Comprehensive Biological Evaluation of Biomaterials Used in Spinal and Orthopedic Surgery.

Biological acceptance is one of the most important aspects of a biomaterial and forms the basis for its clinical use. The aim of this study was a comprehensive biological evaluation (cytotoxicity test, bacterial colonization test, blood platelets adhesion test and transcriptome and proteome analysis of Saos-2 cells after contact with surface of the biomaterial) of biomaterials used in spinal and orthopedic surgery, namely, Ti6Al4V ELI (Extra Low Interstitials), its modified version obtained as a result of melting by electron beam technology (Ti6Al4V ELI-EBT), polyether ether ketone (PEEK) and polished medical steel American Iron and Steel Institute (AISI) 316L (the reference material). Biological tests were carried out using the osteoblasts-like cells (Saos-2, ATCC HTB-85) and bacteria Escherichia coli (DH5α). Results showed lack of cytotoxicity of all materials and the surfaces of both Ti6Al4V ELI and PEEK exhibit a significantly higher resistance to colonization with E. coli cells, while the more porous surface of the same titanium alloy produced by electron beam technology (EBT) is more susceptible to microbial colonization than the control surface of polished medical steel. None of the tested materials showed high toxicity in relation to E. coli cells. Susceptibility to platelet adhesion was very high for polished medical steel AISI 316L, whilst much lower for the other biomaterials and can be ranked from the lowest to the highest as follows: PEEK < Ti6Al4V ELI < Ti6Al4V ELI-EBT. The number of expressed genes in Saos-2 cells exposed to contact with the examined biomaterials reached 9463 genes in total (ranging from 8455 genes expressed in cells exposed to ELI to 9160 genes in cells exposed to PEEK). Whereas the number of differentially expressed proteins detected on two-dimensional electrophoresis gels in Saos-2 cells after contact with the examined biomaterials was 141 for PEEK, 223 for Ti6Al4V ELI and 133 for Ti6Al4V ELI-EBT. Finally, 14 proteins with altered expression were identified by mass spectrometry. In conclusion, none of the tested biomaterials showed unsatisfactory levels of cytotoxicity. The gene and protein expression analysis, that represents a completely new approach towards characterization of these biomaterials, showed that the polymer PEEK causes much more intense changes in gene and protein expression and thus influences cell metabolism.

Cadaveric biomechanical testing of torque - to - failure magnitude of Bilateral Apical Vertebral Derotation maneuver in the thoracic spine.

It remains unclear what is the real safe limit of torque magnitude during Bilateral Apical Vertebral Derotation (BAVD) in thoracic curve correction. Up to author's knowledge there is no study except this one, to reproduce in-vivo real measurements and intraoperative conditions during BAVD maneuver. The objective of this study was to evaluate the torsional strength of the instrumented thoracic spine under axial rotation moment as well as to define safety limits under BAVD corrective maneuver in scoliosis surgery. 10 fresh, full-length, young and intact human cadavers were tested. After proper assembly of the apparatus, the torque was applied through its apical part, simulating thoracic curve derotation. During each experiment the torque magnitude and angular range of derotation were evaluated. For more accurate analysis after every experiment the examined section of the spine was resected from the cadaver and evaluated morphologically and with a CT scan. The average torque to failure during BAVD simulation was 73,3 ± 5,49Nm. The average angle of BAVD to failure was 44,5 ± 8,16°. The majority of failures were in apical area. There was no significant difference between the fracture occurrence of left or right side of lateral wall of the pedicle. There was no spinal canal breach and/or medial wall failure in any specimen. The safety limits of thoracic spine and efficacy of BAVD for axial plane correction in the treatment of Adolescent Idiopathic Scoliosis (AIS) were established. It provided qualitative and quantitative information essential for the spinal derotation under safe loading limits.

In vitro simulation of intraoperative vertebroplasty applied for pedicle screw augmentation. A biomechanical evaluation.

BACKGROUND AND PURPOSE: The purpose of this study was to evaluate the effect of an in vitro simulation of intraoperative vertebroplasty on embedded pedicle screws resistance to pullout. This method involved an application of acrylic cement into the vertebral bodies only after pedicle screws implementation. MATERIALS AND METHODS: For the purpose of conducting this research, the authors used the spines of fully-grown pigs. The procedure was as follows: firstly, the pedicle screws were bilaterally implemented in 10 vertebrae; secondly, cancellous bone was removed from vertebral bodies selected for screws augmentation and lastly it was replaced by polymethylmethacrylate (PMMA). Six vertebrae with implemented pedicle screws served as a control group. The pullout strength of thirty-two screws (20 augmented and 12 control) was tested. All screws were pulled out at a crosshead speed of 5mm/min. RESULTS: The PMMA-augmented screws showed a 1.3 times higher average pullout force than the control group: respectively 1539.68N and 1156.59N. In essence, no significant discrepancy was determined between average pullout forces of screws which were pulled as first when compared with consecutive contralateral ones. CONCLUSIONS: An in vitro simulation of intraoperative injection of PMMA in the vertebral body instrumented with screws (intraoperative vertebroplasty) resulted in enhancing its pullout strength by 33%. Pulling of one of the pedicular screws from the augmented vertebral body did not affect the pullout resistance of the contralateral one.

[Subsidence and its effect on the anterior plate stabilization in the course of cervical spondylodesis. Part I: definition and review of literature]. / Osiadanie i jego wplyw na uklad stabilizacji plytkowej przedniej w przebiegu spondylodezy miedzytrzonowej kregoslupa szyjnego. Czesc 1: Definicja i przeglad pismiennictwa.

A definition of subsidence in terms of spinal biomechanics is presented in the paper. Subsidence is defined as sinking of a body with a higher elasticity modulus (e.g. graft, cage, spacer) in a body characterized by a lower elasticity modulus (e.g. vertebral body), resulting in 3D changes of the spinal geometry. Magnitude of subsidence is directly proportional to the load pressure and to the difference between the elasticity modules, but inversely proportional to the area of the graft-bed interface. Both biological and mechanical qualities of the graft-bed interface are important for the subsidence process. Any excessive subsidence decreases the interbody space and produces both local and general kyphotization of the spine. This may cause destabilization of the screw-plate and/or screw-bone interfaces (e.g. pulling-out, altered angulation or breakage of the screws). A method is proposed of radiological estimating the absolute magnitude of subsidence, based on the real known length of the implanted stabilizer (e.g. plate). Clinical examples of an excessive subsidence and its impact on the stabilizing plate system are presented. Subsidence is inherent in the interbody fusion process. Endplate preservation and a dynamic modification of cervical plates may enables us to control subsidence and reduce the number of complications.