MyLeg Osseointegrated Prosthesis

The MyLeg project develops osseointegrated leg prostheses that will allow amputees to walk more naturally, as the new leg will adapt to different walking patterns and be controlled by electrical impulses from the brain.

MyLeg: Smart and Intuitive Osseointegrated Transfemoral Prostheses Embodying Advanced Dynamic Behaviors.

Aetiology
Osseointegrated leg prosthesis
MyLeg Objectives
Impact
Participants
Publications

Funded under: H2020-EU.2.1.1. – INDUSTRIAL LEADERSHIP – Leadership in enabling and industrial technologies – Information and Communication Technologies (ICT)
Topic: ICT-25-2016-2017 – Advanced robot capabilities research and take-up
Project ID: 780871
From 2018-01-01 to 2021-12-31

Aetiology

Limb loss is one of the most physically and psychologically devastating events that can happen to a person. In USA, the main causes of lower-limb amputation are vascular diseases (70%), trauma (22%), congenital or birth defects (4%), and tumors (4%). Even if with appropriate rehabilitation many people can learn to walk or function again, amputation continues to be a large problem, as there still remains a significant gap between the most advanced prosthetic devices and their anatomical counterparts.
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Osseointegrated leg prosthesis

Osseointegration is based on the ability of human bone cells to attach to a metal surface. The term was first coined in 1952 by professor Per-Ingvar Branemark who also was the first to place a dental implant into a human patient in 1965. To date, osseointegration is also used for permanent anchorage of artificial limbs to the human skeleton. In a surgical procedure a metal (titanium) implant is inserted into the bone of the arm or leg and part of this implant penetrates through the skin. The artificial limb (prosthesis) is easily attached to this implant with a connector.

An osseointegrated prosthesis offers many advantages to individuals with an arm or leg amputation compared with a socket prosthesis (which fits over the stump of the amputated leg or arm). The attachment of the osseointegrated prosthesis is much more stable and provides a full range of joint movement, making walking much easier. An osseointegrated prosthesis does not cause pain or skin breakdown when used. Because the prosthesis is directly attached to the bone, the wearer feels as though their prosthesis is part of their own body by a process known as “natural osseoperception” (i.e. it feels as though it is their own leg or arm).

Osseointegration is a safe treatment, and inflammation of the bone is rare. A disadvantage is that the area where the implant enters the skin (called the “stoma”) has to be cleaned twice daily with soap and water. This is comparable with brushing the teeth. In some cases, the skin around the stoma may become irritated. In the first year after implantation, intense muscle pain may be felt. This muscle pain disappears as soon as the stump muscles become fitter and stronger.

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MyLeg Objectives

The MyLeg project aims to design a novel prosthetic system for amputees who have lost a leg from above the knee. This transfemoral prosthesis will be intuitively operated, sensed and trusted as a healthy and reliable counterpart for a variety of tasks.

The new prosthesis will combine three major features:

  • it will be fixed to the femoral bone via an osseointegrated implant. This enhances human-prosthesis interaction, perception and motion capabilities. Most current prostheses are connected to the stump via a socket, but the interface of stump and socket can cause discomfort.
  • it will be powered by a novel actuation system, which will include motors and springs. Depending on the walking pattern or terrain, our muscles can make our legs more compliant or stiffer. Variable stiffness actuators and novel composite materials will achieve energy efficiency, dependability, and adaptability to different tasks. This makes it possible to adapt to different walking patterns and terrains, and the prosthesis will have a degree of mechanical compliance just like a healthy leg.
  • it will have an intuitive control by electrical impulses from the brain. Myoelectric sensors are implanted in the stump muscles to interpret the amputee’s intention and to control the prosthesis.

The big step that the MyLeg project will take is to integrate these three main features, thanks to a multi-disciplinary team.
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Impact

Societal impact
Transfemoral amputees will better accept the prosthesis, their quality of life will improve, they will reach a higher degree of self-reliance, their social contacts will be enlarged, their (re-)integration in the society and in the labour-market will be facilitated.

Economic impact
Transfemoral amputees will need less support by formal/informal caregivers, which will reduce the burden on these groups and on society as a whole.

Global impact
MyLeg will impact the leadership role of Europe in the prosthetic market and, more in general, in the robotic world.
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Participants

The MyLeg project is a collaborative project between the University of Groningen, the University of Bologna, the Roessingh Research and Development, the company ÖSSUR, Twente University, Norwest Advanced Orthopaedics and the Radboudumc. The team includes roboticists, biomechanical and biomedical engineers, surgeons who are experts in osseointegration and implanting electromyographic sensors, physiotherapists and gait experts. Raffaella Carloni, robotics engineer at the University of Groningen, will lead the project.

University of Groningen (the Netherlands)
This team is based at the Robotics Group of the Faculty of Science and Engineering. The Robotics group develops systems that are intended to physically interact with uncertain dynamic environments and to cooperate with humans. The team’s main focus is the development of novel actuation systems, which are the key enabling components for motion generation. The work will be accomplished by developing unique mechanical designs and intelligent control architectures.
RUG
MyLeg Coordinator:
Ph.D. student:
Ph.D. student:
Ph.D. student:
Robotics Group
Raffaella Carloni
Vishal Raveendranathan
Aniket Mazumder
Anja E.M. Schmerbauch

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Radboud University Medical Center Nijmegen (the Netherlands)
This team is affiliated with the Orthopaedic Research Laboratory, which has expertise in the development, monitoring and statistical analysis of clinical studies. Furthermore, it is one of the world’s leading laboratories in osseointegration and failure analyses of orthopaedic hip and knee implants.
Since 2009, the Radboudumc has been offering osseointegrated prosthesis at their centre. Together with the departments of General Surgery and Rehabilitation Medicine, the Orthopaedic Research Laboratory will primarily focus on the measurements with patients: effects of osseointegration on surrounding muscles and bone; efficiency of various stages of mechatronic devices built-in the prosthesis.
Radboudumc
Principle Investigator:
Co-P.I.:
Co-P.I.:
Co-P.I.:
Ph.D. student:
Ph.D. student:
Ph.D. student:
Osseointegration
Nico Verdonschot
Jan Paul Frölke General Surgery
Henk van de Meent Rehabilitation Medicine
Vivian Weerdesteyn
Ruud Leijendekkers
Vera Kooiman
David Reetz

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University of Bologna (Italy)
This team is based at the Interdepartmental Centre for Industrial Research of Health Sciences & Technologies at the University of Bologna, which works in the field of advanced applications in mechanical engineering and materials technology.
UniBo
Principle Investigator:
Co-P.I.:
Co-P.I.:
PostDoc:
Ph.D. student:
Research Group on Electrospinning (RGE)
Andrea Zucchelli
Maria Letizia Focarete
Davide Fabiani
Tommaso Maria Brugo
Johnnidel Tabucol

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University of Twente (the Netherlands)
This team is affiliated with the Biomechanical Engineering group. Their research focuses on the interaction between the human motor system and medical devices that support this system. The result of this research is applied in the development of innovative devices.
TU
Principle Investigator:
Co-P.I.:
Department of Biomedical Engineering (BE)
Bart Koopman
Edsko E.G. Hekman

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The Roessingh Research and Development (The Netherlands)
RRD is a research and development SME in the area of rehabilitation technology and telemedicine with strong formalized links to the Roessingh Rehabilitation Center. The mission of Roessingh Research and Development is to carry out scientific research and contribute to its valorization and implementation in clinical practice, by close cooperation with clinical centers and industry.
RRD
Principle Investigator:
Co-P.I.:
Co-P.I.:
Ph.D. student:
Roessingh Research and Development
Hermie Hermens
Jaap Buurke
Erik Prinsen
Eline van Staveren

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ÖSSUR (Iceland)
This company was founded by Össur Kristinsson, a prosthetist and an amputee. The company originally started life as a prosthetic clinic in 1971, steadily building a world-class reputation for the design and production of prosthetic liners, sockets and locking systems. More than 130 people at ÖSSUR are currently working on R&D in Iceland, France and the USA. ÖSSUR‘s head office is in Iceland.
The company operates a strict and effective quality control system meeting all ISO 13485 requirements and has recently incorporated an EMS system according to ISO 14001. ÖSSUR participates in the work of ISO TC 168 on creating testing standards for prosthetics.
ÖSSUR
Principle Investigator:
Co-P.I.:
Co-P.I.:
Co-P.I.:
Co-P.I.:
ÖSSUR U.K.
Freygardur Thorsteinsson
Thor Fridriksson
Gudrun Erla Olafsdotttir
Magnus Ragnar Gudmundsson
Magnús Oddsson

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Norwest Advanced Orthopaedics (Australia)
This private orthopaedic clinic is based in Sydney. Professor Munjed Al Muderis and specialists from the Osseointegration Group of Australia provide above and below knee amputees with a leg replacement that uses an OPL implant, which is designed to be as close to the human anatomy as possible.
N.A.O.
Principle Investigator:
Co-P.I.:
Norwest Advanced Orthopaedics
Munjed Al Muderis
William Lu

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Publications

No publications yet.
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