Project: Innovative 3D planning and simulation for Hip and Knee arthroplasty

Osteoarthritis (OA) is a debilitating condition, which affected more than 81.4 million people in the five major European markets, the USA and Japan in 2009, with a prevalence expected to grow by over 10 millions by 2020 (Datamonitor, 2009). The pain resulting from severe disease can be reduced through the use of implantation solutions such as joint replacement._x000D__x000D_A successful implantation depends on proper implant selection and positioning to restore functional anatomy, without pain, and to prevent the early wear of the implant. _x000D_But the opposite is also true – that wrong implant selection and positioning may lead to deformities (length discrepancy > 5mm, varus/valgus) and to a poor load transfer between the implant and bone. This is the outcome of ±10% of implants resulting in the need for undertaking further early implant replacement or revision surgery._x000D__x000D_Let us focus on total knee arthroplasty (TKA) and total hip arthroplasty (THA), which are the two CO operations on people affected with OA worldwide:_x000D__x000D_- TKA is the most performed joint replacement (400 000 TKAs/year in the USA, 430 000 in the EU) with the highest rate of joint replacement revisions (19.3%), which most commonly (35.2% of cases) derive from a surgical error after the mal-positioning of the implant (AAOS & KSSTA, 2010). _x000D_As the demand for TKA is expected to double by 2015, it will place a huge burden on healthcare systems. In 2009, the average hospital charges were $49,360 per revision TKA (JBJS, 2009)._x000D__x000D_- More than 235 000 THA are performed each year in the USA and 487 000 in the EU (and expected to grow by 174% by 2030) with an average revision rate of 15%. Health insurers estimate that the cost of a prosthesis revision exceeds the cost of the primary hip replacement in 29% of cases (JBJS, 2009)._x000D__x000D_The number of implant revision surgery could be reduced if surgeons could benefit from more accurate and relevant information to plan and execute arthroplasty, and the cost of each surgery could be reduced by a more accurate planning._x000D__x000D_Whilst high tech advances such as medical robotics, computer-assisted surgery and image-guided technologies, minimally invasive joint replacement surgery and bio-engineered technologies represent real progress in the field of orthopaedic surgery, surgeons still do not have easy and fast access to accurate clinical information at the right times before, during and after implantation. _x000D_The imaging systems commonly used for pre-op examination (planar radiography) fall short because: _x000D_- In most cases, only local images are done; so global anatomical measurements are either estimated or ignored,_x000D_- 2D measurements on planar X-ray images suffer from projection systematic errors but the choice and positioning of an implant is made by placing an overlay of a 2D transparency over a 2D radiograph,_x000D_- There is no 3D planning for implants._x000D__x000D_Recent introduction of a new imaging modality named EOS, which generates bi-plane digital images of a full body in a weight bearing position, may change the paradigm by allowing better access to 3D information._x000D__x000D_In this context, EOS Imaging (EOSIM, France), developer of this system based on Nobel Prize winning detection technology, and 4plus, a German SME specialized in computer assisted planning of surgical interventions, have decided to combine their skills and, with the support of the center of excellence for sensor data processing from the University of Siegen (USIEGEN), undertake the IMPLANNER project. This 24-month program is aimed at developing a new planning and simulation tool for THA and TKA that will support the entire treatment workflow in a 3D image environment through: _x000D_1/ Pre-operative support (selection of the implant done by an expert system using implant 3D models and 3D information on patient anatomy and implant positioning on patient images undertaken with respect to anatomical 3D landmarks and by assessing in real time the quantitative impact on 3D parameters describing the patient’s lower limb)_x000D_2/ Intra-operative support (transfer to the Operating Room (OR) the extensive results of the planning in a 3D referential linked to the patient’s specific anatomy)_x000D_3/ Post-operative support (post-op location of the implant undertaken using the same patient-dependent 3D referential to enable pre- and post-op comparisons). _x000D__x000D_The tool will offer a new approach to improve the outcome of implant surgery tailored to the surgeon’s needs and driven by the patient’s anatomy based on:_x000D_- creating a detailed and homogeneous 3D image environment_x000D_- providing a customized expert system to assist in implant selection and positioning_x000D_- offering a more comprehensive set of information to guide pre-operative planning - predicting the results of surgery and quantifying the follow-up._x000D__x000D_The overall expected benefit of the project will be to provide every patient with an optimized implant procedure and to reduce the risk of implant revision and post-op complications to the lowest possible level. _x000D_

Acronym	IMPLANNER (Reference Number: 6929)
Duration	01/08/2012 - 30/09/2014
Project Topic	Development of a new software application to plan hip and knee arthroplasty in 3D, simulate the impact of implant choice and placement on 3D anatomical parameters characterizing the patient's lower limb, transfer the planning information to the operating room and assess post-op 3D results
Project Results (after finalisation)	The three Ps got significative outcomes in terms of innovation, technology transfers and scientific progress._x000D_1. Several product introductions by the two industrial Ps : Modicas||plan 2D and sterEOS 3D have been introduced on the market (CE marking and approval in US as medical devices). _x000D_2. Several proof of concepts and prototypes on going for future generations of products on WP2, WP3 and WP4.
Network	Eurostars
Call	Eurostars Cut-Off 7

Project partner

Number	Name	Role	Country
3	4plus	Partner	Germany
3	EOS imaging	Coordinator	France
3	University of Siegen Center for Sensor Systems (ZESS)	Partner	Germany