Preclinical evaluation of spinal implants is a necessary step to ensure their reliability and safety before implantation. The American Society for Testing and Materials reapproved F1717 standard for the assessment of mechanical properties of posterior spinal fixators, which simulates a vertebrectomy model and recommends mimicking vertebral bodies using polyethylene blocks. This set-up should represent the clinical use, but available data in the literature are few. Anatomical parameters depending on the spinal level were compared to published data or measurements on biplanar stereoradiography on 13 patients. Other mechanical variables, describing implant design were considered, and all parameters were investigated using a numerical parametric finite element model. Stress values were calculated by considering either the combination of the average values for each parameter or their worst-case combination depending on the spinal level. The standard set-up represents quite well the anatomy of an instrumented average thoracolumbar segment. The stress on the pedicular screw is significantly influenced by the lever arm of the applied load, the unsupported screw length, the position of the centre of rotation of the functional spine unit and the pedicular inclination with respect to the sagittal plane. The worst-case combination of parameters demonstrates that devices implanted below T5 could potentially undergo higher stresses than those described in the standard suggestions (maximum increase of 22.2% at L1). We propose to revise F1717 in order to describe the anatomical worst case condition we found at L1 level: this will guarantee higher safety of the implant for a wider population of patients.

Biodegradable magnesium alloy stents (MAS) are a promising solution for long-term adverse events caused by interactions between vessels and permanent stent platforms of drug eluting stents. However, the existing MAS showed severe lumen loss after a few months: too short degradation time may be the main reason for this drawback. In this study, a new design concept of MAS was proposed and a shape optimization method with finite element analysis was applied on two-dimensional (2D) stent models considering four different magnesium alloys: AZ80, AZ31, ZM21, and WE43. A morphing procedure was utilized to facilitate the optimization. Two experiments were carried out for a preliminary validation of the 2D models with good results. The optimized designs were compared to an existing MAS by means of three-dimensional finite element analysis. The results showed that the final optimized design with alloy WE43, compared to the existing MAS, has an increased strut width by approximately 48%, improved safety properties (decreased the maximum principal stress after recoil with tissue by 29%, and decreased the maximum principal strain during expansion by 14%) and improved scaffolding ability (increased by 24%). Accordingly, the degradation time can be expected to extend. The used methodology provides a convenient and practical way to develop novel MAS designs.

No abstract

The bilateral double parallel rods configuration resulted the best to reduce the stresses on the spinal fixators at the osteotomy site. However, the high loads acting on the rods with respect to the physiologic condition could slow down the bone healing at the osteotomy site.

4.

Crosslinked vitamin-E-stabilized polyethylene acetabular cups were compared with both commercially available conventional and custom-crosslinked polyethylene acetabular cups in terms of wear behavior, in a hip joint simulator for five millions cycles, using bovine calf serum as lubricant. We correlated the wear experiments results with the chemical characterization of the investigated materials: Fourier transformed infrared (FTIR) spectroscopic analyses, differential scanning calorimetry, and crosslink density measurements were used to assess the chemical characteristics of the pristine materials. In addition, further FTIR analyses and cyclohexane extraction were carried out after the simulator experiments. Lipids absorption was observed in all tested specimens and it has been shown to strongly affect the results of the wear test. Corrected gravimetric wear measurements showed that vitamin-E blended, crosslinked polyethylene wore more than the traditional crosslinked polyethylene but exhibited a much lower wear than conventional ultrahigh-molecular weight polyethylene. The chemical analyses showed that the addition of vitamin E reduced the crosslinking efficiency. Given the correlation between crosslink density and wear resistance, this gave an explanation for the observed wear performances.

The study supports the current clinical practice providing a strong biomechanical rationale to recommend 4-rod constructs based on accessory rods combined with cages adjacent to PSO site. Although weaker, the usage of accessory rods without cages and of a central satellite rod with hooks in combination with interbody spacers may also be justified. These slides can be retrieved under Electronic Supplementary Material.

The study increases our awareness on the use of the current standards to achieve meaningful results easy to compare and interpret.