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SPINe: Numerical and Experimental Repair strategies

Periodic Reporting for period 1 - SPINNER (SPINe: Numerical and Experimental Repair strategies)

Reporting period: 2018-01-01 to 2019-12-31

Back pain is an extremely common problem with more limited solutions than limb joints. Together with other musculoskeletal disorders back pain creates a long term financial burden both due to both the costs to health services and social care and the loss of income; 60% of people on early retirement or long term sick leave state that musculoskeletal problems are the reason*. Back pain is an extremely common problem with more limited solutions than limb joints. The number of patients requiring complex spine surgery is rapidly expanding, and the biomedical engineering industry needs suitably trained innovators to produce economic solutions to support healthy ageing for the people of Europe.

SPINNER is a doctoral training programme aimed at Bioengineering early stage researchers, to train bioengineers to be in a position to design the next generation of repair materials and techniques for spine surgery. SPINNER brings together partners from the biomaterials (Finceramica), implantable devices (Aesculap), and computational modelling (Ansys, Adagos) industries with orthopaedic clinicians (National Centre for Spinal Disorders, NCSD) and academic experts in cell, tissue and organ scale biomaterials and medical device testing (Universities of Sheffield and Bologna).

Key SPINNER objectives are:
1) Training of orthopaedic Bioengineers capable of integrating in vitro, ex vivo and in silico data across scales for a holistic approach to spine reconstruction.
2) Development of bioactive, bioresorbable, mechanically competent materials for restoration of the vertebral bone and stable fusion.
3) Mechanical characterisation of implant materials and reconstructed spines in vitro and in silico.
4) Integrated, user-friendly, in silico models of the mechanics of damaged and reconstructed spinal segments that can be used for predictive design, patient specific analysis and surgical navigation.

* European Action towards better musculoskeletal health. Published by The Bone & Joint Decade Department of Orthopedics, University Hospital. SE-221 85 LUND, Sweden.
Six early stage researchers (ESRs) have been recruited and enrolled on PhD programmes to to work on the following research projects:

ESR1: Osteoinductive injectable/ mouldable bone graft substitute for spine repair
Development of multisubstituted hydroxyapatite (SrMgHA) to manufacture orthopaedic cements and putties for enhanced bone regeneration in spinal fusion.
Hosted by the University of Sheffield, UK, with industrial secondment to Finceramica, Italy.

ESR2: Development of osteoinductive coatings for spinal implants (fusion cages)
To develop an osteoinductive coating for cages used in spinal fusion, through exploring the antibacterial properties of multisubstituted apatite.
Hosted by the University of Sheffield, UK, with industrial secondment to Finceramica, Italy.

ESR3: Integration of clinical experience and in vitro biomechanical testing to improve spinal augmentation
To develop understanding of the failure mechanism of augmented spine segments, focusing both on the kinematics, and on the load transfer.
Hosted by the University of Bologna, Italy, with clinical secondment to National Center for Spinal Disorders, Hungary.

ESR4: Sagittal stability: movement analysis before and patient motion after spinal treatments
To develop a comprehensive approach to spinal balance and more in general to spine biomechanics.
Hosted by the University of Bologna, Italy with clinical secondment to National Center for Spinal Disorders, Hungary.

ESR5: Modelling spinal surgical procedures
Development of a personalised finite element model of the lumbar spine to simulate spinal repair systems.
Hosted by Ansys, France, with academic supervision from the University of Sheffield, UK.

ESR6: Statistical shape modelling and reduced order modelling techniques for patient-specific models
The goal is to design a procedure that creates a patient specific in silico model of the spine. This model shall evolve and adapt depending on the real time action of the clinician during the clinical procedure.
Hosted by Adagos, France, with academic supervision from the University of Sheffield, UK.

ESR1 and ESR2 have spent significant time on their secondments to industry at Finceramica, Italy and ESR4 at the clinic at the National Center for Spinal Disorders, Hungary.

The Spinner Fellows have attended two training events:

Training Event 1: Hosted by Aesculap AG, Tuttlingen, Germany
The Spinner Fellows learnt about Aesculap's spine surgery equipment and associated research and development. They had the opportunity to practice spine surgery techniques using authentic tools and implants on model spines, in a training suite for spine surgeons. Spine surgeons from Czechia and Hungary provided detailed insight into the procedures and challenges of different types of spine surgery for a variety of conditions. This training provided detailed contextualisation for the research projects that they are engaged on.

Training Event 2: Hosted by the University of Bologna, and Finceramica, Italy
This training event opened with the Spinner Fellows observing spine surgery at the Istituto Ortopedico Rizzoli. This was followed by workshops on academic writing and publishing, intellectual property, research ethics and a tour of the Biomechanics Laboratory at the University of Bologna. The Fellows learnt about project management from three different industrial perspectives: a large software house, a startup software company and in the development of an implantable device. Finceramica a biomaterials company that synthesises materials for bone and joint repair, provided an insight into their products and materials and the development of implantable products.

These Training Events have provide the Spinner Fellows with the background, knowledge, insight and skills to engage with their PhD research projects.

All the ESRs have passed their first year vivas and have progressed onto their second year of their PhDs.
Biomaterials
Prototypes of powders and paste bone graft with biological enhanced properties have been produced.
Prototypes of materials designed to enhance bone growth for the coating spinal fusion cages have been developed.
These materials in the future could provide improved materials to be used in spine surgery, enhancing the patients’ prognosis.

Biomechanics
Methods to measure to quantify the mechanical competence of natural, diseased and treated vertebrae have been developed.
A protocol for the measurement of spinal movement of healthy, diseased and treated patients, using motions capture techniques have been developed and employed to capture measurements healthy volunteers and spine patients before and after surgery.
This work will provide insights into the effects of spine disease and its treatment on the biomechanics of the spine.

In silico modelling
Computer models of the spine and its treatment with fixtures, such a screws and rods has been to assess the effects of the screw parameters and placement of virtual surgery on the spine.
A statistical shape modelling method is being developed to fit a generic model of a spine to patient specific data take from clinical images, to allow the efficient development of a personalised computer spine model.
This work will assist spine surgeons in planning spine surgery, through the real-time evaluation of possible interventions.
Spinner Fellows watch telecast of live spine surgery at Istituto Ortopedico Rizzoli, Bologna, Italy.
The Spinner Fellows at their first training event host by Aesculap AG, Tuttlingen, Germany.
Spinner Fellows and Supervisors apply spinal fixations to cervical and lumbar spines, in Aesculap.