Bone Bricks: Cost effective modular osseointegrated prosthetics for large bone loss surgical procedures

The Syrian conflict has displaced around 3 million refugees into Turkey, accounting for around 4% of its population. Turkey provides free of charge healthcare services to Syrians and as such the burden on the healthcare system is significant with 940 thousand patients treated, 780 thousand operations and 20.2million outpatient services utilised. Recently, the Turkish government announced that it has spent over £9 billion in support of Syrians living in Turkey, including health insurance, since the beginning of the crisis, and a further £3.2 billion funding is still required from the Turkish economy.
This project will create Bone Bricks to assemble a customised patient specific prosthetic implant to treat large bone injuries. It proposes to build on the current treatment of external fixation but with the addition of an engineered internal prosthetic implant to improve patient outcomes, avoid painful limb lengthening and reduce recovery time. Each limb salvage requires a patient specific prosthetic to fill the bone lost from their injury. This is achieved by constructing the prosthetic implant from 3D printed modular pieces, "bone bricks". The bone bricks, made with biocompatible and biodegradable polymer-ceramic materials, will come in a pallet of shapes and sizes and fit together in a "lego like" way to form the prosthesis. The assembled prosthesis creates a hollow cage which is filled with an infection prevention paste. The prosthesis and paste will prevent infection, promote bone regeneration creating a mechanically stable bone union. This will enable limb salvage as an alternative to amputation, avoiding painful limb lengthening and improving recovery time/functional patient outcomes.
The Bone Bricks project utilises will engage patients, doctors, medical device manufacturers and researchers to develop a medical implant that will be used to enable injured Syrians to avoid amputation of their limbs after they have sustained injuries during the conflict (such as blast injuries). Although our primary focus is the displaced Syrian population living in Turkey a new treatment for large bone loss would benefit Turkish and UK citizens injured in accidents e.g. falls or road traffic accidents. Furthermore, our novel low cost solution would benefit people from the current 40 active conflicts displacing more than 13 million people in other Official Development Assistance (ODA) countries.

The project will create a new medical device ready to be implemented in human clinical trials. Direct patient benefit could be implemented in a follow on project for a small number of patients with wider impacts spread if the trial is successful.
Preparation for commercialisation will take part in this project. A two part medical device evidence file will be produced to obtain regulatory approval in Turkey and evidence for future CE marking in the UK. Intellectual property (IP) created on the project will be managed jointly through the University of Manchester, University College of London, Manchester Royal Infirmary and Sabanci University commercial departments. They will help the consortium to create a pre IP and a predicted IP agreement. It is envisaged that IP will be licenced to the Turkish company Response Ortho at a minimal rate to ensure technology transfer and benefit to Syrian refugees and the Turkish economy. Response Ortho is a fast growing company engaged in the development, manufacture and marketing of innovative solutions of advanced fixation and bone deformity correction devices. The company is dedicated to bringing new technologies, innovative systems in a cost effective manner operating worldwide. Any revenue generated from the IP will be used either to further develop the prosthetic implant or to develop similar medical devices for other emerging countries, guaranteeing to sustain this research collaboration.
The project would help create a hub for medical devices at Sabanci University which would enhance its reputation and attract students and further industrial investment. In addition the project success would translate to reduced lifetime healthcare costs for Syrian refugees injured by the conflict by enabling limb salvage and integration into Turkish society.
Although our primary focus is the displaced Syrian population living in Turkey a new treatment for large bone loss would benefit people from Turkey, the UK and worldwide injured in accidents e.g. falls, road traffic accidents. In UK, approximately 2000 patients per year receive treatment for severe fractures requiring surgical reconstruction for bone loss. There is a burden on the health service of major traumatic injuries, which is estimated to be in excess of £0.5 billion. In addition, the estimated loss of contribution to the economy due to extended periods of rehabilitation is an estimated £3.5 billion.
The novelty of the project involves translating and extending cutting edge tissue engineering and biomanufacturing techniques to advance healthcare treatment methods. The project will publish the research in high impact international journals to disseminate the knowledge from the project to the academic community. Engagement with charities and clinicians on the project will provide further impact pathways for this new technology to gain acceptance and inspire other healthcare solutions.
The project involves collaboration between early career and experienced professionals. This will provide training and experience for the early stage career academics, the PDRAs and the PhD student that will enable them to make a long lasting contribution to innovative medical device development throughout their career.