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Development of load-bearing fibre reinforced composite based non-metallic biomimetic bone implant

Final Report Summary - NEWBONE (Development of load-bearing fibre reinforced composite based non-metallic biomimetic bone implant)

The major aim of NEWBONE project was to develop Fibre and Nanohybrid reinforced composite (FRC and NHRC) material for surgical bone repair and replacement where load-bearing and ligament fixation capabilities are essential. NEWBONE project has developed FRC and NHRC material for surgical bone repair and replacement where load-bearing and ligament fixation capabilities are essential. NEWBONE implants will be used to treat serious bone trauma and other defects with a great importance in orthopaedics and traumatology. The exploitation of project results on NHCR material research a resorbable fixation implants for knee and shoulder ligament repair lead to preclinical tests of the prototypes. ConMed commercialised the ACL interference screw line based on NHRC material developed in the NEWBONE project. This product line includes the world's smallest composite ACL interference screw. The new implant has many new benefits in comparison to the implants at the current market. Because of the miniature size less damage to healthy tissue is caused by the surgery. The new material has been demonstrated to promote bone growth and the attachment of the implant to the surrounding tissues.

Healing and recovery of a patient is faster and more thorough because of the biodegradable implant does not need to be surgically removes and the new implant properties speeds up ossification by binding the tendon and bone solidly together. With this less invasive and biodegradable implant the natural healing of the damaged site is faster and more thorough than ever before. Biodegradable screws and anchors are now used in, for example, the treatment of sports injuries. Our biodegradable screws of biocomposite material technology produces unique results,' says Kaj Koskinen, the managing director of ConMed Linvatec Biomaterials Ltd. The project will increase the turnover of the European implant industry and improve competitiveness in the health product market,' says ConMed's Kimmo Lähteenkorva. 'Because of the new technology, the European implant industry has become the market leader in the area of biodegradable composite implants,' adds Koskinen. 'We believe that the new biodegradable and bioactively healing implants will significantly improve health care worldwide,' says Professor Pekka Vallittu from the University of Turku. The new implant fills the gap at the sport medicine implant market, enjoys Esa Suokas, NEWBONE project leader of ConMed.

In FRC material development work, the FRC-plate was selected for further prototype development for the preclinical experiments and for the development into a commercial product. The preclinical test results confirmed the relevance of FRC implants as load-bearing implants. The results showed that when a bioactive surface is used with FRC implants it should combine surface micro-roughness with bioactive properties. From the group of materials tested, the FRC-surface with the hydroxyapatite with 100-300 µm granule size is the preferable surface design. The preclinical tests carried out by the project gave a support to the conclusion that FRC-plate has a great commercial potential. However, the short term products are FRC intramedullary nails and compression screws with a new fixation system other than screws which need to be developed. In the medium term this requires still work to be done. One of the conclusions is that the long term products are FRC spinal implants and nail/plates with bioactive surface for fast bone growth and / or anti-infective. The properties of FRC implants enable use and diagnostics by Magnetic resonance imaging (MRI) and three-dimensional (3D) cone beam X-ray imaging systems and Computed tomography (CT).

We expect partners to be committed in using the results in further development of commercial products based on FRC and NHRC technologies. We also expect further scientific cooperation with the partners in writing scientific public publications and in future research work.

The project was high-tech SME driven. Ten Small and medium-sized enterprises (SMEs) involved represent different competence areas needed to develop the FRC and NHRC bone implant. Six research institution partners were adding to this competence portfolio and the latest knowledge developed by them was transferred to the use of the SMEs. The consortium gathers together various actors needed around Europe and from different sectors such that it is possible to proceed to preproduction level in the area of FRC implants. The coordination and management was effectively carried out in a great cooperation between coordinator, co-coordinator and manager and technical coordinator ensuring that all contractual issues were taken care of and the project work by the consortium went smoothly.

There were four major breakthrough innovations associated in the project:
(1) new FRC thermoset material used for load-bearing bone implants;
(2) bioactive glass and hydroxyapatite are used in FRC composites with bioactive and resorbable biopolymers on the implant-bone interface;
(3) a new processing method was applied to produce surface porous bioactive FRC composite material for implants; and
(4) new nanohybrid (NHRC) material based on calcium phosphate additive and resorbable polymer matrix composite used for ligament fixation in knee / shoulder indications.

The results of the project NEWBONE are expected cover the gaps that exist in Europe in terms of increased health care costs and decreased quality of life of the patients involved in bone replacement operations as well as in terms of Europe dragging behind United States in the commercialisation of biomaterials and implant technologies. Surgical procedures involving bone and joint replacements are increasing in a linear fashion especially in Europe due to aging population. Also the average age of the users of implants is decreasing and thus the load-bearing requirements for implants are getting tougher. In the medical sector, biomaterials is one of the fastest growing sectors reflecting the continuously increased demand for joint replacements and spinal surgery and the exponential increase of osteoporotic fractures. Currently, the Unites States is the world market leader in the field. Many of the implant and biomaterials technologies have been invented in Europe but the commercialisation has been lost to outside Europe.

The partners in this project consortium included the Swiss SME Medacta, a producer and marketer of hip and knee prosthesis and the Finnish company ConMed Linvatec Biomaterials Ltd, part of a global medical sector company and a producer and marketer of sports injury repair systems. Medacta is committed to develop FRC load bearing bone implants. ConMed is committed to develop sports medicine implants from the NHRC composite material developed in the project. In the end of 2009, ConMed commercialised the ACL interference screw line based on NHRC material developed in the NEWBONE project. This product line includes the world's smallest composite ACL interference screw, namely 5.0 mm. Both Medacta and ConMed are committed to the further development of the FRC and NHRC material based implants to be included to their future product portfolios. With their existing marketing organisations having a good global coverage, the project results have immediate potential to be commercialised worldwide. Together with all the industrial partners involved, a consortium is formed that have the abilities to increase the turnover of European implant industry and take the role of a global leader in the sector of FRC load-bearing bone implants and of NHRC based sports medicine implants.