Novel design analysis tools to increase precision and reduce variation in hip replacement performance
Lead Research Organisation:
University of Leeds
Department Name: Mechanical Engineering
Abstract
Over 60 million patients worldwide suffer from hip osteoarthritis, and increasing numbers of patients are requiring total hip replacement surgery. Although the surgery is highly successful, the ageing active population and rise in obesity are placing extra demands on hip replacements: devices must now withstand higher loads and survive for longer durations in the body. The number of revision surgery procedures to replace worn out or damaged components is rising, and there is a need to develop more robust hip replacement devices that can withstand these increasing demands across all patient groups. One of the major causes of failure of hip replacements is due to wear and fatigue of the device components. These damage processes can increase dramatically if the components are not well aligned relative to each another, or relative to the direction of the loads they experience in the body. There can be many factors which affect the alignment, including the device design and surgical procedure as well as the patient anatomy and biomechanics.
In this proposal, we will develop computer models to simulate hip replacement performance under different misalignment conditions. We will incorporate patient and surgical variations into the model so that we can define exactly what levels of alignment are required for specific devices to operate adequately. This will enable us to provide better guidance on the choice of device for individual patients to reduce the likelihood of misalignment. It will also help inform surgeons on the positioning of the components for different patient characteristics.
We will work with a major orthopaedic company (DePuy Synthes) to integrate the computer models into their new product development process, so that the next generation of devices can be designed to be more robust to alignment variations, and surgical tools can be developed to help align devices with better precision in the most critical directions.
We will also work with regulators and standards agencies to develop new testing requirements that take account of the variations in patients and surgery, so that all new products will have to undergo more robust testing before they are introduced onto the market.
In the longer term, the methods we develop will help extend the lifetime and reliability of the next generation of hip replacements and enable these devices to meet the increasing demands of our ageing active population.
In this proposal, we will develop computer models to simulate hip replacement performance under different misalignment conditions. We will incorporate patient and surgical variations into the model so that we can define exactly what levels of alignment are required for specific devices to operate adequately. This will enable us to provide better guidance on the choice of device for individual patients to reduce the likelihood of misalignment. It will also help inform surgeons on the positioning of the components for different patient characteristics.
We will work with a major orthopaedic company (DePuy Synthes) to integrate the computer models into their new product development process, so that the next generation of devices can be designed to be more robust to alignment variations, and surgical tools can be developed to help align devices with better precision in the most critical directions.
We will also work with regulators and standards agencies to develop new testing requirements that take account of the variations in patients and surgery, so that all new products will have to undergo more robust testing before they are introduced onto the market.
In the longer term, the methods we develop will help extend the lifetime and reliability of the next generation of hip replacements and enable these devices to meet the increasing demands of our ageing active population.
Planned Impact
Over 60 million patients worldwide suffer from hip osteoarthritis and it presents an increasing burden on healthcare systems. There are growing clinical and economic needs to develop more robust, longer lasting hip replacements to meet the demands of an ageing, active population and reduce the rising cost of revision surgery.
The longer term impact of this proposal is to extend the lifetime and reliability of the next generation of hip joint replacements to meet these demands, benefitting patients, healthcare providers and the orthopaedic industry.
Through this proposal, we will develop novel design analysis and testing tools that can simulate the tribological and mechanical effects of patient and surgical variance on hip replacement performance. In the shorter term, the proposal will have impact on industry in providing new design tools for product development, clinicians in providing guidance on patient stratification for existing devices, regulatory and standard agencies in developing methods that enable surgical and patient variation to be incorporated into pre-clinical testing, and academia in developing new methodologies and highly skilled researchers, as well as promoting this application of engineering to the wider public.
For industry, we will develop computational simulation methods that can be integrated into the early design phase of new product development . We will work with Project Partner DePuy Synthes to enable the company to adopt the simulation tools in the design stage of their next generation total hip replacement systems. We will use two-way secondments between the university and DePuy Synthes as well as regular higher level meetings to ensure there is engagement throughout the project and a rapid transfer of technology. The proposed work will strengthen the capabilities of DePuy's newly opened research and development centre in Leeds, helping to drive economic growth. It will pave the way for future adoption across the industrial sector, and application to other replacement devices.
For clinicians, we will develop and validate the models on existing total hip replacement devices and use the models to identify the precision requirements beyond which detrimental tribological conditions will occur. We will investigate the effects of patient and surgical variation and use this to define improved patient stratification or surgical alignment methods for existing devices. We will work with our clinical collaborators and wider network to help disseminate findings and recommendations for current devices.
For standards and regulatory agencies, we will propose new, improved preclinical testing processes and requirements. We will use the results of our validation studies, alongside increasingly stringent performance requirements from NICE and demands from the clinical community for higher levels of compliance to advocate for improved pre-clinical testing and regulation that takes account of surgical and patient variation.
For academia, we will develop novel dynamic finite element simulation methods, as well as new techniques to incorporate patient and surgical variation in a parameterised way that enables rapid analysis of multiple variables. We will publish our methodologies and make methods and data available through our repository. We will also develop a database of patient image and gait data that will provide a resource for the wider community investigating other research questions. We will use the work to promote this application of engineering to the wider public through science fairs and patient-public engagement activities.
The longer term impact of this proposal is to extend the lifetime and reliability of the next generation of hip joint replacements to meet these demands, benefitting patients, healthcare providers and the orthopaedic industry.
Through this proposal, we will develop novel design analysis and testing tools that can simulate the tribological and mechanical effects of patient and surgical variance on hip replacement performance. In the shorter term, the proposal will have impact on industry in providing new design tools for product development, clinicians in providing guidance on patient stratification for existing devices, regulatory and standard agencies in developing methods that enable surgical and patient variation to be incorporated into pre-clinical testing, and academia in developing new methodologies and highly skilled researchers, as well as promoting this application of engineering to the wider public.
For industry, we will develop computational simulation methods that can be integrated into the early design phase of new product development . We will work with Project Partner DePuy Synthes to enable the company to adopt the simulation tools in the design stage of their next generation total hip replacement systems. We will use two-way secondments between the university and DePuy Synthes as well as regular higher level meetings to ensure there is engagement throughout the project and a rapid transfer of technology. The proposed work will strengthen the capabilities of DePuy's newly opened research and development centre in Leeds, helping to drive economic growth. It will pave the way for future adoption across the industrial sector, and application to other replacement devices.
For clinicians, we will develop and validate the models on existing total hip replacement devices and use the models to identify the precision requirements beyond which detrimental tribological conditions will occur. We will investigate the effects of patient and surgical variation and use this to define improved patient stratification or surgical alignment methods for existing devices. We will work with our clinical collaborators and wider network to help disseminate findings and recommendations for current devices.
For standards and regulatory agencies, we will propose new, improved preclinical testing processes and requirements. We will use the results of our validation studies, alongside increasingly stringent performance requirements from NICE and demands from the clinical community for higher levels of compliance to advocate for improved pre-clinical testing and regulation that takes account of surgical and patient variation.
For academia, we will develop novel dynamic finite element simulation methods, as well as new techniques to incorporate patient and surgical variation in a parameterised way that enables rapid analysis of multiple variables. We will publish our methodologies and make methods and data available through our repository. We will also develop a database of patient image and gait data that will provide a resource for the wider community investigating other research questions. We will use the work to promote this application of engineering to the wider public through science fairs and patient-public engagement activities.
Publications
Zapata-Cornelio FY
(2018)
A methodology for the generation and non-destructive characterisation of transverse fractures in long bones.
in Bone reports
Wilcox, RK
(2018)
Specimen-specific modelling as a pre-clinical evaluation tool.
Wilcox, RK
(2018)
The mechanics of musculoskeletal tissues and interventions.
Wang L
(2019)
Finite element analysis of polyethylene wear in total hip replacement: A literature review
in Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine
Vasiljeva K
(2020)
Dynamic acetabular cup version in total hip replacements patients
Vasiljeva K
(2024)
Dynamic Acetabular Cup Orientation during Gait: A Study of Fast- and Slow-Walking Total Hip Replacement Patients.
in Bioengineering (Basel, Switzerland)
Pryce GM
(2022)
Impingement in total hip arthroplasty: A geometric model.
in Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine
O'Dwyer Lancaster-Jones O
(2018)
An in vitro simulation model to assess the severity of edge loading and wear, due to variations in component positioning in hip joint replacements.
in Journal of biomedical materials research. Part B, Applied biomaterials
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
Description | We have developed new computer methods for simulating the dynamic performance of total hip replacements and evaluating the risk of adverse conditions occurring. The tools developed can be used to rapidly examine a range of different scenarios. Evidence has been generated to demonstrate the applicability and validity of different tools developed. Pilot work using clinical data (patient gait and MRI measurements) has shown how individual patient factors can affect some of these adverse risks. |
Exploitation Route | Methods are being translated to industry through engagement with Project Partner Depuy Synthes. To enable wider adoption by the sector, the methodologies have been published and presented at international conferences to both industrial, academic and clinical audiences; the computational tools have been made openly available. |
Sectors | Healthcare Manufacturing including Industrial Biotechology |
Description | Computational methods have been adopted by Project Partner Depuy Synthes to screen test variables prior to lengthy and expensive in vitro testing, to reduce time-to-market for new products and provide evidence for surgical guidance on existing products. |
First Year Of Impact | 2021 |
Sector | Healthcare,Manufacturing, including Industrial Biotechology |
Impact Types | Economic |
Description | LCR BIG Panel |
Geographic Reach | Local/Municipal/Regional |
Policy Influence Type | Membership of a guideline committee |
Impact | Membership of local economic partnership Leeds city region , west Yorkshire combined authority business Innovation growth Panel - special advisor on research innovation Universities |
Description | Med ical technology science and innovation audit |
Geographic Reach | National |
Policy Influence Type | Membership of a guideline committee |
Impact | Leadership of Medical Technology science an dInnovation audit, Leeds City region Plus |
Description | Presented 'provocation' and participated in Wellcome Health Exchange - Wellcome Trust discussion on healthy aging research chaired by Eliza Manningham-Buller (Ruth Wilcox) |
Geographic Reach | National |
Policy Influence Type | Membership of a guideline committee |
Description | international standards committee chair |
Geographic Reach | Asia |
Policy Influence Type | Membership of a guideline committee |
Impact | international pre clinical testing standards |
Description | EPSRC Healthcare Technologies Challenge Award - Sophie Williams |
Amount | £1,021,819 (GBP) |
Funding ID | EP/R003971/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 01/2018 |
End | 12/2022 |
Description | Enabling Individualised Surgical Treatment of Osteoarthritis |
Amount | £1,246,813 (GBP) |
Funding ID | EP/W003139/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 01/2022 |
End | 12/2025 |
Description | Royal Academy of Engineering Senior Research Fellowship |
Amount | £480,000 (GBP) |
Organisation | Royal Academy of Engineering |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 09/2016 |
End | 09/2021 |
Description | depuy |
Amount | £250,000 (GBP) |
Organisation | Depuy International |
Sector | Private |
Country | United Kingdom |
Start | 01/2017 |
End | 01/2018 |
Title | Dataset supporting the publication "Importance of dynamics in the finite element prediction of plastic damage of polyethylene acetabular liners under edge loading conditions" |
Description | This dataset contains the full set of output values from a modelling study, summarised as follows. After hip replacement, in cases where there is instability at the joint, contact between the femoral head and the acetabular liner can move from the bearing surface to the liner rim, generating edge loading conditions. This has been linked to polyethylene liner fracture and led to the development of a regulatory testing standard (ISO 14242:4) to replicate these conditions. Performing computational modelling alongside simulator testing can provide insight into the complex damage mechanisms present in hard-on-soft bearings under edge loading. The aim of this work was to evaluate the need for inertia and elastoplastic material properties to predict kinematics (likelihood of edge loading) and plastic strain accumulation (as a damage indicator). While a static, rigid model was sufficient to predict kinematics for experimental test planning, the inclusion of inertia, alongside elastoplastic material, was required for prediction of plastic strain behaviour. The delay in device realignment during heel strike, caused by inertia, substantially increased the force experienced during rim loading (e.g. 600 N static rigid, ~1800 N dynamic elastoplastic, in one case). The accumulation of plastic strain is influenced by factors including cup orientation, swing phase force balance, the moving mass, and the design of the device itself. Evaluation of future liner designs could employ dynamic elastoplastic models to investigate the effect of design feature changes on bearing resilience under edge loading. |
Type Of Material | Database/Collection of data |
Year Produced | 2021 |
Provided To Others? | Yes |
Impact | Dataset has enabled reuse of material for further research and training. |
URL | http://archive.researchdata.leeds.ac.uk/840/ |
Title | Dataset supporting the publication 'Computationally Efficient Modelling of Hip Replacement Separation Due to Small Mismatches in Component Centres of Rotation' |
Description | Patient imaging and explant analysis has shown evidence of edge loading of hard-on-hard hip replacements in vivo. Experimental hip simulator testing under edge loading conditions has produced increased, clinically-relevant, wear rates for hard-on-hard bearings when compared to concentric conditions. Such testing, however, is time consuming and costly. A quick running computational edge loading model (Python Edge Loading (PyEL) - quasi-static, rigid, frictionless), capable of considering realistic bearing geometries, was developed. The aim of this study was to produce predictions of separation within the typical experimental measurement error of ~0.5 mm. The model was verified and validated against comparable finite element (FE) models (including inertia and friction) and pre-existing experimental test data for 56 cases, covering a variety of simulated cup orientations, positions, tissue tensions, and loading environments. The PyEL model agreed well with both the more complex computational modelling and experimental results. From comparison with the FE models, the ashumption of no inertia had little effect on the maximum separation prediction. With high contact force cases, the ashumption of no friction had a larger effect (up to ~5% error). The PyEL model was able to predict the experimental maximum separations within ~0.3 mm. It could therefore be used to optimise an experimental test plan and efficiently investigate a much wider range of scenarios and variables. It could also help explain trends and damage modes seen in experimental testing through identifying the contact locations on the liner that are not easily measured experimentally. |
Type Of Material | Database/Collection of data |
Year Produced | 2019 |
Provided To Others? | Yes |
Impact | not yet any impact |
URL | http://archive.researchdata.leeds.ac.uk/561/ |
Title | Dataset supporting the publication 'Dynamic finite element analysis of hip replacement edge loading: balancing precision and run time in a challenging model' |
Description | This dataset contains the full set of output values from a modelling study, summarised as follows. An important aspect in evaluating the resilience of hip replacement designs is testing their performance under adverse conditions that cause edge loading of the acetabular liner. The representation of edge loading conditions in computational models is computationally challenging, however, due to the changing contact locations, need for mesh refinement, and dynamic nature of the system. In the associated paper, an initial starting point for finite element modelling of this type of testing was developed. This consisted of recommendations for aspects such as the element type and shape, and to set up the head as the translating component and fix the liner using boundary conditions. It also included recommendations for element sizing for the bulk of the liner and the contacted rim, and a mass-scaling target time increment for the elements of the liner. In the paper we present a relatively clean sensitivity study to justify these choices and describe the sensitivity of results around them so that someone putting together a new model can hopefully do so far more quickly. There was a large amount of underpinning sensitivity testing, however, which was less structured but important for getting to this final recommendation. This data packet therefore contains results from two preliminary load cases (A and B) as well as the data used in the supported paper (case C). |
Type Of Material | Database/Collection of data |
Year Produced | 2023 |
Provided To Others? | Yes |
Impact | Dataset has enabled reuse of material for further research and training. |
URL | https://archive.researchdata.leeds.ac.uk/1065/ |
Title | Dynamic acetabular cup orientation in fast and slow walking total hip replacement patients: raw motion data, processed cup angles and statistical analyses |
Description | This dataset includes the input, raw output and processes data from a study investigating the orientation of the total hip replacement acetabular cup when implanted in the pelvis and during walking gait. The associated project aimed to understand the variation in cup orientation during gait compared to its orientation within the pelvic bone on implantation. This work is motivated by the refinement of testing protocol for total hip replacement devices and the understanding of the implications of cup implantation position during surgery. Movement data are used from two sub-groups of patients, with faster and slower self-selected walking speeds post total hip replacement. And the statistical analysis looks for any differences between in the groups in terms of dynamic orientation of the acetabular cup. Correlation analysis is also included, which illustrates the relationship between pelvic orientation measurements and acetabular cup orientations. That provide information on which aspects of dynamic cup orientation can be predicted simply from single pelvic angles and which are a more complex combination of multiple angular orientations. The data itself includes tabulated measurements from every stage of the analysis from the pelvic orientation angles, through the cup angles, to the high-level statistical outcomes. |
Type Of Material | Database/Collection of data |
Year Produced | 2024 |
Provided To Others? | Yes |
URL | https://archive.researchdata.leeds.ac.uk/1223/ |
Description | DePuy partnership 2017 |
Organisation | Depuy International |
Country | United Kingdom |
Sector | Private |
PI Contribution | Research supply |
Collaborator Contribution | Funding, materials , know how, staff time |
Impact | publications multidisciplinary engineering biological sciences, medicine |
Start Year | 2017 |
Description | Depuy Kennedy 16-17 |
Organisation | Depuy International |
Country | United Kingdom |
Sector | Private |
PI Contribution | Knowledge advice |
Collaborator Contribution | knowledge expertise |
Impact | multidiciplines engineering medicine |
Start Year | 2016 |
Description | Great Yorkshire Show 11th - 13th July - Ruth Wilcox |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | Regional |
Primary Audience | Public/other audiences |
Results and Impact | iMBE regularly have an exhibit at the Great Yorkshire Show where the work conducted by all areas of the Institute is disseminated to the general public by displays, hands on models, computer screens and explanations by the participants.• Exhibit at Great Yorkshire Show, July 11-13 2017. Event attracts 130,000 with estimated 3,000 visitors to our exhibit which included 'build a knee' activity, cycling skeleton and examples of various medical devices for the knee. (organiser: Edwards; participating staff: Wilcox, Jennings, Jones, Liu) |
Year(s) Of Engagement Activity | 2017 |
Description | Hosted laboratory visit for Leeds Biomedical Research Centre Patient Public Involvement group |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | Local |
Primary Audience | Patients, carers and/or patient groups |
Results and Impact | Hosted a laboratory tour and series of talks from academic members of the Institute of Medical and Biological Engineering for members of the Leeds PPI group |
Year(s) Of Engagement Activity | 2018 |
URL | https://youtu.be/cKfs50-NxJQ |
Description | Poster presentation at Orthopaedic Research Society 2023 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation details: Cooper, N., Etchels, L.W., O'Dwyer Lancaster-Jones, O., Williams, S. and Wilcox, R.K. (2023). Experimental Characterization and Finite Element Modelling of Total Hip Replacement Liners under Edge Loading. ORS. Dallas, USA |
Year(s) Of Engagement Activity | 2023 |
Description | Presentaiton at International Society for Technology in Arthroplasty 2023 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation details: Etchels, L.W., Cooper, N., Wilcox, R.K. and Jones, A.C. (2023) Pre-Clinical Edge Loading Testing of Hip Replacements: Do We Need to Incorporate Cup Version? International Society for Technology in Arthroplasty. New York, USA |
Year(s) Of Engagement Activity | 2023 |
Description | Presentation at Computer Methods in Biomechanics and Biomedical Engineering |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation details: Jones, A et al (2023) ACETABULAR CUP ORIENTATION DURING GAIT: VARIATION AND IMPLICATIONS FOR HIP REPLACEMENT DEVICE TESTING. Computer Methods in Biomechanics and Biomedical Engineering. Paris, France. |
Year(s) Of Engagement Activity | 2023 |
Description | Presentation at Computer Methods in Biomechanics and Biomedical Engineering 2023 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation details: Etchels, L., Wilcox, R. and Jones, A. (2023). Testing THA designs under femoral head to liner rim contact conditions-using computational modelling to support and develop the methodology. Computer Methods in Biomechanics and Biomedical Engineering. Paris, France. |
Year(s) Of Engagement Activity | 2023 |
Description | Presentation at International Society Technology In Arthroplasty2023 |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Podium presentation details: S Williams, M Smeeton, G Isaac, J Anderson, R Wilcox, T Board, S Williams. Impingement During Dislocation Prone Activities of Daily Living in Dual Mobility and Standard Acetabular Cups: A Geometric Model. International Society for Technology in Arthroplasty. New York, USA. Sept 2023 |
Year(s) Of Engagement Activity | 2023 |
Description | Presentation at International Society Technology in Arthroplasty |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation details: M Smeeton, M Shuttleworth, J Anderson, G Isaac, T Board, R Wilcox, R Kay, S Williams. Monitoring of in Vitro Motion of Unconstrained Dual Mobility Polyethylene Liners for Total Hip Replacement Under Different Kinematic Conditions. International Society for Technology in Arthroplasty. New York, USA. Sept 2023 |
Year(s) Of Engagement Activity | 2023 |
Description | U3A Harrogate 10th July 2017 - Ruth Wilcox |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | Local |
Primary Audience | Public/other audiences |
Results and Impact | U3A Harrogate - explanation and dissemination of activities of the Institute of Medical & Biological Engineering |
Year(s) Of Engagement Activity | 2017 |