Skeletal Attachment Of Limb Prostheses Research Articles

The effect of cortical thickness and thread profile dimensions on stress and strain in bone-anchored implants for amputation prostheses

Skeletal attachment of limb prostheses ensures load transfer between the prosthetic leg and the skeleton. For individuals with lower limb amputation, these loads may be of substantial magnitude. To optimize the design of such systems, knowledge about the structural interplay between implant design features, dimensional changes, and material properties of the implant and the surrounding bone is needed. Here, we present the results from a parametric finite element investigation on a generic bone-anchored implant system of screw design, exposed to external loads corresponding to average and high ambulatory loading. Of the investigated parameters, cortical thickness had the largest effect on the stress and strain in the bone-anchored implant and in the cortical bone. 36%–44% reductions in maximum longitudinal stress in the bone-anchored implant was observed as a result of increased cortical thickness from 2 mm to 5 mm. A change in thread depth from 1.5 mm to 0.75 mm resulted in 20%–22% and 10%–18% reductions in maximum longitudinal stress in the bone-anchored implant at 2 mm and 5 mm cortical thickness respectively. The effect of changes in the thread root radius was less prominent, with 8% reduction in the maximum longitudinal stress in the bone-anchored implant being the largest observed effect, resulting from an increased thread root radius from 0.1 mm to 0.5 mm at a thread depth of 1.5 mm. Autologous transplantation of bone tissue distal to the fixture resulted in reductions in the longitudinal stress in the percutaneous abutment. The observed stress reduction of 10%–31% was dependent on the stiffness of the transplanted bone graft and the cortical thickness of surrounding bone. Results from this investigation may guide structural design optimization for bone-anchored implant systems for attachment of limb prostheses.

Low plasticity burnishing improves fretting fatigue resistance in bone-anchored implants for amputation prostheses

Fretting fatigue is a common problem for modular orthopedic implants which may lead to mechanical failure of the implant or inflammatory tissue responses due to excessive release of wear debris. Compressive residual stresses at the contacting surfaces may alleviate the problem. Here we investigate the potential of a surface enhancement method known as low plasticity burnishing (LPB) to increase the fretting fatigue resistance of bone-anchored implants for skeletal attachment of limb prostheses. Rotation bending fatigue tests performed on LPB treated and untreated test specimens demonstrate that the LPB treatment leads to statistically significantly increased resistance to fretting fatigue (LPB treated test specimens withstood on average 108,780 load cycles as compared with 37,845 load cycles for untreated test specimens, p = 0.004). LPB treated test specimens exhibited less wear at the modular interface as compared with untreated test specimens. This surface treatment may lead to reduced risk of fretting induced component failure and a reduced need for revision of implant system componentry.

Experimental evaluation of a novel concept of an implant for direct skeletal attachment of limb prosthesis

Purpose: The aim of the study was to experimentally evaluate a proposed two-part implantation system (medullary part made of PEEK composite and percutaneous part made of Ti6Al4V) for bone-anchored prosthesis and to compare it to typical press-fit design (also made of Ti6Al4V) used for the same purpose. Methods: Simplified prototypes of both implants were prepared for the research. Both implants were evaluated in vitro with the use of porcine femur (6 bones for each implant). ARAMIS vision system was used to measure strains in selected area of bone shaft, generated when putting an axial load on the implants to simulate static load bearing exercises performed during rehabilitation activities in primary stabilisation. Results: Obtained maps revealed high concentrations of strains, located near to distal part of the implant, during using a typical press-fit design with relatively low strain around the implant’s shaft. In the case of proposed design, noticeable strains occurred in the entire examined area of bone, with stronger concentration towards the proximal direction. Conclusions: Presented experimental results suggest that proposed design provides more appropriate implant-bone load transfer than typically used press-fit design. This may result in obtaining more beneficial mechanobiological stimulus which enables the researchers to achieve appropriate primary stability and maintain appropriate bone quality during its long-term use after achieving full osseointegration.

A Comparative Analysis of Standardised Threads for Use in Implants for Direct Skeletal Attachment of Limb Prosthesis: A Finite Element Analysis.

The aim of the research was to determine the optimal thread's shape to be used in implants for direct skeletal attachment of limb prosthesis. In addition, by testing appropriate parameters' modification of the suitable thread, an attempt was made to maximise its effectiveness. The analyses included three thread types described in the ISO standards: shallow, symmetrical, and asymmetrical. The obtained results suggest that shallow thread ensures the lowest equivalent and directional stress peaks generated in the bone as well as favourable stress patterns and profiles during implant loading in relation to symmetrical and asymmetrical threads. Moreover, shallow thread ensured the generation of single equivalent and directional stress peaks, while symmetrical and asymmetrical threads provided additional stress peak for equivalent as well as for each of directional peaks. Subsequently, optimisation of the shallow thread's shape was conducted by changing two relevant thread's parameters (flank angle and rounding arc) which influence the generated stress distribution. The highest reduction of stress peaks was obtained while reducing the rounding arc by 0.2 mm. Therefore, it can be stated that the proposed modification of the HA thread can lead to obtaining a higher biomechanical effectiveness of implants for direct skeletal attachment of limb prosthesis.

Finite element analysis of stresses generated in cortical bone during implantation of a novel Limb Prosthesis Osseointegrated Fixation System

The aim of this study was a biomechanical evaluation of the stresses generated in bone during implantation of the implant designed for direct skeletal attachment of limb prosthesis and a typical interference-fit implant of the reference. Using the finite element method implantation processes of both implants were modelled. The influence of two factors on stresses generated in bone was analysed: first – the radial interference between the implant and reamed marrow cavity (0.05mm up to 0.25mm) and second – the three types of implant's surfaces: polished, beaded and flaked. Obtained results show that in the case of the smallest value of radial interference (0.05mm), stresses generated in cortical bone are more appropriate for the reference implant than for the designed one. With the increase of both analysed factors generated stresses are in favour of the designed implant especially in longitudinal direction for both, implant-adjacent and deep cortical tissue (even 18 times lower) alike. Stresses patterns also present that stresses values are lower in overall volume of analysed bone's part, during implantation of the designed implant. Presented characteristics and patterns confirm that the implantation method of presented implant is safer than a method for typical interference-fit implants for direct skeletal attachment of limb prosthesis.

Biomechanical evaluation of a novel Limb Prosthesis Osseointegrated Fixation System designed to combine the advantages of interference-fit and threaded solutions.

The study was aimed at biomechanical evaluation of a novel Limb Prosthesis Osseointegrated Fixation System (LPOFS) designed to combine the advantages of interference-fit and threaded solutions. Three cases, the LPOFS (designed), the OPRA (threaded) and the ITAP (interference-fit) implants were studied. Von-Mises stresses in bone patterns and maximal values generated while axial loading on an implant placed in bone and the force reaction values in contact elements while extracting an implant were analysed. Primary and fully osteointegrated connections were considered. The results obtained for primary connection indicate more effective anchoring of the OPRA, however the LPOFS provides more appropriate stress distribution (lower stress-shielding, no overloading) in bone. In the case of fully osteointegrated connection the LPOFSs kept the most favourable stress distribution in cortical bone which is the most important long-term feature of the implant usage and bone remodelling. Moreover, in fully bound connection its anchoring elements resist extracting attempts more than the ITAP and the OPRA. The results obtained allow us to conclude that in the case of features under study the LPOFS is a more functional solution to direct skeletal attachment of limb prosthesis than the referential implants during short and long-term use.

Application of the skin and bone integrated pylon with titanium oxide nanotubes and seeded with dermal fibroblasts.

Direct skeletal attachment of limb prostheses is associated with high rate of transcutaneous infection and loosening of the fixture in the medullary canal prompting for careful assessment of various means for enhancing the skin-device and bone-device interface. The skin and bone integrated pylon system constitutes a technological platform for different modifications being evaluated previously. The current study assessed the combination of nano-treatment skin and bone integrated pylon with its pre-seeding with dermal fibroblasts. We hypothesized that this combination will enhance cell interaction with skin and bone integrated pylon compared to nano-treatment and the fibroblast seeding when done separately. The feasibility and safety of in-bone implantation of the skin and bone integrated pylon with nanotubes was investigated in vitro and in vivo in the animal model. TiO2 nanotubes were fabricated on the skin and bone integrated pylon, and the fibroblasts taken from rabbit's skin were cultured on the pylons before implantation. The in vitro experiments demonstrated higher cellular density in the samples with a nanotubular surface than in the non-modified pylons used as control. There were no postoperative complications in any of the animals during the 6-month observation period. Subsequent scanning electron microscopy of the pylon extracted from the rabbit's femur showed the stable contact between the pylon and soft tissues in comparison to control samples where the patchy fibrovascular ingrowth was detected. The promising results prompt further investigation of the integrative properties of the nanotextured skin and bone integrated pylon system seeded with dermal fibroblasts and its optimization for clinical application. The study is devoted to the development of more safe and efficient technology of direct skeletal attachment of limb prostheses aimed in improving quality of life of people with amputations.

Two‐stage implantation of the skin‐ and bone‐integrated pylon seeded with autologous fibroblasts induced into osteoblast differentiation for direct skeletal attachment of limb prostheses

Angio- and osteogenesis following the two-stage (TS) implantation of the skin- and bone-integrated pylon seeded with autologous fibroblasts was evaluated. Two consecutive animal substudies were undertaken: intramedullary subcutaneous implantation (15 rabbits) and a TS transcutaneous implantation (12 rabbits). We observed enhanced osseointegrative properties of the intramedullary porous component seeded with fibroblasts induced into osteoblast differentiation, as compared to the untreated porous titanium pylon. The three-phase scintigraphy and subsequent histological analysis showed that the level of osteogenesis was 1.5-fold higher than in the control group, and significantly so (p < 0.05). The biocompatibility was further proved by the absence of inflammatory response or encapsulation and sequestration on the histology assay. Treatment of the transcutaneous component with autologous fibroblasts was associated with nearly a 2-fold decrease in the period required for the ingrowth of dermal and subdermal soft tissues into the implant surface, as compared to the untreated porous titanium component. Direct dermal attachment to the transcutaneous implant prevented superficial and deep periprosthetic infections in rabbits in vivo.

Design features of implants for direct skeletal attachment of limb prostheses

In direct skeletal attachment (DSA) of limb prostheses, a construct is implanted into an amputee's residuum bone and protrudes out of the residuum's skin. This technology represents an alternative to traditional suspension of prostheses via various socket systems, with clear indications when the sockets cannot be properly fitted. Contemporary DSA was invented in the 1990s, and several implant systems have been introduced since then. The current review is intended to compare the design features of implants for DSA whose use in humans or in animal studies has been reported in the literature.

New method of fixation of in-bone implanted prosthesis

This article presents results on the effectiveness of a new version of the titanium porous composite skin and bone integrated pylon (SBIP). The SBIP is designed for direct skeletal attachment of limb prostheses and was evaluated in a preclinical study with three rabbits. In accordance with the study protocol, a new version of the pylon (SBIP-3) was implanted into the hind leg residuum of three rabbits. The SBIP-3 has side fins that are designed to improve the bond between the bone and pylon. The fins are positioned inside two slots precut in the bone walls; their length can be adjusted to match the thickness of the bone walls. After 13 (animal 1) or 26 (animals 2 and 3) wk, the animals were sacrificed and samples collected for histopathological analysis. The space between the fins and the bone into which they were fit was filled with fibrovascular tissue and woven bone. No substantial inflammation was found. We suggest that if further studies substantiate the present results, the proposed method can become an alternative to the established technique of implanting prostheses into the medullary canal of the hosting bone.

Recording of Electric Signal Passing Through a Pylon in Direct Skeletal Attachment of Leg Prostheses With Neuromuscular Control

Direct recordings were made of electrical signals emanating from the muscles in a rabbit's residuum. The signals were transmitted via wires attached on one end to the muscles, and on the other to an external recording system. The cable was held in a titanium tube inside a pylon that had been transcutaneously implanted into the residuum's bone. The tube was surrounded by porous titanium cladding to enhance its bond with the bone and with the skin of the residuum. This study was the first known attempt to merge the technology of direct skeletal attachment of limb prostheses with the technology of neuromuscular control of prostheses, providing a safe and reliable passage of the electrical signal from the muscles inside the residuum to the outside recording system.

Mechanical properties of totally permeable titanium composite pylon for direct skeletal attachment

Composite pylons containing a solid titanium core with drilled holes surrounded by a porous sintered titanium shell have been fabricated and tested in bending along with the raw cores and pylons composed of the porous titanium alone. The new pylons were designed with the concept of enhanced in-growth of bone and skin cells and are intended for direct skeletal attachment of limb prostheses considering requirements for long-lasting anchorage to the residuum bone and a need for a safe skin-implant seal. Load-displacement thresholds were determined after which the integrity of the porous component may be compromised. The composite pylons have a flexural strength and stiffness substantially greater than that of pylons composed of the porous titanium alone. The drilled holes in the solid insert have been shown to have virtually no effect on the flexural strength of the pylon, while meeting a requirement for total permeability of the device for unrestricted cell ingrowth. The predicted strength of the pylons and associated failure modes are in close agreement with those measured.

Mathematical modeling and mechanical and histopathological testing of porous prosthetic pylon for direct skeletal attachment.

This article presents recent results in the development of the skin and bone integrated pylon (SBIP) intended for direct skeletal attachment of limb prostheses. In our previous studies of the porous SBIP-1 and SBIP-2 prototypes, the bond site between the porous pylons and residuum bone and skin did not show the inflammation characteristically observed when solid pylons are used. At the same time, porosity diminished the strength of the pylon. To find a reasonable balance between the biological conductivity and the strength of the porous pylon, we developed a mathematical model of the composite permeable structure. A novel manufacturing process was implemented, and the new SBIP-3 prototype was tested mechanically. The minimal strength requirements established earlier for the SBIP were exceeded threefold. The first histopathological analysis of skin, bone, and the implanted SBIP-2 pylons was conducted on two rats and one cat. The histopathological analysis provided new evidence of inflammation-free, deep ingrowth of skin and bone cells throughout the SBIP structure.

Skin and bone integrated prosthetic pylon: A pilot animal study

Direct skeletal attachment of limb prostheses is a viable alternative to traditional techniques that are based on a socket-residuum interface. Direct skeletal attachment may be a better or even the only method for patients with a very short residuum and high soft-tissue volume. The problem of integrating the prosthetic pylon with residual skin during direct skeletal attachment of a limb prosthesis has not been solved, and the use of a completely porous prosthetic pylon has not been the subject of focused, systematic research. In this in vivo study, we investigated cell (osteocyte, fibroblast, and keratinocyte) adhesion and penetration into the pores of a titanium pylon implanted in Wistar rats. The porous titanium pylon was implanted in the bone of the thigh residua of four rats. Electronic scanning and morphological analysis demonstrated integration of the pylon with the surrounding skin. These findings support the possibility of developing a natural barrier against the infection associated with direct skeletal attachment of limb prostheses.