“…For many decades surgical reconstruction plates, nails and screws on the basis of steel and titanium alloys are used for reconstruction of bone defects in orthopedics, trauma-, hand-, craniofacial surgery [1,2]. Both share advantages and disadvantages.…”
Optimal treatment of bone fractures with minimal complications requires implant alloys that combine high strength with high ductility. Today, TiAl6V4 titanium and 316L steel are the most applied alloys in bone surgery, whereas both share advantages and disadvantages. The nickel-free, high-nitrogen austenitic steel X13CrMnMoN18-14-3 (1.4452, brand name: P2000) exhibits high strength in combination with superior ductility. In order to compare suitable alloys for bone implants, we investigated titanium, 316L steel, CoCrMo and P2000 for their biocompatibility and hemocompatibility (according to DIN ISO 10993–5 and 10993–4), cell metabolism, mineralization of osteoblasts, electrochemical and mechanical properties. P2000 exhibited good biocompatibility of fibroblasts and osteoblasts without impairment in vitality or changing of cell morphology. Furthermore, investigation of the osteoblasts function by ALP activity and protein levels of the key transcription factor RUNX2 revealed 2x increased ALP activity and more than 4x increased RUNX2 protein levels for P2000 compared to titanium or 316 steel, respectively. Additionally, analyses of osteoblast biomineralization by Alizarin Red S staining exhibited more than 6x increased significant mineralization of osteoblasts grown on P2000 as compared to titanium. Further, P2000 showed no hemolytic effect and no significant influence on hemocompatibility. Nanoindentation hardness tests of Titanium and 316L specimens exposed an indentation hardness (HIT) of about 4 GPa, whereas CoCrMo and P2000 revealed HIT of 7.5 and 5.6 GPa, respectively. Moreover, an improved corrosion resistance of P2000 compared to 316L steel was observed. In summary, we could demonstrate that the nickel-free high-nitrogen steel P2000 appears to be a promising alternative candidate for applications in bone surgery. As to nearly all aspects like biocompatibility and hemocompatibility, cell metabolism, mineralization of osteoblasts and mechanical properties, P2000 was similar to or revealed advantages against titanium, 316L or CoCrMo.
“…For many decades surgical reconstruction plates, nails and screws on the basis of steel and titanium alloys are used for reconstruction of bone defects in orthopedics, trauma-, hand-, craniofacial surgery [1,2]. Both share advantages and disadvantages.…”
Optimal treatment of bone fractures with minimal complications requires implant alloys that combine high strength with high ductility. Today, TiAl6V4 titanium and 316L steel are the most applied alloys in bone surgery, whereas both share advantages and disadvantages. The nickel-free, high-nitrogen austenitic steel X13CrMnMoN18-14-3 (1.4452, brand name: P2000) exhibits high strength in combination with superior ductility. In order to compare suitable alloys for bone implants, we investigated titanium, 316L steel, CoCrMo and P2000 for their biocompatibility and hemocompatibility (according to DIN ISO 10993–5 and 10993–4), cell metabolism, mineralization of osteoblasts, electrochemical and mechanical properties. P2000 exhibited good biocompatibility of fibroblasts and osteoblasts without impairment in vitality or changing of cell morphology. Furthermore, investigation of the osteoblasts function by ALP activity and protein levels of the key transcription factor RUNX2 revealed 2x increased ALP activity and more than 4x increased RUNX2 protein levels for P2000 compared to titanium or 316 steel, respectively. Additionally, analyses of osteoblast biomineralization by Alizarin Red S staining exhibited more than 6x increased significant mineralization of osteoblasts grown on P2000 as compared to titanium. Further, P2000 showed no hemolytic effect and no significant influence on hemocompatibility. Nanoindentation hardness tests of Titanium and 316L specimens exposed an indentation hardness (HIT) of about 4 GPa, whereas CoCrMo and P2000 revealed HIT of 7.5 and 5.6 GPa, respectively. Moreover, an improved corrosion resistance of P2000 compared to 316L steel was observed. In summary, we could demonstrate that the nickel-free high-nitrogen steel P2000 appears to be a promising alternative candidate for applications in bone surgery. As to nearly all aspects like biocompatibility and hemocompatibility, cell metabolism, mineralization of osteoblasts and mechanical properties, P2000 was similar to or revealed advantages against titanium, 316L or CoCrMo.
“…Compared to 316L stainless steel and other alloys used before, Ti has very high biocompatibility and low corrosion rate, which has showed quite good long-term results with few controversies. In 1958, Swiss surgeon Maurice Müller and his team studied the process of bone healing and the influence of rigid fixation on fracture repair, which gave birth to the subsequent world's famous organisation, the Association for the Study of Internal Fixation [41], [42]. In 1965, Müller et al.…”
Section: Research and Development History Of Orthopaedic Plates And Smentioning
Orthopaedic implants are applied daily in our orthopaedic clinics for treatment of musculoskeletal injuries, especially for bone fracture fixation. To realise the multiple functions of orthopaedic implants, hybrid system that contains several different materials or parts have also been designed for application, such as prosthesis for total hip arthroplasty. Fixation of osteoporotic fracture is challenging as the current metal implants made of stainless steel or titanium that are rather rigid and bioinert, which are not favourable for enhancing fracture healing and subsequent remodelling. Magnesium (Mg) and its alloys are reported to possess good biocompatibility, biodegradability and osteopromotive effects during its in vivo degradation and now tested as a new generation of degradable metallic biomaterials. Several recent clinical studies reported the Mg-based screws for bone fixation, although the history of testing Mg as fixation implant was documented more than 100 years ago. Truthfully, Mg has its limitations as fixation implant, especially when applied at load-bearing sites because of rather rapid degradation. Currently developed Mg-based implants have only been designed for application at less or non–loading-bearing skeletal site(s). Therefore, after years research and development, the authors propose an innovative hybrid fixation system with parts composed of Mg and titanium or stainless steel to maximise the biological benefits of Mg; titanium or stainless steel in this hybrid system can provide enough mechanical support for fractures at load-bearing site(s) while Mg promotes the fracture healing through novel mechanisms during its degradation, especially in patients with osteoporosis and other metabolic disorders that are unfavourable conditions for fracture healing. This hybrid fixation strategy is designed to effectively enhance the osteoporotic fracture healing and may potentially also reduce the refracture rate.The translational potential of this article: This article systemically reviewed the combination utility of different metallic implants in orthopaedic applications. It will do great contribution to the further development of internal orthopaedic implants for fracture fixation. Meanwhile, it also introduced a titanium–magnesium hybrid fixation system as an alternative fixation strategy, especially for osteoporotic patients.
“…Stainless steel was introduced in the 1920s and allowed better biocompatibility of bone screws [5]. In the 1940s, the Belgian surgeon Robert Danis (the “father of modern osteosynthesis”) further modified screw designs to applications specific to human bone by implementing the following three technical features [6]:A change of the ratio from the exterior screw diameter to core diameter from 4:3 in industry metal screws, to 3:2 in orthopedic screws;A reduction of thread surface area to 1/6, based on the notion that bone strength is about 1/6 of the strength of metal;A change from the classic industrial V-shaped thread design to buttress threads (Fig. 1), based on the postulated increased pull-out resistance of buttress threads.Fig.…”
Section: Background: a Brief History Of Bone Screw Designmentioning
confidence: 99%
“…Robert Danis’ pioneering work on internal fixation, including improved screw design and plate technology, preceded the foundation of the AO (“Arbeitsgemeinschaft für Osteosynthesefragen”) in 1958 in Switzerland [6, 7]. One of the fundamental subsequent achievements of the AO was the global standardization of surgical principles and techniques, and the introduction of a uniform design for orthopedic implants and instruments [5].…”
Section: Background: a Brief History Of Bone Screw Designmentioning
confidence: 99%
“…Most of the currently applied screws in orthopedic surgery utilize a form of the buttress thread [5, 6]. However, the buttress thread suffers from several intrinsic limitations.…”
Section: Limitations Of Conventional Buttress Screwsmentioning
BackgroundConventional screws used for fracture fixation in orthopedic surgery continue to rely on the historic buttress thread design. While buttress screws generally provide solid resistance against unidirectional axial loading forces, their design suffers from several limitations, as the buttress thread does not adequately resist multiaxial forces. Furthermore, the buttress screw is prone to stripping at the bone-screw interface and can cause microfracturing of the surrounding bone due to its thread design. Standard buttress screws are therefore at risk of adverse postoperative outcomes secondary to failure of bone fixation. A new patented Bone-Screw-Fastener was recently designed that is based on an interlocking thread technology. This new fastener provides distributive forces from the threads onto the bone and therefore resists loads in multiple directions. The underlying concept is represented by a “female thread” bone cutting technology designed to maximize bone volume, preserve bone architecture, and create a circumferential interlocking interface between the implant and bone that protects the thread from stripping and from failing to multiaxial forces.Presentation of the hypothesisWe hypothesize that the new Bone-Screw-Fastener overcomes the classic shortcomings of conventional orthopedic screws with buttress threads by ease of insertion, improved bone preservation, increased resistance to off-axis multidirectional loading forces and to stripping of the threads. These advanced biomechanical and biological properties can potentially mitigate the classic limitations of conventional buttress screws by providing better resistance to implant failure under physiological loads, preserving bone biology, and thus potentially improving patient outcomes in the future.Testing the hypothesisThe presumed superiority of the new fastener will require testing and validation in well-designed prospective multicenter randomized controlled trials (RCTs), using the conventional buttress screw as control.Implications of the hypothesisOnce validated in multicenter RCTs, the new Bone-Screw-Fastener may drive a change in paradigm with regard to its innovative biomechanical principles and biologic bone preservation for surgical applications requiring screw fixation.
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