Periodic Reporting for period 2 - CuraBone (Predictive models and simulations in bone regeneration: a multiscale patient-specific approach)
Período documentado: 2019-04-01 hasta 2021-03-31
Bone injuries generate high costs for the European health system. Currently different types of surgeries are conducted, depending on the fracture or bone deformation of the patient. Corrective surgeries are commonly used to improve patients' situation. Traditionally, the treatment relies on classical orthopaedic techniques, but nowadays it is possible to design and fabricate patient-specific implants. Also scaffolds – bone like structures replacing bone - can be printed easily with spongy structures.
Thanks to the current advances in image-based technologies, the patients' bone shape can be replicated with a 3D-model and even 3D-printed. Using imaging techniques like CT or MRI helps to visualize the actual inner structures of a patient. Well-fitted 3D-models of implants or scaffolds can be designed directly on the patients' actual surface of his/her broken bone. Although, it is not possible to predict the outcome of different treatments (bone ingrowth into the implant, healing and regeneration). In fact, surgeons, clinical engineers and industry should develop the implant together to ensure the best outcome.
CuraBone aimed to bridge the gap between research and Industry, focusing on three main orthopaedic applications: knee and shoulder joints and cranio-maxillofacial surgery and additionally evaluated different bioresorbable and non-resorbable scaffold solutions. To accomplish this aim, CuraBone has comprised three objectives. First, musculoskeletal patient-specific models were created. These models used individual patient data like bone geometries or muscle attachment locations to calculate the loads acting on the bone-implant-composition. Second, a computational-based platform was developed to simulate the impact of therapeutic treatment, optimizing the design of implants and providing personalized rehabilitation therapies. Finally, a systematic methodology was implemented to validate the developed computational models. A quantitative comparison between clinical and numerical results was conducted resulting in accurate personalized predictive models for each situation.
The three objectives were successfully achieved during CuraBone development. Using computer simulation technologies CuraBone has achieved optimized, patient-specific treatments of bone injuries and rehabilitation therapies. We based the processes on image analysis to define a predictive methodology in order to meet every patients' needs to its best. In short, CuraBone has focused on the development of a predictive computer-based platform for the creation of patient-fitted implants for cranio-maxillofacial (CMF) applications and knee and shoulder joints.
Thanks to the current advances in image-based technologies, the patients' bone shape can be replicated with a 3D-model and even 3D-printed. Using imaging techniques like CT or MRI helps to visualize the actual inner structures of a patient. Well-fitted 3D-models of implants or scaffolds can be designed directly on the patients' actual surface of his/her broken bone. Although, it is not possible to predict the outcome of different treatments (bone ingrowth into the implant, healing and regeneration). In fact, surgeons, clinical engineers and industry should develop the implant together to ensure the best outcome.
CuraBone aimed to bridge the gap between research and Industry, focusing on three main orthopaedic applications: knee and shoulder joints and cranio-maxillofacial surgery and additionally evaluated different bioresorbable and non-resorbable scaffold solutions. To accomplish this aim, CuraBone has comprised three objectives. First, musculoskeletal patient-specific models were created. These models used individual patient data like bone geometries or muscle attachment locations to calculate the loads acting on the bone-implant-composition. Second, a computational-based platform was developed to simulate the impact of therapeutic treatment, optimizing the design of implants and providing personalized rehabilitation therapies. Finally, a systematic methodology was implemented to validate the developed computational models. A quantitative comparison between clinical and numerical results was conducted resulting in accurate personalized predictive models for each situation.
The three objectives were successfully achieved during CuraBone development. Using computer simulation technologies CuraBone has achieved optimized, patient-specific treatments of bone injuries and rehabilitation therapies. We based the processes on image analysis to define a predictive methodology in order to meet every patients' needs to its best. In short, CuraBone has focused on the development of a predictive computer-based platform for the creation of patient-fitted implants for cranio-maxillofacial (CMF) applications and knee and shoulder joints.
CuraBone main results are presented according to the application field and the technologies used. Hence, one of the main orthopaedic applications are joints. Human joints carry a lot of loads and help to buffer many daily impacts during our lifetime. Therefore, they normally suffer damage and degeneration. Elderly patients often experience problems with degenerations of the cartilage, ligaments, meniscus or even the bones. If all these factors occur in the same patient, a total joint arthroplasty might be necessary. A methodology has been created in order to develop personalized musculoskeletal models of the joints: Maria Paz Quilez and David Leandro Dejtiar for the knee (Fig.1); Maria Hilvert and Antoine Vautrin for the mandible and Jonathan Pitocchi for the shoulder. This process has allowed an assessment of the functional outcome after implantation according to patient satisfaction.
To achieve a successful total joint arthroplasty, implants have to be mechanically fixated to the bone, its stability is highly dependent on the interaction between the implant and bone tissue. The long-term fixation of a porous implant is mainly regulated by the relative micro-motion between prosthesis and host bone. Therefore, Jonathan Pitocchi developed a method for automatically generating a finite element model (FEM) of a shoulder implant, which predicts the micro-motion for a custom reverse shoulder implant (Fig.2) [1]. The methodology also incorporates a novel tool that combines scapular bone shape and cortical morphology in a statistical shape model [2]. In addition, a musculoskeletal model was created by means of an automated method for accurately measuring muscle elongations during the preoperative planning of shoulder arthroplasty [3]. This numerical platform can be easily adapted to analyze different bones and prostheses in the future. It may have important applications in the design and planning of custom implants, calculating the results and guaranteeing low computational costs.
Reverse shoulder implants have a 3D-printed customized glenoid component where bone ingrowth is fundamental for the long-term success of the fixation. Gabriele Nasello developed a mechano-driven algorithm implemented in a FEM based approach which was validated using goat in-vivo experiments [4]. This predictive tool will guide future bone regeneration after surgical interventions [5]. Validation of bone regeneration algorithms was achieved through the creation of novel microfluidic-based in-vitro cell cultures where Gabriele Nasello recreated bone formation under controlled conditions [6,7] (Fig.3).
In addition, Antoine Vautrin and Maria Hilvert developed a computer-based methodology for the personalized design of bioresorbable implants for cranio-maxillofacial applications (Fig.4) [8]. Currently, preoperative planning is already used to supply the surgeon with patient-specific plates (non-resorbable). To develop bioresorbable solutions for this application, different materials have been evaluated for the different applications. CMF plates have been computationally evaluated, considering plate degradation and bone healing process.
Finally, one of the main challenges of these bioreasorbable plates was to characterize the dynamics of material degradation under different conditions. Therefore, Simone Russo has designed and fabricated a new bioreactor that provides the possibility to apply different fluid flow conditions and that has been conceived to evaluate material degradation over time (Fig.5).
To achieve a successful total joint arthroplasty, implants have to be mechanically fixated to the bone, its stability is highly dependent on the interaction between the implant and bone tissue. The long-term fixation of a porous implant is mainly regulated by the relative micro-motion between prosthesis and host bone. Therefore, Jonathan Pitocchi developed a method for automatically generating a finite element model (FEM) of a shoulder implant, which predicts the micro-motion for a custom reverse shoulder implant (Fig.2) [1]. The methodology also incorporates a novel tool that combines scapular bone shape and cortical morphology in a statistical shape model [2]. In addition, a musculoskeletal model was created by means of an automated method for accurately measuring muscle elongations during the preoperative planning of shoulder arthroplasty [3]. This numerical platform can be easily adapted to analyze different bones and prostheses in the future. It may have important applications in the design and planning of custom implants, calculating the results and guaranteeing low computational costs.
Reverse shoulder implants have a 3D-printed customized glenoid component where bone ingrowth is fundamental for the long-term success of the fixation. Gabriele Nasello developed a mechano-driven algorithm implemented in a FEM based approach which was validated using goat in-vivo experiments [4]. This predictive tool will guide future bone regeneration after surgical interventions [5]. Validation of bone regeneration algorithms was achieved through the creation of novel microfluidic-based in-vitro cell cultures where Gabriele Nasello recreated bone formation under controlled conditions [6,7] (Fig.3).
In addition, Antoine Vautrin and Maria Hilvert developed a computer-based methodology for the personalized design of bioresorbable implants for cranio-maxillofacial applications (Fig.4) [8]. Currently, preoperative planning is already used to supply the surgeon with patient-specific plates (non-resorbable). To develop bioresorbable solutions for this application, different materials have been evaluated for the different applications. CMF plates have been computationally evaluated, considering plate degradation and bone healing process.
Finally, one of the main challenges of these bioreasorbable plates was to characterize the dynamics of material degradation under different conditions. Therefore, Simone Russo has designed and fabricated a new bioreactor that provides the possibility to apply different fluid flow conditions and that has been conceived to evaluate material degradation over time (Fig.5).
CuraBone has meant an important progress beyond the current state of the art. Different multiscale computational tools were created for pre-operative planning which were focused on patient-specific orthopaedic implants (knee, shoulder and cranio-maxillofacial). A precise personalize pre-operative planning reduces complication rates after surgery, increases patient satisfaction and posterior long-term performance. These facts are directly related with a good socio economic impact and improves the welfare state.
Additionally, CuraBone has created a new generation of researchers able to manage new ideas, design, development, testing, validation and protection of new products and also able to be part of highly skilled research and professional teams. They have started very promising careers: Maria Paz Quilez is a partnership R&D Project manager in Biocartis (BE); Jonathan Pitocchi continues in Materialise (BE) as Shoulder Research Coordinator; Maria Hilvert is Innovation Manager in RWTH Innovation GmbH (DE); Gabriele Nasello got a post-doc position in KULeuven (BE); Simone Russo is Project Coordinator in Medpace (BE), David Leandro Dejtiar continues as a Research Engineer in Materialise and finally Antoine Vautrin has a research position in AO Foundation (CH).
Additionally, CuraBone has created a new generation of researchers able to manage new ideas, design, development, testing, validation and protection of new products and also able to be part of highly skilled research and professional teams. They have started very promising careers: Maria Paz Quilez is a partnership R&D Project manager in Biocartis (BE); Jonathan Pitocchi continues in Materialise (BE) as Shoulder Research Coordinator; Maria Hilvert is Innovation Manager in RWTH Innovation GmbH (DE); Gabriele Nasello got a post-doc position in KULeuven (BE); Simone Russo is Project Coordinator in Medpace (BE), David Leandro Dejtiar continues as a Research Engineer in Materialise and finally Antoine Vautrin has a research position in AO Foundation (CH).