Agency: European Commission | Branch: FP7 | Program: BSG-SME | Phase: SME-2013-1 | Award Amount: 1.42M | Year: 2014
Approximately 800,000 hip operations are performed annually in Europe. In 56% of these operations, the components, in particular the cup, are not aligned correctly; this misalignment alters the biomechanics of the system, such that excessive wear of the cup occurs. The subsequent reduction in implant lifespan will affect ~450,000 European citizens, an average of 30,000 per year. In financial terms, the annual cost to European healthcare institutes is in the region of 426m euros, in addition to the increased likelihood of re-revision and associated aftercare costs. There are two types of navigation system currently on the market: (1) Image based which uses CT data to generate 3D preoperative images, and (2) Image-free systems which rely on kinematic data or point-clouds acquired intra-operatively to generate a 3D reconstruction that can be explored during the operation on a computer screen. Both systems have demonstrated improved accuracy over manual surgery. However, current systems entail a large initial cost (~250K) with high maintenance costs; in addition, most systems take an extra 15 minutes to setup, using valuable theatre time. The D2Eye project will develop a simple to use, low cost, fully mobile guidance system with reduced set up time. The guidance system will allow the surgeon to position the cup accurately allowing for optimum range of movement and as a result will prevent premature failure of the implant normally associated with misalignment. This will be done using a series of electronic orientation units built in to the surgical instruments which will give their position in free space. The information from the units will be projected in front of the surgeons eye in real time, allowing them to identify the correct cup implantation position; such a system will enable implant lifetimes to be extended beyond the current average 15 year lifespan, significantly reducing the burden on the healthcare system.
Agency: European Commission | Branch: FP7 | Program: BSG-SME | Phase: SME-1 | Award Amount: 1.48M | Year: 2009
Each year in Europe there are:- 800000 hip operations costing approximately 1,942 per/implant, worth over 1.5 billion Hip implant operations are rising by approximately 15%. Currently 10% of all the prosthesis implanted are in patients under 55 years of age of which 33% of these will fail within 16 years with a further 20% of implant fitted to over 55s failing with in 20 years requiring revisional surgery costing 2.3 billion per annum. Treatment of younger patients with severe hip disease using a conventional THR presents a challenge with the rate of success being very low, (most failing within 16 years). To over come this Finsbury help develop the MoM BHR resurfacing hip with a survival rate of 93% over a conventional THR. However, studies have reported high concentrations of Co & Cr in the serum and/or urine of patients with MoM resurfacing implants. Studies have shown that increased levels of Co & Cr cause caners such as leukaemia and are linked with myocardiopathy. During the course of this project we intend to overcome these problems by developing a ceramic one ceramic or ceramic on polymer resurfacing hip. Like that of the MOM prosthesis will only cover the femoral head thus retaining all of the desirable properties associated with retaining an intact femur.
Esposito C.I.,Specialist Orthopaedic Group |
Walter W.L.,Specialist Orthopaedic Group |
Roques A.,Specialist Orthopaedic Group |
Roques A.,Aurora Medical Ltd |
And 6 more authors.
Journal of Bone and Joint Surgery - Series B | Year: 2012
We analysed 54 alumina ceramic-on-ceramic bearings from total hip replacements retrieved at one centre after a mean duration of 3.5 years (0.2 to 10.6) in situ. These implants were obtained from 54 patients (16 men and 38 women) with a mean age of 67 years (33 to 88) who underwent revision for a variety of reasons. Posterior edge loading was found in the majority of these retrievals (32 out of 54). Anterosuperior edge loading occurred less often but produced a higher rate of wear. Stripe wear on the femoral heads had a median volumetric wear rate of 0.2 mm3/year (0 to 7.2). The wear volume on the femoral heads corresponded to the width of edge wear on the matching liner. Anteversion of the acetabular component was found to be a more important determinant than inclination for wear in ceramic bearings. Posterior edge loading may be considered to be a normal occurrence in ceramic-on-ceramic bearings, with minimal clinical consequences. Edge loading should be defined as either anterosuperior or posterior, as each edge loading mechanism may result in different clinical implications. ©2012 British Editorial Society of Bone and Joint Surgery.
Gillard F.C.,University of Southampton |
Dickinson A.S.,University of Southampton |
Schneider U.,Fraunhofer Institute for Manufacturing Engineering and Automation |
Taylor A.C.,Aurora Medical Ltd. |
Browne M.,University of Southampton
Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine | Year: 2013
The shape of the acetabular cartilage follows the contact stress distribution across the joint. Accurate characterisation of this geometry may be useful for the development of acetabular cup devices that are more biomechanically compliant. In this study, the geometry of the acetabular cartilage was characterised by taking plaster moulds of the acetabulum from 24 dry bone human pelvises and digitising the mould shapes using a three-dimensional laser scanner. The articular bone surface geometry was analysed, and the shape of the acetabulum was approximated by fitting a best-fit sphere. To test the hypothesis that the acetabulum is non-spherical, a best-fit ellipsoid was also fitted to the geometry. In each case, points around the acetabular notch edge that disclosed the articular surface geometry were identified, and vectors were drawn between these and the best-fit sphere or ellipsoid centre. The significantly larger z radii (into the pole) of the ellipsoids indicated that the acetabulum was non-spherical and could imply that the kinematics of the hip joint is more complex than purely rotational motion, and the traditional ball-and-socket replacement may need to be updated to reflect this motion. The acetabular notch edges were observed to be curved, with males exhibiting deeper, wider and shorter notches than females, although the difference was not statistically significant (mean: p = 0.30) and supports the use of non-gender-specific models in anatomical studies. © IMechE 2013.
Dickinson A.S.,University of Southampton |
Dickinson A.S.,Aurora Medical Ltd. |
Taylor A.C.,Aurora Medical Ltd. |
Browne M.,University of Southampton
Journal of Biomechanics | Year: 2012
Acetabular cup loosening is a late failure mode of total hip replacements, and peri-prosthetic bone deterioration may promote earlier failure. Preservation of supporting bone quality is a goal for implant design and materials selection, to avoid stress shielding and bone resorption. Advanced polymer composite materials have closer stiffness to bone than metals, ceramics or polymers, and have been hypothesised to promote less adverse bone adaptation. Computer simulations have supported this hypothesis, and the present study aimed to verify this experimentally.A composite hemi-pelvis was implanted with Cobalt Chromium (CoCr), polyethylene (UHMWPE) and MOTIS ®carbon-fibre-reinforced polyether etherketone (CFR-PEEK) acetabular cups. In each case, load was applied to the implanted pelvis and Digital Image Correlation (DIC) was used for surface strain measurement. The test was repeated for an intact hemi-pelvis. Trends in implanted vs. intact bone principal strains were inspected to assess the average principal strain magnitude change, allowing comparison of the potential bone responses to implantation with the three cups.The CFR-PEEK cup was observed to produce the closest bone strain to the intact hip in the main load path, the superior peri-acetabular cortex (+12% on average, R 2=0.84), in comparison to CoCr (+40%, R 2=0.91) and UHWMPE cups (-26%, R 2=0.94). Clinical observations have indicated that increased periacetabular cortex loading may result in reduced polar cancellous bone loading, leading to longer term losses in periprosthetic bone mineral density. This study provides experimental evidence to verify previous computational studies, indicating that cups produced using materials with stiffness closer to cortical bone recreate physiological cortical bone strains more closely and could, therefore, potentially promote less adverse bone adaptation than stiffer press-fitted implants in current use. © 2011 Elsevier Ltd.
Agency: GTR | Branch: Innovate UK | Program: | Phase: European | Award Amount: 274.34K | Year: 2015
Agency: GTR | Branch: Innovate UK | Program: | Phase: Feasibility Study | Award Amount: 83.67K | Year: 2016
The BIOCOAT project is a technical feasibility study to will allow the application of existinv coating processes to a new area, from the single use disposable medical device field to the long term implantation field. BioInteractions Ltd and Aurora Medical Ltd are coming togheter to build the coating technology block required to develop a novel, minimally invasive implant and procedure. This would provide a cost effective solution, in particular for the older frail patient group in which joint replacement operations have high complication rates, and as an alternative to NSAIDs for the treatement of arthritis pain. In the context of an ageing population and increasing obesity as well as the econmic pressure facing health services worldwide, the innovative implant would allow NHS savings of more than £130m per year 5 years after the start of the clincal trial, and offer a novel, cost effective solution to Health Services worldwide. In the longer term the type of technology developed inthis project will provide a strong competitive advantage to the UK and Europe.
Agency: GTR | Branch: Innovate UK | Program: | Phase: Collaborative Research & Development | Award Amount: 48.38K | Year: 2017
Although total hip replacement is one of the most successful operations performed worldwide, with 1.6 million hip operations recorded in developed countries in 2011, there is a 5-10% risk of revision at 10 years. It is known that patients’ specificities affect the risk of long term failure. With the increase in longevity and obesity, the orthopaedic market will continue to grow, with a drive to reduce implant and operation costs to relieve the burden on health services. We aim to translate results from our extensive R&D experience in orthopaedic products performance into a cost effective service offering for the patients benefit, in the shortest timescales possible. A novel, low cost assessment methodology that can be used in a standard clinical setting will be offered to the surgeon/patient team during pre-clinical assessment, to identify patients that may have an increased long term failure risk. In the longer term, this may also be used post-operatively to optimise re-education/recovery.
Aurora Medical Ltd | Date: 2015-08-12
An implant for an articulating two-component joint, said implant comprising a sac and a filler material located within the sac, said sac having an external surface which in use contacts bone or cartilage of the joint and which has a coefficient of friction such that it does not move relative to the bone or cartilage with which it is in contact during articulation and said filler has a coefficient of friction that allows opposite sides of the sac to move relative to one another when a force is applied.
Agency: GTR | Branch: Innovate UK | Program: | Phase: Collaborative Research & Development | Award Amount: 341.61K | Year: 2014
The Virtual Patient Software is an industrial research project that will allow Aurora Medical Ltd to up-skill in order that they are ultimately in a position to offer a service to the orthopaedic community, whereby a statistical model of human joints will be utilised to predict implant outcomes. The proof of concept model already established at the University of Southampton will be developed so that this can support a significant reduction in the number of prototypes required during the development and clinical trial phases of new implant product market introduction, whilst improving the safety of those devices by accounting for the inherent variability in patients (including physiology and loading) and surgical factors. We anticipate that the costs of development to clinical trials can be reduced by 75%, with reduced timescales by 10%. By being able to account for some of the biomechanical factors that affect revision outcome (cases such as aseptic loosening, implant fracture, malignement and wear), in the longer term, the Virtual Patient Software will also have a significant impact on revision rates, and on the costs burden these represent on National Health Services.