieved. This will be proven beyond the end of this funding award as we transition towards manufacture and distribution with our suite of developed products.
Sectors Healthcare

 
Description This research project comprises of four primary objectives, in priority order: 1. The development of a low-cost prosthesis that is suitable for use by through-knee amputees. 2. develop a pathway to support the translation of future frugal technology projects. 3. develop and populate a prosthetics and orthotics project pipeline. 4. to harness the frugal technologies pipeline in a reverse innovation approach. Over the three years of this funding programme, significant progress has been made in each of these objective areas. The priority objective, the development of a low-cost knee prosthesis that is suitable for use by knee-disarticulation amputees, has reached technology readiness level (TRL) 6 (pre-clinical evaluation) and will reach TRL 7 (technology transfer) by the end of this funding period. Achieving these high TRLs has followed our group's phased design methodology of 1. Identify. 2. Develop and Deliver. 3. Test and transition, whereby each phase has their own cyclical approach within the iterations of the cycle as a whole. Year 1 (2018-2019) of this project involved the first iteration of our design cycle, resulting in the delivery and patenting of a prototype which was subsequently tested in the field using clinicians and patients in Cambodia. Feedback from users and clinicians, as well as early business modelling in collaboration with the International Committee of the Red Cross (ICRC, one of the largest providers of low-cost prosthetics in the world), steered the second iteration of our design cycle in year 2 (2019-2020). This iteration improved the prosthesis ease of manufacture and ease of clinical fitting and alignment, as well as improving walking performance. This second iteration was supported by a successful grant application to fund a rapid prototyping suite to enhance Phase 2 of our design methodology. Increased networking focus in the second year of this project saw our customer requirements specification expand to include potential users in Tanzania and Sri Lanka, and additional funding was secured to ensure that those needs were identified and reflected in the technical specification of our product. The P&O pipeline was also finalised in Year 2, and identified customer requirements, particularly in the paediatric space, enabled progress to be made against objective 3 with the development of the technical requirements specification for paediatric knee prostheses. In year 3, the third iteration of the design methodology was implemented to further increase walking and standing performance specifications of the prosthetics knee joint, increase the cost-effectiveness of the device, and to enhance the capabilities of the knee joint for functionality with the knee-disarticulation amputation level. Increased networking in years 2 and 3 of this award has opened new partnerships with research institutions in Rwanda and South Africa, as well as with non-government organisations. These relationships have led to the identification of further prosthetic user requirements, and our group currently has a high-activity foot for both paediatric and adult patient groups, an adaptive knee joint to meet the requirements of rural, undulous terrain, and an adjustable, easy to fit prosthetic sock in the first design cycle at Phase 2 - Develop and Deliver; increasing the impact of this award across multiple patient groups in multiple countries where these technologies are most needed. The continued technical development of the prosthetic knee joint has expanded the suitability of the device from 2% of all lower limb amputees to 28%, and has seen the manufacture, assembly, and fitting of the device improved whilst maintaining adherence to the original aims and objectives of the funding award. The increased technical performance of the knee joints results in a large increase in the potential for significant societal impact when it is released to the market. The final stage of this award sees the transition towards manufacture and transition to scale readiness (TRL 7) achieved, competing the final, outstanding objectives of this award. The increase prosthetic programme developed by our group significantly reduces the impact of the barriers to healthcare access experienced by patient groups in LMICs through providing high-product functionality at low-cost, and reducing the clinical care burden through improved process efficiencies built into the design from the point of conception.
Sector Healthcare
Impact Types Societal,Economic

 
Description 'Improvement of prosthetic and orthotic healthcare services in Rwanda' - Internal Research England Global Challenges Research Fund
Amount £38,487 (GBP)
Organisation Imperial College London 
Sector Academic/University
Country United Kingdom
Start 08/2019 
End 12/2020
 
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 Low-cost knee disarticulation prosthetic device - Internal Imperial College EPSRC Impact Acceleration Award
Amount £79,473 (GBP)
Organisation Imperial College London 
Sector Academic/University
Country United Kingdom
Start 06/2019 
End 12/2020
 
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 UGHE 
Organisation University of Global Health Equity
Country Rwanda 
Sector Academic/University 
PI Contribution Co-organised a conference entitled "Transforming Amputation and Prosthetic Services Globally"
Collaborator Contribution Co-organised a conference entitled "Transforming Amputation and Prosthetic Services Globally"
Impact An online conference was delivered December 5th - 6th, with 407 registrations (53% male, 46% female) from 63 countries and 175 different organisations through the Zoom platform. This conference was supported by the development and delivery of a mini-documentary detailing amputee experience, needs, and requirements in both Rwanda and the UK, which has so far had over 8,000 views (6 Jan 2020) on YouTube. The partnership developed through the course of the delivery of this conference enables the continuation of our research programme into prosthetic development in low-resourced settings, with a specific view to the unique needs of amputees in Rwanda
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
 
Title Low-cost polycentric prosthetic knee joint 
Description The low-cost polycentric knee joint is a mechanical prosthetic knee that uses a unique polycentric mechanism and unique orientation of links to allow full flexion (sitting on heels) for kneeling and squatting for both above-knee (AK) and through-knee (TK) amputees. It has a best-in-class cosmetic appearance when flexed, and has a biphasic extension-assist profile, to support walking of varying speeds. It also transfers the patient's body weight through compression contact surface, greatly increasing the durability of the product - essential for distribution in low-resourced settings. 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Refinement. Clinical
Year Development Stage Completed 2020
Development Status Under active development/distribution
Impact Improved durability of product 
 
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