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.

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.

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.

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.