Programme Grant Application in Bio Tribology of Articular Cartilage and Substitution Interventions
Lead Research Organisation:
University of Leeds
Department Name: Mechanical Engineering
Abstract
Osteoarthritis affects at least 15% of the population. Currently, apart from pharmacological intervention and pain relief the only effective treatment is end stage total joint replacement. Current total joint replacement surgery is highly successful in patients over 65 with relatively low demands, with success rates over 90% at ten years. Osteoarthritis is being diagnosed in increasing numbers of younger and more active patients, who have expectations of an active life style and desire to remain functional and working for extended periods. However, current joint replacement is not as successful in younger patients, with long term wear and osteolysis in the hip and knee, associated with loss of fixation/bone, loosening and higher revision rates. Revision of failed prostheses is currently a large operating burden in the NHS, and these operations are generally more expensive with increased morbidity compared to primary arthroplasty. There is a reluctance to utilise end stage joint replacement in younger and more active patients, and there is a desire to develop tissue sparing substitution treatments and regenerative treatments for early degenerative disease in articulating joints. There is a need to develop research capacity in the functional biotribology of articular cartilage to support research and development of cartilage substitution therapies and regenerative interventions and enable a new generation of pre-clinical studies to be undertaken to accelerate of the translation of new technology to the patient and enhance the safety and efficacy through better short term predictions of long term clinical outcomes.The overall aim of this programme is to develop a new research platform to study the biotribology of full scale, whole natural joints, over extended periods of time, under representative physiological and anatomical conditions (through in vitro experimental and computational models). Once established these novel simulation systems for cartilage biotribology will allow us to work collaboratively with academic and industrial groups to investigate and support development of new surgical interventions for cartilage substitution and regenerative therapies for early intervention in osteoarthritis. Three important natural articulating joint systems of the hip, the knee and the spine will be addressed. The findings from the programme grant will be valuable in helping industry and manufacturers of advanced medical products to develop improved and safer intervention therapies, and for surgeons to make better informed about decisions on use of new therapies. The work will also inform regulatory and standard bodies such as MHRA (UK), FDA (USA) and ISO. This will have tremendous economic benefit to the UK NHS as well as social benefit to the patients.
Publications
Zapata-Cornelio F
(2017)
Methodology to Produce Specimen-Specific Models of Vertebrae: Application to Different Species
in Annals of Biomedical Engineering
Taylor SD
(2012)
Comparison of human and animal femoral head chondral properties and geometries.
in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine
Stops AJ
(2012)
An analytical calculation of the fluid load support fraction in a biphasic material: an alternative technique.
in Journal of the mechanical behavior of biomedical materials
Stops A
(2012)
Computational modelling of the natural hip: a review of finite element and multibody simulations.
in Computer methods in biomechanics and biomedical engineering
Mengoni M
(2016)
Subject-specific multi-validation of a finite element model of ovine cervical functional spinal units.
in Journal of biomechanics
Meng Q
(2013)
Comparison between FEBio and Abaqus for biphasic contact problems.
in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine
Meng Q
(2017)
The effect of collagen fibril orientation on the biphasic mechanics of articular cartilage.
in Journal of the mechanical behavior of biomedical materials
Meng Q
(2013)
Contact mechanics and lubrication analyses of ceramic-on-metal total hip replacements
in Tribology International
Meng Q
(2015)
The lubrication performance of the ceramic-on-ceramic hip implant under starved conditions.
in Journal of the mechanical behavior of biomedical materials
Meng Q
(2014)
Computational investigation of the time-dependent contact behaviour of the human tibiofemoral joint under body weight.
in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine
Lizhang J
(2013)
Effect of clearance on cartilage tribology in hip hemi-arthroplasty.
in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine
Liu A
(2014)
Generation of a large volume of clinically relevant nanometre-sized ultra-high-molecular-weight polyethylene wear particles for cell culture studies.
in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine
Liu A
(2015)
Tribology studies of the natural knee using an animal model in a new whole joint natural knee simulator.
in Journal of biomechanics
Li J
(2014)
Influence of clearance on the time-dependent performance of the hip following hemiarthroplasty: a finite element study with biphasic acetabular cartilage properties.
in Medical engineering & physics
Li J
(2014)
Hip contact forces in asymptomatic total hip replacement patients differ from normal healthy individuals: Implications for preclinical testing
in Clinical Biomechanics
Li J
(2015)
Unilateral total hip replacement patients with symptomatic leg length inequality have abnormal hip biomechanics during walking.
in Clinical biomechanics (Bristol, Avon)
Li J
(2013)
The influence of size, clearance, cartilage properties, thickness and hemiarthroplasty on the contact mechanics of the hip joint with biphasic layers.
in Journal of biomechanics
Li J
(2016)
The influence of the representation of collagen fibre organisation on the cartilage contact mechanics of the hip joint.
in Journal of biomechanics
Li J
(2014)
Biphasic investigation of contact mechanics in natural human hips during activities.
in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine
Li J
(2014)
Experimental validation of a new biphasic model of the contact mechanics of the porcine hip.
in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine
Hua X
(2015)
Geometric parameterisation of pelvic bone and cartilage in contact analysis of the natural hip: an initial study.
in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine
Hogg P
(2015)
Development of a terminally sterilised decellularised dermis.
in Cell and tissue banking
Hasan J
(2014)
Current strategies in meniscal regeneration.
in Journal of biomedical materials research. Part B, Applied biomaterials
Fermor HL
(2015)
Development and characterisation of a decellularised bovine osteochondral biomaterial for cartilage repair.
in Journal of materials science. Materials in medicine
Al-Hajjar M
(2013)
Wear of novel ceramic-on-ceramic bearings under adverse and clinically relevant hip simulator conditions.
in Journal of biomedical materials research. Part B, Applied biomaterials
Abdelgaied A
(2015)
Comparison of the biomechanical tensile and compressive properties of decellularised and natural porcine meniscus.
in Journal of biomechanics
Description | We have developed substantial research capacity and capability, in experimental and computational simulation systems, and fundamental knowledge of the "bio-tribology of articular cartilage and substitution interventions" through full scale anatomical and physiological in vitro models. We have established a world leading position in "natural joint" bio-tribology, which replicates and is equivalent to the position we have previously established in bio-tribology of total artificial joint replacements. This is allowing us to work collaboratively with academic and industrial groups worldwide to support the development of tissue substitution and early interventions osteoarthritis (OA) in the younger and more active population. Footnote Articular cartilage is short hand for the natural joint, bone, cartilage and related tissue structures. Bio- tribology includes studies of biomechanics, kinematics, dynamics and structure-function relationships. Specific achievements and findings Novel multidirectional pin on plate tribological simulator for natural bone and cartilage Long term organ culture of articulating surfaces of natural knee Long term loading, sliding and organ culture of articulating surfaces of natural knee A novel six axis biomechanical and biotribological simulation system of natural knee A new biphasic computational model of biomechanics and biotribology of natural knee A novel six axis biomechanical and biotribological simulation system of natural hip A new biphasic computational model of biomechanics and biotribology of natural hip A new biphasic computational model of biomechanics biotribology of natural functional spinal unit A six axis simulator for the spine High resolution imaging and metrology methods to support biotribology and biomechanical simulations |
Exploitation Route | Commercilised as products by Simulation Solutions Fee for service contracts for research and product development, design and manufacture through the Univeristy of Leeds, to global industry Industry partners include DePuy Tissue Regenix In vibio NHSBT Simulation Solutions All above experiemtnal simulation systems have been developed in collaboration with simulation solutions and are now available as commercial products Our world leading novel experimental facilties are being used for coalborative academic, clincial and industrial research Computational models are being used in collaborative research, for collaborative clincial research and as a fee for service for industry research and consutancy |
Sectors | Healthcare |
URL | http://imbe.leeds.ac.uk |
Description | Development of natural joint simulators by Simulation Solutions Development and approval of new international standard Development of acellular scaffolds by NHSBT and Tissue Regenix DCell skin Dermapure marketed globally DCell ligaments completed clinical trial Development of acellular bone patellar bone graft by NSBT Having completed clinical study, now supplied as a clinical product |
First Year Of Impact | 2015 |
Sector | Healthcare |
Impact Types | Societal,Economic |
Description | international standards committee chair |
Geographic Reach | Asia |
Policy Influence Type | Membership of a guideline committee |
Impact | international pre clinical testing standards |
Description | Biocomposites |
Amount | £200,000 (GBP) |
Funding ID | LMJ |
Organisation | Biocomposites |
Sector | Private |
Country | United Kingdom |
Start | 01/2013 |
End | 01/2016 |
Description | Biomedical research unit |
Amount | £6,000,000 (GBP) |
Funding ID | Leeds musculoskeletal biomedical research unit |
Organisation | National Institute for Health Research |
Sector | Public |
Country | United Kingdom |
Start | 03/2014 |
End | 03/2017 |
Description | CDT 2014-22 |
Amount | £4,000,000 (GBP) |
Funding ID | CDT TERM |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 05/2014 |
End | 09/2022 |
Description | DTC 208-2017 |
Amount | £7,000,000 (GBP) |
Funding ID | DTC |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 05/2008 |
End | 09/2017 |
Description | DTP |
Amount | £2,000,000 (GBP) |
Funding ID | DTP |
Organisation | DePuy Synthes |
Sector | Private |
Country | United States |
Start | 01/2014 |
End | 01/2016 |
Description | European Research Council advanced award |
Amount | £2,000,000 (GBP) |
Funding ID | Proposal 267114 |
Organisation | European Research Council (ERC) |
Sector | Public |
Country | Belgium |
Start | 03/2011 |
End | 04/2016 |
Description | Healthcare Technologies Programme Grant |
Amount | £3,962,447 (GBP) |
Funding ID | EP/N02480X/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 09/2016 |
End | 09/2021 |
Description | IKC |
Amount | £10,000,000 (GBP) |
Funding ID | "EP G0324831, EPI0191031, EPJ0176201" |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 03/2009 |
End | 04/2016 |
Description | Medical engineering centre |
Amount | £4,200,000 (GBP) |
Funding ID | WELMEC |
Organisation | Wellcome Trust |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 09/2014 |
End | 09/2015 |
Description | NHSBT |
Amount | £200,000 (GBP) |
Funding ID | EI |
Organisation | NHS Blood and Transplant (NHSBT) |
Sector | Public |
Country | United Kingdom |
Start | 01/2014 |
End | 01/2017 |
Description | Tissue regenix |
Amount | £60,000 (GBP) |
Funding ID | EI |
Organisation | Tissue Regenix Ltd |
Sector | Private |
Country | United Kingdom |
Start | 01/2016 |
End | 01/2018 |
Description | invibio |
Amount | £400,000 (GBP) |
Funding ID | LMJ |
Organisation | Invibio |
Sector | Private |
Country | United Kingdom |
Start | 01/2014 |
End | 12/2016 |
Description | senior investigator |
Amount | £100,000 (GBP) |
Funding ID | LMBRU |
Organisation | National Institute for Health Research |
Sector | Public |
Country | United Kingdom |
Start | 03/2014 |
End | 04/2015 |
Title | Hip Joint simulator |
Description | In vitro simulator for artificial hip joints |
Type Of Material | Model of mechanisms or symptoms - in vitro |
Year Produced | 2013 |
Provided To Others? | Yes |
Impact | Method commercialised by Simulation Solutions |
Title | Knee joint simulator |
Description | artificial knee joint simulator |
Type Of Material | Model of mechanisms or symptoms - in vitro |
Year Produced | 2013 |
Provided To Others? | Yes |
Impact | Simulator and simulation method commercialised by simulation solution |
Title | Natural knee simulator |
Description | Simulation system for natural knee |
Type Of Material | Model of mechanisms or symptoms - in vitro |
Year Produced | 2013 |
Provided To Others? | Yes |
Impact | Simulator commercially available, Simulation Solutions |
Title | natural hip simulator |
Description | Simulation system for natural hip |
Type Of Material | Model of mechanisms or symptoms - mammalian in vivo |
Year Produced | 2014 |
Provided To Others? | Yes |
Impact | System commercially availa le from Simulation Solutions |
Title | spine simulator |
Description | Spinal disc simulator |
Type Of Material | Model of mechanisms or symptoms - in vitro |
Year Produced | 2012 |
Provided To Others? | Yes |
Impact | Commercialised by Simulation solutions |
Title | Biomechanical and biotribological simulation model natural hip |
Description | Biomechanical and biotribological model of natural hip |
Type Of Material | Computer model/algorithm |
Year Produced | 2013 |
Provided To Others? | Yes |
Impact | used in follow on research |
Title | Biomechanical model of functional spinal unit |
Description | model of functional spinal unit |
Type Of Material | Computer model/algorithm |
Year Produced | 2014 |
Provided To Others? | Yes |
Impact | used in follow on research |
Title | Biotribological model naturala knee |
Description | Biotribological model natural knee |
Type Of Material | Computer model/algorithm |
Year Produced | 2014 |
Provided To Others? | Yes |
Impact | Used in follow on research on regenerative devices |
Title | Data associated with 'Development of a specimen-specific in vitro pre-clinical simulation model of the human cadaveric knee with appropriate soft tissue constraints' |
Description | The dataset will include all the data. for figures in the manuscripts as shown in the followings: 1) Kinematic input profiles for the human cadaveric knee. 2) Average AP displacement and TR angle of the 4 human knee specimens in a human walking gait cycle (both AP and TR force driven condition). 3) Typical kinematic profiles from one donor under different spring conditions for different spring rates and free lengths/degrees 4) Comparison of kinematic profiles (AP displacement and TR angle) of the intact knee and the most appropriate spring constraints from four human knee specimens. |
Type Of Material | Database/Collection of data |
Year Produced | 2020 |
Provided To Others? | Yes |
URL | http://archive.researchdata.leeds.ac.uk/736/ |
Title | wear simulation model artificial hip |
Description | wear simulation model artificial hip |
Type Of Material | Computer model/algorithm |
Year Produced | 2010 |
Provided To Others? | Yes |
Impact | applied in industry contract research |
Title | wear simulation model artificial knee |
Description | wear simulation model artificial knee |
Type Of Material | Computer model/algorithm |
Year Produced | 2012 |
Provided To Others? | Yes |
Impact | used in industry contract research |
Description | DePUY International Ltd |
Organisation | Depuy International |
Country | United Kingdom |
Sector | Private |
Start Year | 2004 |
Description | DePuy |
Organisation | Depuy International |
Country | United Kingdom |
Sector | Private |
PI Contribution | Thirty-three projects. |
Collaborator Contribution | funds , materilas staff |
Impact | publications |
Start Year | 2013 |
Description | Depuy International Ltd |
Organisation | Depuy International |
Country | United Kingdom |
Sector | Private |
Start Year | 2004 |
Description | Depuy International Ltd |
Organisation | Depuy International |
Country | United Kingdom |
Sector | Private |
Start Year | 2003 |
Description | NAMSA |
Organisation | North American Science Associates Inc |
Country | United States |
Sector | Private |
PI Contribution | In vivo testing of dCell bone to detremine osseointegration and biocompatibility |
Collaborator Contribution | undertaking research work |
Impact | pubication |
Start Year | 2015 |
Description | National Blood Service |
Organisation | NHS Blood and Transplant (NHSBT) |
Department | National Blood Service |
Country | United Kingdom |
Sector | Public |
Start Year | 2003 |
Description | Simulation Solutions |
Organisation | Simulation Solutions |
Country | United Kingdom |
Sector | Private |
PI Contribution | 10 projects in collaboration with Simulation Solutions: High flex knee simulator Natural knee simulator Natural hip simulator Natural spine simulator Natural joint friction simulator knee joint simulator SOP for hip simulator SOP for knee simulator Natural Knee Simulation System Electro mechanical hip simulator method SOP and training |
Collaborator Contribution | equipment development |
Impact | publications |
Start Year | 2014 |
Description | Tissue Regenix |
Organisation | Tissue Regenix Ltd |
Country | United Kingdom |
Sector | Private |
PI Contribution | A total of 12 projects collaborating with Tissue Regenix Acellular ligament graft (Animal) Acellular bone meniscus bone graft (Animal) Acellular OC graft (Animal) Xeno vascular patch Xeno heart valve Decellularised bladder Decellularised meniscus (see also 12b) Acellular porcine flexor tendon graft Development of the dCELL Partial Meniscus In vivo testing of dCell bone to determine osseointegration and biocompatibility In vivo evaluation of decellularised porcine pulmonary roots. Long Term Evaluation of an Acellular Bovine Arterial Graft in an Ovine Arteriovenous Access Model |
Start Year | 2009 |
Description | Tissue Regenix Ltd |
Organisation | Tissue Regenix Ltd |
Country | United Kingdom |
Sector | Private |
PI Contribution | research |
Collaborator Contribution | materials Ip |
Impact | papers |
Start Year | 2014 |
Title | ISO accredited simulation test laboratory |
Description | ISO accredited simulation test laboratory for pre clinical testing and trials widely used by customers around globe |
Type | Support Tool - For Medical Intervention |
Current Stage Of Development | Wide-scale adoption |
Year Development Stage Completed | 2013 |
Development Status | Under active development/distribution |
Impact | uptake by wide range of companies |
Title | acellular bone |
Description | under development and in in vivo trials |
Type | Therapeutic Intervention - Medical Devices |
Current Stage Of Development | Refinement. Non-clinical |
Year Development Stage Completed | 2014 |
Development Status | Under active development/distribution |
Impact | under development and in animal trials |
Title | acellular bone cartilage osteochondral graft |
Description | under development |
Type | Therapeutic Intervention - Medical Devices |
Current Stage Of Development | Initial development |
Year Development Stage Completed | 2014 |
Development Status | Under active development/distribution |
Impact | under developemnt |
Title | acellular bone cartilage osteochondral graft |
Description | under development NHSBT |
Type | Therapeutic Intervention - Medical Devices |
Current Stage Of Development | Initial development |
Year Development Stage Completed | 2015 |
Development Status | Under active development/distribution |
Impact | under development |
Title | dcell ligament |
Description | Under commercial development by tissue Regenix, progressing to CE mark and product launch |
Type | Therapeutic Intervention - Medical Devices |
Current Stage Of Development | Refinement. Non-clinical |
Year Development Stage Completed | 2014 |
Development Status | Under active development/distribution |
Clinical Trial? | Yes |
Impact | under commercial development by Tissue Regenix in clinical trial started 2015 proceeding to Ce mark and product launch 2017 |
URL | https://clinicaltrials.gov/show/NCT02540811 |
Title | dcell meniscus |
Description | Developed by tissue Regenix In clinical trial started 2015 |
Type | Therapeutic Intervention - Medical Devices |
Current Stage Of Development | Late clinical evaluation |
Year Development Stage Completed | 2014 |
Development Status | Under active development/distribution |
Clinical Trial? | Yes |
Impact | first in man clinical trial started 2015 |
URL | https://clinicaltrials.gov/show/NCT02270905 |
Title | finite element simulation tools to capture patient variation for the analysis of orthopaedic devices across a patient cohort |
Description | This project has been led by Dr Ruth Wilcox in partnership with Simpleware Limited. The development of the software add-on has been completed and the final validations with the Leeds data set-set are coming to an end. It is anticipated that a technology demonstrator project will now be undertaken with a company that can demonstrate the utility of the software for evaluating spinal implants. The commercial team is now engaged and discussions with Simpleware around a possible license deal are on-going. It is envisaged that as part of this license deal Simpleware will engage Leeds expertise as part of their offer to companies. In addition Leeds personnel will retain the right to undertake consultancy in their own capacity. |
Type Of Technology | Software |
Year Produced | 2013 |
Impact | further research |
Title | natural hip simulator |
Description | natural hip simulator |
Type Of Technology | Physical Model/Kit |
Year Produced | 2014 |
Impact | commercial product simulation solutions |
Title | natural knee simulator |
Description | natural knee simulator |
Type Of Technology | Physical Model/Kit |
Year Produced | 2013 |
Impact | commercialised by simulation solutions |
Company Name | Tissue Regenix |
Description | Developemnt and manufacture of Regenerative Biological Scaffolds for tissue repair in vascular, cardiovascular and musculoskeletal systems |
Year Established | 2007 |
Impact | aim listed d raised £0m investment value £150m 4 clinical products |