Intervention for early stage osteoarthritis or cartilage injury

Lead Research Organisation: Imperial College London
Department Name: Dept of Mechanical Engineering

Abstract

Orthopaedic surgeons treat a wide variety of patients with cartilage damage, from young athletes with cartilage injury to elderly patients with advanced osteoarthritis. There are a variety of treatment options, and these are chosen based on the age of the patient. For patients under the age of 35, biological repair is successful. Biological repair includes techniques that try and make the cartilage heal itself by stimulating regenerative cells from the underlying bone (microfracture) or removing healthy cartilage cells from a non load bearing part of the joint, growing them in the laboratory, and re-implanting in the defect. For older patients, total or partial joint replacement is more reliable. The average age of total hip and knee replacement patients in the UK is 69 and 70 years respectively, and these have remained constant over the past five years indicating no trend for surgeons to replace joints of younger patients. There is therefore a wide gap in the treatments available for patients in the 35 to 60 year age bracket who are considered too old for biological repair, but too young to be considered ideal candidates for joint replacement. The aim of the fellowship is to develop the technology for patients in this age group that can replace the cartilage surface without removing bone stock such that any future partial or total joint replacements can be performed as a normal index procedure.

To achieve this aim, the fellowship will use advanced materials and manufacturing techniques to create the technology required for cartilage substitution implants with ultra low friction and wear properties that will protect the device from the service loads it will experience in use. In addition to providing the orthopaedic surgeon with a treatment option for the 35-60 year old patient, developing this technology will have application across the whole orthopaedic field. It will generate the mechanical boundary conditions and test methods for further development of biological repair scaffolds and repair material (currently mostly fibrocartilage rather than the desired hyaline cartilage) for patients under 35 years old. The development of polymer technology will provide the information required for low cost all polymer implants that would be suitable for less functionally demanding patients. The manufacturing methods may also be suitable for interpositional implants with tailored frictional properties and morphology to prevent dislocation. Each of these themes will be pursued within the fellowship.

Planned Impact

There are few options available to the orthopaedic surgeon to treat cartilage damage or disease in patients who are in the 35 to 60 year age bracket. Biological repair is most successful in patients under the age of 35 years, and the average age of hip and knee replacement is 69 and 70 years respectively. The proposed fellowship will provide new options to the orthopaedic surgeon in the management of chondral defects or early osteoarthritis by developing several different technologies that will lead to a new interventional stage after a failed biological repair, but without compromising later partial or total joint replacement. These new options will be perfect for patients in the 35-60 year age bracket who are usually in full time employment and have families, such that restoration of their active lifestyles is beneficial to society and the economy.

By providing new early interventional options, the technology developed during the fellowship will help the current generation of total joint replacements become the salvage procedure. This is particularly beneficial for knee replacement patients where kinematics are clearly not being restored - over 40% find a simple task like kneeling down and standing back up again either 'extremely difficult' or 'impossible' (study of 16,000 patients, New Zealand Joint Registry 2010). This represents a contribution to the health of the nation with societal and economical benefits as mentioned above.

The fellowship also develops different additive manufacturing processes including laser melting and customised injection moulding. Additive manufacture is likely to become a key technique in the future of orthopaedic device manufacture as the cartilage replacement concept would be difficult or impossible by milling due to the thinness of the part. Developing this in the UK will benefit UK orthopaedic manufacturing, and the know-how developed will have application in other engineering fields and has the potential to increase the value of UK manufactured exports across engineering disciplines which would benefit the economy. The partnership with Renishaw is a strength in this regard, as they have a presence across engineering disiplines.

The route to commercialisation of academic research is usually through licensing or the formation of spin-out companies, and this is the likely route for the joint repair concepts developed in the proposal, under the guidance of Imperial Innovations, the university's technology transfer company. Orthopaedics is a multi-billion dollar industry, and acquisitions worth over £50m have been made for exciting technology, sometimes even with very limited supporting clinical data. A spin out company that owns the intellectual property generated during, and after the fellowship could eventually be acquired in a similar manner, therefore have tremendous benefit to the UK economy.

The potential of improving biological repair of chondral defects, or repair through cartilage substitution, has applications in sports medicine, and could be beneficial to the treatment of elite athletes. The performance of elite athletes can have great benefit to national pride, as exemplified by the recent success of Britain's elite athletes at the London Olympics.

Publications

10 25 50
publication icon
Alidousti H (2017) Spatial mapping of humeral head bone density. in Journal of shoulder and elbow surgery

publication icon
Barnes SC (2019) Micromotion and Push-Out Evaluation of an Additive Manufactured Implant for Above-the-Knee Amputees. in Journal of orthopaedic research : official publication of the Orthopaedic Research Society

publication icon
Doyle R (2019) An in vitro model of impaction during hip arthroplasty. in Journal of biomechanics

publication icon
Doyle R (2019) Effect of impaction energy on dynamic bone strains, fixation strength, and seating of cementless acetabular cups. in Journal of orthopaedic research : official publication of the Orthopaedic Research Society

publication icon
El Daou H (2019) Robotic hip joint testing: Development and experimental protocols. in Medical engineering & physics

publication icon
Han S (2018) Does Capsular Laxity Lead to Microinstability of the Native Hip? in The American journal of sports medicine

 
Description We made a very low friction hydrogel material that will be used as cartilage replacement, we have also been able to make titanium alloy bone fixation material that matches the material properties of bone. We have proven the titanium alloy in an animal model where the bone responded in the way we wanted. We also made new instruments that limit the force experienced by the patient during surgery.
Exploitation Route Work has fed into a new hip resurfacing device now in clinical trial with Embody Orthopaedic Ltd.
We set up a new spin-out Additive Instruments Ltd. to translate the additive manufacture work to clinical use.
The hip biomechanics work has led to improved surgical techniques for joint preserving hip surgery.
The patent applications cna be used as a vehicle to translate to clinical use by commercial partner.
Sectors Healthcare

 
Description The technology developed for the porous titanium is been taken up by Renishaw. Some of the testing methods were used by Embody Ltd in the design of a ceramic hip resurfacing device now in clinical trial. A patented load limiting impaction instrument was created and a spin-out company formed around the IP.
 
Description Adverse loading of the hip after joint preserving surgery
Amount £532,000 (GBP)
Funding ID EP/N006267/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 01/2016 
End 01/2018
 
Description Adverse loading of the hip joint after joint preserving and joint replacement surgery
Amount £532,259 (GBP)
Funding ID EP/N006267/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 01/2016 
End 06/2018
 
Description Capital grant for great technologies
Amount £14,000,000 (GBP)
Funding ID EP/J021199/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 01/2013 
End 01/2014
 
Description EPSRC
Amount £1,281,000 (GBP)
Funding ID EP/S021752/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 01/2019 
End 01/2024
 
Description Imperial Msk accelerator
Amount £1,000,000 (GBP)
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2018 
End 01/2022
 
Description Knowledge transfer secondment
Amount £50,000 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 10/2014 
End 10/2015
 
Description Medical Device Prototype & Manufacture Unit
Amount £1,686,000 (GBP)
Funding ID EP/R042721/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 09/2018 
End 08/2023
 
Description Renishaw/EPSRC CASE PhD studentship
Amount £100,000 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 10/2014 
End 10/2019
 
Description Research grant
Amount £70,000 (GBP)
Organisation Defence Science & Technology Laboratory (DSTL) 
Sector Public
Country United Kingdom
Start 01/2015 
End 01/2016
 
Description Translational Research Award
Amount £1,100,000 (GBP)
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 04/2013 
End 04/2018
 
Title Load limiting device for orthopaedic surgery 
Description Load limiting device for orthopaedic surgery 
IP Reference 1903271.3 
Protection Patent application published
Year Protection Granted 2019
Licensed Yes
Impact None yet
 
Title PROSTHETIC HUMERAL HEAD COMPONENT 
Description Humeral head resuracing implant design that achieves fixation proximally where the bone quality is best. 
IP Reference WO2017009655 
Protection Patent application published
Year Protection Granted 2016
Licensed No
Impact Discussions are progressing with company about licensing the tech.
 
Title Self stop drill 
Description A drill that can sense ahead of the tip via capacatance and sense when it is about to breakthrough bone. the sensing mechanism can be used to prevent plunging into soft tissue. 
IP Reference GB1814055.8 
Protection Patent application published
Year Protection Granted 2018
Licensed No
Impact In discussion with commercial partner re. licensing.
 
Title Velcro subchondral fixation 
Description We designed an active fixation surface that uses thousands of tiny barbs to fix implants in the bone. 
IP Reference WO2018055359 
Protection Patent application published
Year Protection Granted 2016
Licensed No
Impact Paper in J Orthop Research, Keynote lecture at International Society for Technology in Arthroplasty.
 
Title Embody H1 hip resurfacing 
Description Ceramic on ceramic hip resurfacing 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2017
Development Status Under active development/distribution
Clinical Trial? Yes
Impact acquisition by multinational co. Zimmer-Biomet 
URL https://clinicaltrials.gov/show/NCT03326804
 
Company Name Additive Instruments Limited 
Description The company was set up to commercialise the IP that was generated during the EPSRC research. It uses additive manufacture to make instruments for orthopaedic surgery. 
Year Established 2019 
Impact None yet.
Website https://www.additiveinstruments.com/