Objective
A longer lasting, cost reduced and better osteointegrable orthopaedic knee implant has been developed. The work performed on the application of high power laser surface processing methods has delivered a calcium phosphate coating that shows a graded interface layer between the Ti substrate and the coating consisting of calcium titanate, which provides a good bonding. At the outermost surface the coating composition is hydroxylapatite and its glassy phase. Such a well adhered bioactive coating should promote faster and better osteointegration of implants for bone substitution.
Various processing routes have been explored with two different high power lasers, namely the CO2 and the Nd:YAG laser. The most successful process has been the Nd:YAG laser surface cladding. A patent has already been granted.
A sol-gel process has been developed to produce CaP powder specially suited for laser processing. In compliance to ASTM designation it is a high purity material with crystallinity greater than 99 % and Ca/P ratio of 1.67.
Cost reduction of the implant has been obtained by the introduction of a simpler design and instrumentation together with the use of fully automated 3-dimensional CAD/CAM and Real-Virtual-Real Technologies to fully analytically model, simulate and automate the design and manufacturing of the prosthesis and its coating. Design of 4 sizes of all parts of the knee prosthesis has been completed, and a 15% reduction in the cost of the surgical instrumentation has been achieved.
The prototype of the automated machine was completed and commissioned at the laser-processing site. The CAD model of the design of the knee prosthesis has been added to the simulation display software in order that the part is articulated in reality on the positioning system by simply moving the virtual part displayed on the computer screen.
Clad coatings produced with both lasers underwent three rounds of in-vitro testing, resulting in significant less cytocompatibility & higher cytotoxicity of the CO2 laser produced samples with regard to the Nd:YAG laser clads and plasma sprayed coatings, or the bare titanium used as reference material. In the final complete round of in-vitro testing, it was corroborated that the optimised Nd:YAG clad samples perform statistically comparable to plasma sprayed material. These promising results, together with the good adhesion (>35 MPa) of the coating, and the existence of a fusion bond interlayer between the Ti alloy and the coating has encouraged to conduct in-vivo testing in a sheep model.
Nd:YAG laser clad, plasma sprayed and bare titanium cylindres have been implanted into sheep femur and tibia for 12 and 24 weeks. The bone area around the implants and the bone-implant distance have been measured using hystomorphometrical methods. Both parameters showed no statistically significant difference between the two coated materials, while bare titanium performed worse.
Feasibility of the industrial production of the Nd:YAG laser cladding process has been demonstrated by using the Real-Virtual-Real automation technology to coat the real knee implant prototypes developed within the project. It is expected that after an industrial scaling-up period of 12-24 months, this technology may be ready to initiate clinical trials.
A longer lasting, cost reduced and better osteointegrable orthopaedic knee implant will be developed. The application of high power laser surface processing methods will enable to produce calcium phosphate coatings with better adhesion and higher bioactivity performance in vitro and in vitro. The rapid thermal treatment inherent to these processing routes would remove surface defects and micro cracks typical of machined titanium surfaces. To assure the supply of the CaP precursors appropriate for laser processing, new powder and non-powdery methods will be investigated, using less expensive reactants and eventually eliminating the environmental impact of the standard plasma spray processing. In order to cut down production costs of knee prosthesis a new joint design will be developed, and 3 dimensional CAD/CAM and Real Virtual Real Technologies will be applied to fully analytically model simulate and automate the design and manufacturing of the prosthesis and its coating. Quality control and environmental impact assessment of all partner's activities will be implanted.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- natural sciences chemical sciences inorganic chemistry transition metals
- engineering and technology materials engineering coating and films
- medical and health sciences clinical medicine orthopaedics
- medical and health sciences medical biotechnology implants
- natural sciences physical sciences optics laser physics
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Coordinator
36200 VIGO
Spain
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