Reliable in vitro method for the evaluation of the primary stability and load transfer of transfemoral prostheses for osseointegrated implantation.

Osseointegrated transfemoral prostheses experience aseptic complications with an incidence between 3% and 30%. The main aseptic risks are implant loosening, adverse bone remodeling, and post-operative periprosthetic fractures. Implant loosening can either be due to a lack of initial (primary) stability of the implant, which hinders bone ingrowth and therefore prevents secondary stability, or, in the long-term, to the progressive resorption of the periprosthetic bone. Post-operative periprosthetic fractures are most often caused by stress concentrations. A method to simultaneously evaluate the primary stability and the load transfer is currently missing. Furthermore, the measurement errors are seldom reported in the literature. In this study a method to reliably quantify the bone implant interaction of osseointegrated transfemoral prostheses in terms of primary stability and load transfer was developed, and its precision was quantified. Micromotions between the prosthesis and the host bone and the strains on the cortical bone were measured on five human cadaveric femurs with a typical commercial osseointegrated implant. To detect the primary stability of the implant and the load transfer, cyclic loads were applied, simulating the peak load during gait. Digital Image Correlation was used to measure displacements and bone strains simultaneously throughout the test. Permanent migrations and inducible micromotions were measured (three translations and three rotations), while, on the same specimen, the full-field strain distribution on the bone surface was measured. The repeatability tests showed that the devised method had an intra-specimen variability smaller than 6 µm for the translation, 0.02 degrees for the rotations, and smaller than 60 microstrain for the strain distribution. The inter-specimen variability was larger than the intra-specimen variability due to the natural differences between femurs. Altogether, the measurement uncertainties (intrinsic measurement errors, intra-specimen repeatability and inter-specimen variability) were smaller than critical levels of biomarkers for adverse remodelling and aseptic loosening, thus allowing to discriminate between stable and unstable implants, and to detect critical strain magnitudes in the host bone. In conclusion, this work showed that it is possible to measure the primary stability and the load transfer of an osseointegrated transfemoral prosthesis in a reliable way using a combination of mechanical testing and DIC.

Patient-matched osseointegrated prostheses for thumb amputees: a cadaver and feasibility study.

Thumb amputations affect 50% of hand functionality. Common solutions consist of microsurgical treatments or silicone vacuum prosthesis. Not all patients are eligible for microsurgical treatment and the use of vacuum prosthesis is often discouraged because of their instability. On the contrary, osseointegrated prosthesis provide stable retention and osseoperception. This cadaveric study evaluated the process of a patient-matched osseointegrated prosthesis for the treatment of thumb amputees. Computed tomography (CT) medical images reconstruction provided information on metacarpal stump, used as input for the parametric screw design. Preoperative planning guided the surgeons in the surgery: postoperative placement confirmed the accuracy of the preoperative planning. Surgeons were directly involved in the implant design to meet their requirements and patient needs. Implants were inserted into cadaveric specimens in one-stage surgery. A similar process can be adopted and exploited for the treatment of different levels of thumb amputations and long finger amputations.

A biomechanical study of osseointegrated patient-matched additively manufactured implant for treatment of thumb amputees.

Thumb amputations leads to 50 % loss in hand functionality. To date, silicone vacuum prosthesis and autologous transplantation are the most adopted treatment solutions: nevertheless, vacuum prostheses lack in stability and cause skin issue and surgical treatment is not always accepted by patients. Osseointegrated implants were demonstrated to enhance stability, restore osseoperception and increase the time of prosthesis use. Thumb amputations present varying stump sizes: a standard size implant cannot address specificity of each patient, while a patient matched solution can meet surgeon requirements, by geometrical features of implant. The fixture presented in the current paper is the first additively manufactured patient matched osseointegrated implant for the treatment of thumb amputees. The current work aims to verify and validate a predictive finite element model (FEM) for mechanical strength of the presented fixture. FEM was demonstrated to correctly evaluate the mechanical strength of patient matched device. Minimum strength requirements were calculated in different core diameters: FEM were experimentally validated. Safety factor of 1.5 was guaranteed. Finally, considerations on performance of the prototype were carried out by means of insertion tests in Sawbones and axial pull-out force assessment. Cadaver tests to evaluate the entire procedure and production process are ongoing.

Foot Orthosis and Sensorized House Slipper by 3D Printing.

BACKGROUND: In clinical practice, specific customization is needed to address foot pathology, which must be disease and patient-specific. To date, the traditional methods for manufacturing custom functional Foot Orthoses (FO) are based on plaster casting and manual manufacturing, hence orthotic therapy depends entirely on the skills and expertise of individual practitioners. This makes the procedures difficult to standardize and replicate, as well as expensive, time-consuming and material-wasting, as well as difficult to standardize and replicate. 3D printing offers new perspectives in the development of patient-specific orthoses, as it permits addressing all the limitations of currently available technologies, but has been so far scarcely explored for the podiatric field, so many aspects remain unmet, especially for what regards customization, which requires the definition of a protocol that entails all stages from patient scanning to manufacturing. METHODS: A feasibility study was carried out involving interdisciplinary cooperation between industrial engineers and podiatrists. To that end: (i) For patient-specific data acquisition, 3D scanning of the foot is compared to traditional casting. (ii) a modelling GD workflow is first created to design a process permitting easy creations of customized shapes, enabling the end user (the podiatrist) to interactively customize the orthoses. Then, (iii) a comparison is made between different printing materials, in order to reproduce the same mechanical behavior shown by standard orthoses. To do this, the mechanical properties of standard materials (Polycarbonate sheets), cut and hand-shaped, are compared with four groups of 3D printed samples: poly(ethylene glycol) (PETG), poly(acrylonitrile-butadiene.styrene) (ABS), polycarbonate (PC) and poly(lactic acid) (PLA) obtained by Fused Filament Fabrication (FFF). RESULTS: Differences found between the foot plaster model obtained with the plaster slipper cast in a neutral position and the model of the real foot obtained with 3D scanning in the same position can be ascribed to the non-stationarity of the patient during the acquisition process, and were limited by a locking system with which no substantial differences in the almost entire sole of the foot scan were observed. CONCLUSIONS: Using the designed GD workflow, podiatrists with limited CAD skills can easily design and interactively customize foot orthoses to adapt them to the patients' clinical needs. 3D printing enables the complex shape of the orthoses to be reproduced easily and quickly. Compared to Polycarbonate sheets (gold standard), all the printed materials were less deformable and reached lower yield stress for comparable deformation. No modifications in any of the materials as a result of printing process were observed.

Osseointegrated Metallic Implants for Finger Amputees: A Review of the Literature.

Digital trauma amputations and digital agenesis strongly affect the functionality and aesthetic appearance of the hand. Autologous reconstruction is the gold standard of treatment. Unfortunately, microsurgical options and transplantation procedures are not possible for patients who present contraindications or refuse to undergo transplantation from the toe (e.g. toe-to-thumb transplantation). To address these issues, osseointegrated finger prostheses are a promising alternative. The functional assessments registered during follow-up confirmed the promising outcomes of osseointegrated prostheses in the treatment of hand finger amputees. This review outlines (a) a detailed analysis of osseointegrated finger metallic components of the implants, (b) the surgical procedures suggested in the literature, and (c) the functional assessments and promising outcomes that demonstrate the potential of these medical osseointegrated devices in the treatment of finger amputees.

Hierarchical chitinous matrices byssus-inspired with mechanical properties tunable by Fe(III) and oxidation.

In this study the multi-scale hierarchical structure of the ß-chitin matrix from squid pen of Loligo vulgaris was used as substrate to synthesize new bio-inspired materials. Aiming to mimic the byssus peculiar mechanical properties, we chemically functionalized the ß-chitin matrix with catechols, one of the main functional groups of the byssus. The obtained matrix preserved its multi-scale structural organization and was able to chelate reversibly Fe(III). Thus, it behaved as the byssus, acting as a metal cross-linkable matrix that upon metalation increased its Young's modulus, E (>10 times). The functionalized matrix was also cross-linked by oxidation provoking an increase of the E (>10 times) and first failure stress (>5 times). The oxidation of the functionalized matrix followed by metalation slightly increased the material mechanical properties. In conclusion, we added specific bio-functionalities in a natural matrix tuning its mechanical properties without altering its multi-scale organization.

Reconstruction of proximal humeral fractures with a reduced number of screws and a reinforced bone substitute.

Multi-fragmented fractures of the proximal humerus are difficult to treat, especially in the case of osteoporotic bone. Intra-operative risks include cartilage damage when inserting multiple screws. A common post-operative complication is distal-varus collapse of the head. The aim of this study was to investigate if an Innovative technique (reduced number of screws and injection of a beta-TCP additivated partially resorbable cement) provides the same or better stability of the reconstructed head compared to the Standard technique (using more screws). A four-fragment fracture was simulated in six pairs of humeri, with partial removal of the cancellous bone to simulate osteoporotic "eggshell" defect. One humerus of each pair was repaired with a Standard (locking plate, 2 cortical and 6 locking screws), and the other with the Innovative technique (same plate, 2 cortical and only 3 locking screws, plus cement injection). The reconstructed specimens were subjected to a biomechanical test where a cyclic force of increasing amplitude was applied axially until failure. The Innovative reconstructions withstood a force 3.49 times larger than the contralateral Standard reconstructions before failure started. The maximum force before final collapse for the Innovative reconstructions was 4.24 times larger than the contralateral Standard reconstructions. These differences were statistically significant. The Innovative reconstructions, based on fewer screws and beta-TCP additivated acrylic cement, showed positive results, demonstrating better biomechanical properties compared to the Standard reconstructions. These laboratory findings, along with the advantages of a reduced number of screws, may help perform a surgically safer, and more effective procedure in osteoporotic patients.

ß-Chitin samples with similar microfibril arrangement change mechanical properties varying the degree of acetylation.

Chitin is widespread in nature and is increasingly used in synthetic process for the production of new biomaterials. Chitin degree of acetylation, crystalline structure and microfibril arrangement differentiate chemical, physical and mechanical properties. Nevertheless, no information are available on the relationship between the mechanical properties and the degree of acetylation (DA) in chitin samples in which the microfibril arrangement does not change. Here, samples of ß-chitin with decreasing DA, up to chitosan, were prepared using the squid pen of Loligo vulgaris. These samples were characterized by CP-MAS NMR spectroscopy, scanning electron microscopy, thermal analyses, synchrotron X-ray fiber diffraction and tensile tests. The results showed a similar microfibril arrangement decreasing the DA, except for the chitosan sample. The mechanical properties showed an increase of the maximum strain and a reduction of the maximum stress and Young's modulus, decreasing the DA. These changes, not linear with the DA, were related to structural changes at molecular structure level. The knowledge deriving from this study is of interest both for the understanding of the mechanical properties of chitinous biological samples, but also for the design and synthesis of new biomacromolecular materials.

Standard and line-to-line cementation of a polished short hip stem: Long-term in vitro implant stability.

The current trend is toward shorter hip stems. While there is a general agreement on the need for a cement mantle thicker than 2 mm, some surgeons prefer line-to-line cementation, where the mantle has only the thickness provided by the cement-bone interdigitation. The aim of this study was to assess if a relatively short, polished hip stem designed for a standard cementation can also be cemented line-to-line without increasing the risk of long-term loosening. Composite femurs with specific open-cell foam to allow cement-bone interdigitation were used. A validated in-vitro biomechanical cyclic test replicating long-term physiological loading was applied to femurs where the same stem was implanted with the Standard-mantle (optimal stem size) and Line-to-line (same rasp, one-size larger stem). Implant-bone motions were measured during the test. Inducible micromotions never exceeded 10 µm for both implant types (differences statistically not-significant). Permanent migrations ranged 50-300 µm for both implant types (differences statistically not-significant). While in the standard-mantle specimens there was a pronounced trend toward stabilization, line-to-line had less tendency to stabilize. The cement cracks were observed after the test by means of dye penetrants: The line-to-line specimens included the same cracks of the standard-mantle (but in the line-to-line specimens they were longer), and some additional cracks. The micromotions and cement damage were consistent with those observed in-vitro and clinically for stable stems, confirming that none of the specimens became dramatically loose. However, it seems that for this relatively short polished stem, standard-mantle cementation is preferable, as it results in less micromotion and less cement cracking. © 2018 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:2736-2744, 2018.

Graphene Materials Strengthen Aqueous Polyurethane Adhesives.

Carboxyl-functionalized graphene platelets (GP) and graphene oxide (GO) sheets were added to a commercial aqueous adhesive dispersion of thermoplastic polyurethane (TP) (Idrotex 200 from FacGB s.r.l.). For both additives, the weight percentage was of industrial interest, 0.01 and 0.1 wt %. The addition of GP/GO was carried out in a simple and scalable-up process that can be applied to other materials and additives. Mechanical, peel tests were applied on polyurethane strips (75 mm long, 15 mm wide, and 1.5 mm thick) prepared cutting extruded sheets obtained using Estane 58091, a 70D aromatic polyester-based TP. The tests with 0.01 wt % of GP showed statistically significant higher forces at first failure and maximum forces with respect to the pristine adhesive. Sample characterization was carried out with scanning electron microscopy, infrared spectroscopy, X-ray diffraction, and thermal analysis. A mechanism is suggested for the improved performance of the low-dose GP adhesive.