Development and evaluation of sex-specific thoracolumbar spine finite element models to study spine biomechanics.

Musculoskeletal disorders and low back pain (LBP) are common global afflictions, with a higher prevalence observed in females. However, the cause of many LBP cases continues to elude researchers. Current approaches seldom consider differences in male and female spines. Thus, this study aimed to compare the load distribution between male and female spines through finite element modeling. Two finite element models of the spine, one male and one female, were developed, inclusive of sex-specific geometry and material properties. The models consisted of the vertebrae, intervertebral discs (IVD), tendons, surrounding spinal muscles, and thoracolumbar fascia and were subjected to loading conditions simulating flexion and extension. Following extensive validation against published literature, intersegmental rotation, IVD stress, and vertebral body stress were evaluated. The female model demonstrated increased magnitudes for rotation and stresses when compared to the male model. Results suggest that the augmented stresses in the female model indicate an increased load distribution throughout the spine compared to the male model. These findings may corroborate the higher prevalence of LBP in females. This study highlights the importance of using patient- and sex-specific models for patient analyses and care.

Biomechanical evaluation of the thoracolumbar spine comparing healthy and irregular thoracic and lumbar curvatures.

BACKGROUND: The geometric alignment of the spine plays an integral role in stability, biomechanical loading, and consequently, pain, and a range of healthy sagittal curvatures has been identified. Spinal biomechanics when sagittal curvature is outside the optimal range remains a debate and may provide insight into the load distribution throughout the spinal column. METHOD: A thoracolumbar spine model (Healthy) was developed. Thoracic and lumbar curvatures were adjusted by 50% to create models with varying sagittal profiles: hypolordotic (HypoL), hyperlordotic (HyperL), hypokyphotic (HypoK), and hyperkyphotic (HyperK). In addition, lumbar spine models were constructed for the former three profiles. The models were subjected to loading conditions simulating flexion and extension. Following validation, intervertebral disc stresses, vertebral body stresses, disc heights, and intersegmental rotations were compared across all models. RESULTS: Overall trends demonstrated that HyperL and HyperK models had a noticeable reduction in disc height and greater vertebral body stresses compared to the Healthy model. In comparison, the HypoL and HypoK models displayed opposite trends. Considering the lumbar models, the HypoL model had reduced disc stresses and flexibility, while the contrary was observed in the HyperL model. Results indicate that the models with excessive curvature may be subjected to greater stress magnitudes, while the straighter spine models may reduce these stresses. CONCLUSIONS: Finite element modeling of spine biomechanics demonstrated that variations in sagittal profiles influence the load distribution and range of motion of the spine. Considering patient-specific sagittal profiles in finite element modeling may provide valuable insight for biomechanical analyses and targeted treatments.

A Critical Comparison of Comparators Used to Demonstrate Credibility of Physics-Based Numerical Spine Models.

The ability of new medical devices and technology to demonstrate safety and effectiveness, and consequently acquire regulatory approval, has been dependent on benchtop, in vitro, and in vivo evidence and experimentation. Regulatory agencies have recently begun accepting computational models and simulations as credible evidence for virtual clinical trials and medical device development. However, it is crucial that any computational model undergo rigorous verification and validation activities to attain credibility for its context of use before it can be accepted for regulatory submission. Several recently published numerical models of the human spine were considered for their implementation of various comparators as a means of model validation. The comparators used in each published model were examined and classified as either an engineering or natural comparator. Further, a method of scoring the comparators was developed based on guidelines from ASME V&V40 and the draft guidance from the US FDA, and used to evaluate the pertinence of each comparator in model validation. Thus, this review article aimed to score the various comparators used to validate numerical models of the spine in order to examine the comparator's ability to lend credibility towards computational models of the spine for specific contexts of use.

Face and content validity of analog surgical instruments on a novel physics-driven minimally invasive spinal fusion surgical simulator.

Medical simulators are a modern-day technology that allow clinicians to acquire the skills and knowledge needed to perform complex surgical procedures. Validating these simulators is crucial prior to their integration in surgical training programs. However, surgical simulators are typically validated as a whole, without emphasizing validation of the instruments themselves. The purpose of this study was to design and validate analog surgical instruments for a novel, minimally invasive spinal fusion simulator. The surgical procedure was performed on cadavers and on a surgical simulator by experienced spine surgeons to compare and validate the analog instruments. Observations were made to assess the duration of each task and the participants' interaction with each instrument, judged by finger position and location. Immediately after the completion of the simulator trial, participants completed a questionnaire on a 5-point Likert scale. The duration of each task in the surgical procedure varied between participants and training platforms (cadaver versus simulator), while participants' interaction with the instruments was similar, regardless of the training platform. Questionnaire results yielded an average score of 3.7/5 for the instrument-related questions. Subsequently, face and content validity were established. The results suggest feasibility and value in independently validating the analog instruments used in simulator training.