Periodic Reporting for period 2 - NU-SPINE (Training innovative future leaders in research and development of materials and implants for the spine)
Berichtszeitraum: 2021-01-01 bis 2023-09-30
The NU-SPINE network aimed to deliver a strong professional development programme, leading to scientists and engineers well trained in biomedical engineering, entrepreneurship and in cutting-edge spinal materials, implants and their evaluation methods.
This was prompted by the growing elderly and more active population, which puts higher demands on implants, which need to last longer and withstand more severe loading conditions. In the spine, mechanical resistance as well as biocompatibility are especially important due to the vicinity of sensitive tissues such as the spinal cord and nerves. NU-SPINE aimed to deliver novel material compositions with a higher degree of biocompatibility as well as novel implant designs adapted to the local loading situation. Important deliverables were also innovative methods for more accurate evaluation of the demanding tribological and corrosive conditions surrounding the implants.
Due to the multidisciplinarity of the projects, a network of higher education institutions and industrial partners with complementary skills were assembled to fulfil the project aims and objectives, under guidance from clinical advisors. The combination of the individual partners' expertise provided the ESRs with a multidisciplinary skill set and ensured successful delivery of the programme – indeed all deliverables were achieved. Acknowledging the importance of the whole value chain gave the ESRs an insight into the scientific requirements of novel medical devices, as well as a good starting point for preclinical testing at the end of the projects.
This was prompted by the growing elderly and more active population, which puts higher demands on implants, which need to last longer and withstand more severe loading conditions. In the spine, mechanical resistance as well as biocompatibility are especially important due to the vicinity of sensitive tissues such as the spinal cord and nerves. NU-SPINE aimed to deliver novel material compositions with a higher degree of biocompatibility as well as novel implant designs adapted to the local loading situation. Important deliverables were also innovative methods for more accurate evaluation of the demanding tribological and corrosive conditions surrounding the implants.
Due to the multidisciplinarity of the projects, a network of higher education institutions and industrial partners with complementary skills were assembled to fulfil the project aims and objectives, under guidance from clinical advisors. The combination of the individual partners' expertise provided the ESRs with a multidisciplinary skill set and ensured successful delivery of the programme – indeed all deliverables were achieved. Acknowledging the importance of the whole value chain gave the ESRs an insight into the scientific requirements of novel medical devices, as well as a good starting point for preclinical testing at the end of the projects.
An overview of the NUSPINE results and their exploitation and dissemination can be found below, WP by WP.
WP2: Synthesis of novel materials with enhanced biocompatibility
Fully biocompatible silicon nitride bulk materials as well as coatings were synthesized and characterized. Furthermore, material for an all-ceramic total disc replacement design was developed, as well as a more bioactive spinal fusion cage. The research was disseminated through 5 scientific papers and 8 conference contributions. Another 10 scientific papers are submitted or being prepared. The work has also led to 2 patent applications and 1 spin-off company. The ESRs attended more than 50 training courses and workshops.
1 PhD thesis was defended in 2023, the others are scheduled for 2024.
ESR1 is currently working for a start-up in the Spine Medical Device industry in Sweden. ESR 12 is working as a development engineer in the Med Tech field in Germany.
WP3: Structural design and advanced mechanical characterization of novel materials and implants for the spine
Several new spinal implant designs were developed and validated through mechanical testing, namely optimized screws for trabecular bone, an all-ceramic total disc replacement, as well as two new spinal fusion cage designs. The research was disseminated through 17 papers, 6 open data sets and 20 conference contributions. 2 patent applications were submitted. The ESRs in WP3 attended approx. 20 training activities (courses and workshops).
3 PhD defences are scheduled in winter 23/24, 2 in spring 24. The work by ESR2 also led to 2 granted funding applications to the Swedish Innovation Agency, allowing him to continue the work after defending.
WP4: Tribology and corrosion of novel materials and implants for the spine
New testing protocols for the adverse tribological and tribocorrosive assessment of spinal devices were developed. Furthermore, an advanced control system for use in tribocorrosion simulators was developed, as well as a new facet joint prosthesis design. The research was disseminated in 2 scientific papers and 10 conference contributions. 2 manuscripts in preparation. This WP suffered more severe COVID-related delays due to higher societal restrictions. ESRs in WP4 attended more than 45 training activities.
PhD defences are scheduled in spring 2024.
Industry impact was mainly achieved by ESR8. Here, algorithms for the control system have been employed in commercial apparatus or applications through Key Engineering Solutions.
ESR6 is currently employed as a researcher in the UKRI Programme Grant Oncological Engineering whilst ESR 8 is working as a System Test Engineer at ASMPT SMT UK Limited.
WP5: Biological response to materials
The biological response to the developed materials was evaluated, including developing better methods to this end. A comprehensive in vitro comparison of cellular effects on various biomaterials for spinal implants was carried out. Furthermore, newly developed materials were evaluated in vitro as well as in vivo. A 3-dimensional model for bridging the gap between 2D in vitro and in vivo biological evaluations was also developed and applied to silicon nitride coating material and debris. The research was disseminated through 8 scientific papers and 16 conference contributions. 2 papers are in preparation. About 25 training activities were attended by ESRs in WP5.
One PhD thesis has been defended, the other is scheduled in spring 2024.
The work of ESR5 serves as the basis for current bridge funding applications aimed at entrepreneurship-focused post-doctoral training. ESR5 currently pursues a postdoc at ETHZ.
WP2: Synthesis of novel materials with enhanced biocompatibility
Fully biocompatible silicon nitride bulk materials as well as coatings were synthesized and characterized. Furthermore, material for an all-ceramic total disc replacement design was developed, as well as a more bioactive spinal fusion cage. The research was disseminated through 5 scientific papers and 8 conference contributions. Another 10 scientific papers are submitted or being prepared. The work has also led to 2 patent applications and 1 spin-off company. The ESRs attended more than 50 training courses and workshops.
1 PhD thesis was defended in 2023, the others are scheduled for 2024.
ESR1 is currently working for a start-up in the Spine Medical Device industry in Sweden. ESR 12 is working as a development engineer in the Med Tech field in Germany.
WP3: Structural design and advanced mechanical characterization of novel materials and implants for the spine
Several new spinal implant designs were developed and validated through mechanical testing, namely optimized screws for trabecular bone, an all-ceramic total disc replacement, as well as two new spinal fusion cage designs. The research was disseminated through 17 papers, 6 open data sets and 20 conference contributions. 2 patent applications were submitted. The ESRs in WP3 attended approx. 20 training activities (courses and workshops).
3 PhD defences are scheduled in winter 23/24, 2 in spring 24. The work by ESR2 also led to 2 granted funding applications to the Swedish Innovation Agency, allowing him to continue the work after defending.
WP4: Tribology and corrosion of novel materials and implants for the spine
New testing protocols for the adverse tribological and tribocorrosive assessment of spinal devices were developed. Furthermore, an advanced control system for use in tribocorrosion simulators was developed, as well as a new facet joint prosthesis design. The research was disseminated in 2 scientific papers and 10 conference contributions. 2 manuscripts in preparation. This WP suffered more severe COVID-related delays due to higher societal restrictions. ESRs in WP4 attended more than 45 training activities.
PhD defences are scheduled in spring 2024.
Industry impact was mainly achieved by ESR8. Here, algorithms for the control system have been employed in commercial apparatus or applications through Key Engineering Solutions.
ESR6 is currently employed as a researcher in the UKRI Programme Grant Oncological Engineering whilst ESR 8 is working as a System Test Engineer at ASMPT SMT UK Limited.
WP5: Biological response to materials
The biological response to the developed materials was evaluated, including developing better methods to this end. A comprehensive in vitro comparison of cellular effects on various biomaterials for spinal implants was carried out. Furthermore, newly developed materials were evaluated in vitro as well as in vivo. A 3-dimensional model for bridging the gap between 2D in vitro and in vivo biological evaluations was also developed and applied to silicon nitride coating material and debris. The research was disseminated through 8 scientific papers and 16 conference contributions. 2 papers are in preparation. About 25 training activities were attended by ESRs in WP5.
One PhD thesis has been defended, the other is scheduled in spring 2024.
The work of ESR5 serves as the basis for current bridge funding applications aimed at entrepreneurship-focused post-doctoral training. ESR5 currently pursues a postdoc at ETHZ.
Progress beyond state of the art per ESR:
1: development of silicon nitride technical ceramics of higher bioactivity, antiviral and antibacterial activity
2: design of the first ready-to-use spinal fusion titanium implant maximizing a core of osteoinductive ceramic
3: design of novel ceramic coatings for spinal implants through combinatorial methods
4: first application of topology optimization in large-scale simulation models
5: development of advanced in vitro models of osseointegration, including effects of dynamic loading and an inflammatory environment
6: adaptation of advanced spine wear simulators to account for adverse loads in the cervical spine
7: development of new facet joint implants for the lumbar region
8: development of a control system for spinal simulators with improved accuracy for large changes in load
9: development of novel ceramic coatings using CVD methods, scaled up for facet joint implants
10: structural optimization to develop an all-ceramic total disc replacement
11: development of new screw design constructs, better adapted to the surrounding bone
12: manufacturing and upscaling of a functional all-ceramic total disc replacement
13: development of methods for dynamic loading of spinal implants for proof-testing
14: elucidation of mechanisms of fretting-crevice corrosion of spinal instrumentation systems
15: more advanced and realistic in vitro models for assessment of biocompatibility in the spinal environment
Besides the dissemination activities outlined previously, the research was communicated through 19 occasions of public engagement activities and 40 LinkedIn Posts.
The research and training program led to several new materials and implant designs for the spine, as well as 15 trained research leaders of the future. This is expected to provide great value to the society at large in the long-term, as indicated by the wealth of developed new knowledge in the field, patent applications that can lead to commercial products of direct benefit to patients, and the success of the ESRs so far in securing good positions in academia and industry.
1: development of silicon nitride technical ceramics of higher bioactivity, antiviral and antibacterial activity
2: design of the first ready-to-use spinal fusion titanium implant maximizing a core of osteoinductive ceramic
3: design of novel ceramic coatings for spinal implants through combinatorial methods
4: first application of topology optimization in large-scale simulation models
5: development of advanced in vitro models of osseointegration, including effects of dynamic loading and an inflammatory environment
6: adaptation of advanced spine wear simulators to account for adverse loads in the cervical spine
7: development of new facet joint implants for the lumbar region
8: development of a control system for spinal simulators with improved accuracy for large changes in load
9: development of novel ceramic coatings using CVD methods, scaled up for facet joint implants
10: structural optimization to develop an all-ceramic total disc replacement
11: development of new screw design constructs, better adapted to the surrounding bone
12: manufacturing and upscaling of a functional all-ceramic total disc replacement
13: development of methods for dynamic loading of spinal implants for proof-testing
14: elucidation of mechanisms of fretting-crevice corrosion of spinal instrumentation systems
15: more advanced and realistic in vitro models for assessment of biocompatibility in the spinal environment
Besides the dissemination activities outlined previously, the research was communicated through 19 occasions of public engagement activities and 40 LinkedIn Posts.
The research and training program led to several new materials and implant designs for the spine, as well as 15 trained research leaders of the future. This is expected to provide great value to the society at large in the long-term, as indicated by the wealth of developed new knowledge in the field, patent applications that can lead to commercial products of direct benefit to patients, and the success of the ESRs so far in securing good positions in academia and industry.