Research into technological innovation in production processes and materials enables us to offer avant-garde devices that represent the gold standard in various fields of application. All the materials used comply with the relevant international standards.
Two types of coating are used, depending on the intended purpose of the device. One category includes coatings to apply to non-cemented devices whose main purpose is osteointegration, to guarantee an implant of excellent secondary stability. Porous titanium and hydroxylapatite coatings fall in this category. The other type of coating is of an non-allergenic nature (TiNbN) designed to isolate metal components and thereby minimize the release of metal ions into periprosthetic tissue.
Alongside coatings, there are certain surface treatments, such as anodising, applied to titanium alloy osteosynthesis devices to improve their surface properties and resistance to fatigue.
Plasma Spray Ti-Growth-C® coating
Ti-Growth-C ® is a porous titanium coating applied to a prosthesis using thermal spray technology. The Ti-Growth-C ® coating is characterized by large pores open and interconnected within a titanium matrix. This enables bone in-growth to take place within the pores, thus stabilizing the system in the long term. The degree of porosity (40-70%), the dimensions of the pores and interconnection channels (between 100 and 800 micron) set Ti-Growth-C ® apart from conventional plasma spray coatings, making it the ideal solution for non-cemented implants.
Titanium niobium nitride non-allergenic coating
There has been a growing scientific focus in recent years on the management of patients sensitive to metal ions. The percentage of the population allergic to ions like nickel or, more rarely, cobalt and chrome is growing constantly in fact. For this type of patient, a conventional metal prosthesis is not an optimal solution in that, under load, the forces acting on the interfaces may cause the release of ions into the periprosthetic tissues. Such release may trigger an immune reaction with local or systemic consequences that may cause not only the failure of the implant but serious anaphylactic reactions. The titanium niobium nitride coating was developed to provide the best solution for such patients. It is a ceramic coating completely bio-compatible, non-cytotoxic and non-genotoxic. It is applied to metal components to reduce the occurrence of allergic reactions. Thanks to PVD (physical vapor deposition) technology, the coating isolates the metal substrate with a barrier against allergenic ions. The exceptional reproducibility of this additive process enables coatings of constantly high quality to be produced. The coating is firmly anchored to the surface of the implant in a number of atomic layers. It should be noted that the TiNbN coating only modifies the properties of the implant’s surface and not the substrate’s properties or the biomechanical functionality of the implant itself. Further, recent studies have shown that coefficients of wear are low, making the coating suitable for applications with significantly large metal surfaces sliding against one another, as in knee endoprostheses.
BIOLOX® Delta heads and inserts
BIOLOX® Delta is the new material from the BIOLOX® family. Since it came onto the market, 1.6 million BIOLOX ® Delta heads and over 700,000 inserts have been implanted worldwide. It is a mixed oxide ceramic with a high resistance to fracture, excellent fracture toughness, optimum wear properties and total biocompatibility. These excellent properties are the result of two reinforcement technologies: the first involves the introduction of tetragonal nano-particles of zirconium oxide stabilized in the material. These particles are uniformly distributed in the aluminium matrix and during the transformation from the tetragonal to the monocline phase they absorb crack propagation energy, thereby reinforcing the material. The other reinforcement technology is based on the formation of elongated crystal plates in the oxide mix during sinterization. The plates prevent the formation and propagation of cracks by diverting their trajectory and reducing their energy, thereby increasing the material’s strength and hardness.
Type II anodizing (DOTIZE®)
Titanium alloys are characterized by an oxidized surface layer. The DOTIZE® anodizing process replaces this film of oxide with a thicker layer of oxide capable of improving certain important surface properties. Anodizing is a non-spontaneous electrochemical process in which an electrical current is generated across the surface of the implant, which is immersed in an electrolytic bath containing an alkaline solution. The current dissolves the surface of the implant and the layer of oxide becomes an integral part of the base material.
Type II anodizing increases fatigue resistance by up to 15%, improves resistance to abrasion and corrosion and increases surface hardness.
Anodizing also causes a reduction of up to 19% in protein absorption during the post-operative process of interaction between blood and the surface of the implant, thus reducing adhesion of osteoblasts and bone growth around the implant and facilitating the nail extraction phase.
OSPROVIT ® HA coating
Non-cemented prostheses need coatings that favour bone on-growth to ensure excellent secondary stability of the implant. One of these coatings is hydroxylapatite (Ca10[PO4]6[OH]2), a material already present in the human organism, where it is the main mineral constituent of bone. This coating is osteoconductive in that it plays a fundamental role in shaping bone growth, thus favouring osteointegration. Some studies, in fact, show bone growth of 1mm in the gap between implant and bone (Dumbleton et al. 2004) without fibrous tissue in between (Hardy et al. 1999 ) in the presence of hydroxylapatite. Hydroxylaptatite’s long history bears out the material’s high performance. Further, hydroxylapatite does not generate inflammation or allergic reactions and does not have any toxic or carcinogenic potential. By keeping the bone tissue alive, hydroxylapatite also brings about the remodelling that can be seen over the years and higher resistance to infection (Vidalain et al. 1999). The hydroxylapatite coating used is Osprovit® and has over 25 years of clinical story. It is plasma sprayed on non-cemented components. Now a well known and widely used process, plasma spraying is the high-velocity projection of particles melted into a gaseous stream against the device to be coated (Dumbleton et al., 2004).
TiSPS + Osprovit® HA hybrid coatings
Thanks to its low level of oxidation, a titanium SPS coating shows higher cohesive and adhesive strength than coatings applied with conventional air plasma spray processes.
Given its superior mechanical performance characteristics, Ti SPS is particularly suitable for making a rough titanium surface enabling bone on-growth to create stable osteintegration between bone and implant.
A second coating of Osprovit® hydroxylapatite may be deposited on top of a TiSPS coating to further stimulate a biological response.
Personalized resection blocks
Applied to the K-MOD knee replacement system, PERFETTO technology makes it possible to provide personalized 3D pre-operative planning for all patients.
The resection blocks are designed and made on the basis of magnetic resonance imaging or CTA. Interactive personalized 3D design guarantees a less invasive surgical procedure. PERFETTO technology also delivers greater precision of alignment and positioning and reduces both time in hospital and wear.