Adaptation of a clinical fixation device for biomechanical testing of the lumbar spine

In-vitro biomechanical testing is widely performed for characterizing the load-displacement characteristics of intact, injured, degenerated, and surgically repaired osteoligamentous spine specimens. Traditional specimen fixture devices offer an unspecified rigidity of fixation, while varying in the associated amounts and reversibility of damage to and “coverage” of a specimen – factors that can limit surgical access to structures of interest during testing as well as preclude the possibility of testing certain segments of a specimen. Therefore, the objective of this study was to develop a specimen fixture system for spine biomechanical testing that uses components of clinically available spinal fixation hardware and determine whether the new system provides sufficient rigidity for spine biomechanical testing. Custom testing blocks were mounted into a robotic testing system and the angular deflection of the upper fixture was measured indirectly using linear variable differential transformers. The fixture system had an overall stiffness 37.0, 16.7 and 13.3 times greater than a typical human functional spine unit for the flexion/extension, axial rotation and lateral bending directions respectively – sufficient rigidity for biomechanical testing. Fixture motion when mounted to a lumbar spine specimen revealed average motion of 0.6, 0.6, and 1.5° in each direction. This specimen fixture method causes only minimal damage to a specimen, permits testing of all levels of a specimen, and provides for surgical access during testing.     

Statistical shape modelling of the thoracic spine for the development of pedicle screw insertion guides

Spinal fixation and fusion are surgical procedures undertaken to restore stability in the spine and restrict painful or degenerative motion. Malpositioning of pedicle screws during these procedures can result in major neurological and vascular damage. Patient-specific surgical guides offer clear benefits, reducing malposition rates by up to 25%. However, they suffer from long lead times and the manufacturing process is dependent on third-party specialists. The development of a standard set of surgical guides may eliminate the issues with the manufacturing process. To evaluate the feasibility of this option, a statistical shape model (SSM) was created and used to analyse the morphological variations of the T4–T6 vertebrae in a population of 90 specimens from the Visible Korean Human dataset (50 females and 40 males). The first three principal components, representing 39.7% of the variance within the population, were analysed. The model showed high variability in the transverse process (~ 4 mm) and spinous process (~ 4 mm) and relatively low variation (< 1 mm) in the vertebral lamina. For a Korean population, a standardised set of surgical guides would likely need to align with the lamina where the variance in the population is lower. It is recommended that this standard set of surgical guides should accommodate pedicle screw diameters of 3.5–6 mm and transverse pedicle screw angles of 3.5°–12.4°.

     

A simplified procedure for mechanical testing of lumbar spinal fixation implants]

On the basis of the current ASTM and ISO standard proposals, a simplified test procedure for spinal fixation implants has been developed. It comprises static and dynamic tests aimed at evaluating the stiffness and strength of various different internal implants. Different methods of mounting the pedicle screws to the test device are shown to significantly affect the characteristic values and failure mechanisms of the implants. The feasibility of the procedure was investigated by comparing 7 different internal fixation implants. The reproducible results revealed general differences associated with the material, dimensions and design, which latter in particular correlated with the specific failure mechanisms. For longer-term in situ duration, testing of these implants should be expanded to include an analysis of wear and corrosion properties.     

A device for testing mechanical properties of biological materials--the "Biodyne".

An electromechanical servo-controlled device has been developed. This device can be used to test the mechanical behavior of a wide variety of biological soft tissues. Control and execution of material testing procedures such as stress-strain, vibration, relaxation, creep etc. can be performed by manual operation of the device or by interfacing it with a laboratory type minicomputer. Experiments on excitable tissues such as muscle can also be executed. The design details and system performance are discussed.     

Radio-translucent 3-axis mechanical testing rig for the spine in micro-CT

To date, no apparatus has yet been devised which would allow the study of bone microstructure of the whole vertebrae under mechanical loading. This paper outlines the design and development of a 3-axis radio-translucent mechanical testing rig for spinal research and testing. This rig is to be used in conjunction with a Shimadzu micro-CT scanner. Several tests were conducted to verify the feasibility of the rig design. First, the maximum range of deformation in compression, flexion\extension, and lateral bending that could be exerted on a goat lumbar functional spinal unit was evaluated using the noncontact digital markers method. Stepwise compression loading was also conducted on a single porcine vertebra and the loading data was compared to results obtained from an industrial grade compression testing machine. Finally, micro-CT scans of a porcine vertebra prior to and at a compression failure strain were obtained. The rig was confirmed to be able to exert pure moment loading in the above mentioned modes of deformation and the extent of deformation was comparable to previous documented results. The stepwise compression loading conducted in the rig was also found to effectively approximate a continuous loading of the same specimen in an industrial grade compression testing machine. Finally, resultant micro-CT images of isotropic resolution 32.80 mum of a porcine vertebra loaded in the rig were obtained. For the first time, trabecular microarchitecture detail of a whole vertebra buckling under 12.1% failure compression strain loading was studied using voxel-data visualization software. These initial series of tests verify the feasibility of the rig as an apparatus incorporating spinal testing and imaging.     

A method for the identification of in-vivo segmental stiffness properties of the spine

A numerical algorithm is used to estimate in-vivo segmental stiffness properties of individual spine segments based upon existing load-displacement data. A static nonlinear finite element model stimulates a pathological spine and corrective instrumentation system. A systematic procedure for establishing the model's stiffness parameters is described, in the form of a nonlinear constrained optimal design problem. The numerical method is demonstrated using as an example a case of adolescent idiopathic scoliosis requiring corrective surgery.     

Biomechanical effects of posterior pedicle fixation techniques on the adjacent segment for the treatment of thoracolumbar burst fractures: a biomechanical analysis

Abstract

Posterior pedicle fixation technique is a common method for treating thoracolumbar burst fractures, but the effect of different fixation techniques on the postoperative spinal mechanical properties has not been clearly defined, especially on adjacent segments. A finite element model of T10-L2 with moderate T12 vertebra burst fracture was constructed to investigate biomechanical behavior of three posterior pedicle screw fixation techniques. Compared with traditional short-segment 4 pedicle screw fixation (TS-4) and intermediate long-segment 6 pedicle screw fixation (IL-6), mono-segment 4 pedicle screw fixation (MS-4) provides a safer surgical selection to prevent the secondary degeneration of adjacent segments in the long-term.     

Estimation of the mechanical lifetime of dental restorations: method and preliminary results

To assess the clinical performance of restorative materials with respect to mechanical failure, the shape of the restoration, the strength and fatigue properties and the loading history are important. This study deals with the feasibility of a method to estimate the mechanical lifetime of dental restorations. The method takes into account that the mechanical lifetime is a stochastic quantity determined by shape, strength and fatigue properties and by the cyclic nature of the mastication forces. The general outline of the method is described and the necessary experimental data are discussed. Preliminary estimates of the lifetime of a composite and an amalgam restoration are made. The method is found to be feasible and the estimated lifetimes of the restoration are of the same order of magnitude as found clinically.     

Effectiveness of pedicle screw inclusion at the fracture level in short-segment fixation constructs for the treatment of thoracolumbar burst fractures: a computational biomechanics analysis

When treating thoracolumbar burst fractures (BF), short-segment posterior fixation (SSPF) represents a less invasive alternative to the traditional long-segment posterior fixation (LSPF) approach. However, hardware failure and loss of sagittal alignment have been reported in patients treated with SSPF. Including pedicle screws at the fracture level in SSPF constructs has been proposed to improve stiffness and reliability of the construct. Accordingly, the biomechanical performance of the proposed construct was compared to LSPF via a computational analysis. Pedicle screws at fracture level improved the performance of the short-segment construct. However, LSPF still represent a biomechanically superior option for treating thoracolumbar BF.     

Evaluating the stability of fracture fixation systems: mechanical device for evaluation of 3-D stiffness in vitro]

Different fixation systems are used for fracture and defect treatment. A prerequisite for complication free healing is sufficient mechanical stability of the osteosynthesis. In vitro investigations offer the possibility of both analysing and assessing the pre-clinical fixation stability. Due to the complex loading environment in vivo, stiffness analysis should include a complete determination of the stiffness under standardised conditions. Based on a mathematical procedure to calculate the 3-D stiffness, a mechanical testing device for the 3-D loading of fixation systems was designed and integrated in the existing test set-up. The set-up consisted of a material testing machine to produce the necessary loads and an optical measurement device to detect the resulting inter-fragmentary movements. To validate the testing device, the 3-D stiffness matrices of different Ilizarov fixator configurations were determined and compared. The good reproducibility of the test was reflected in the small intra-individual variability of the stiffness components. A distinct direction dependence of the fixator stiffness was observed. Increasing the number of rings led to a stiffness increase of up to 50%, especially in bending. The presented testing device allows a complete standardised determination of the stiffness of different fixation systems. It considers the direction dependence of the stiffness and creates a prerequisite for a more direct implant comparison.     

Biaxial mechanical testing of posterior sclera using high-resolution ultrasound speckle tracking for strain measurements

This study aimed to characterize the mechanical responses of the sclera, the white outer coat of the eye, under equal-biaxial loading with unrestricted shear. An ultrasound speckle tracking technique was used to measure tissue deformation through sample thickness, expanding the capabilities of surface strain techniques. Eight porcine scleral samples were tested within 72 h postmortem  . High resolution ultrasound scans of scleral cross-sections along the two loading axes were acquired at 25 consecutive biaxial load levels. An additional repeat of the biaxial loading cycle was performed to measure a third normal strain emulating a strain gage rosette for calculating the in-plane shear. The repeatability of the strain measurements during identical biaxial ramps was evaluated. A correlation-based ultrasound speckle tracking algorithm was used to compute the displacement field and determine the distributive strains in the sample cross-sections. A Fung type constitutive model including a shear term was used to determine the material constants of each individual specimen by fitting the model parameters to the experimental stress–strain data. A non-linear stress–strain response was observed in all samples. The meridian direction had significantly larger strains than that of the circumferential direction during equal-biaxial loadings (P's<0.05$P\text{'}s<0.05$). The stiffness along the two directions was also significantly different (P=0.02) but highly correlated (R²=0.8). These results showed that the mechanical properties of the porcine sclera were nonlinear and anisotropic under biaxial loading. This work has also demonstrated the feasibility of using ultrasound speckle tracking for strain measurements during mechanical testing.