Eric H. Ledet

Background The intervertebral disc degenerates with age and has a poor propensity for regeneration. Small molecule transport plays a key role in long-term degradation and repair. Convection (bulk flow), induced by low rate cyclic loading of the intervertebral disc, has been shown to increase transport of small molecules. However, the potential therapeutic benefit of low rate cyclic loading on degenerated discs has not been described. The purpose of this study was to determine if a sustained (daily) low rate cyclic loading regimen could slow, arrest, or reverse intervertebral disc degeneration in the rabbit lumbar spine. Methods Fifty-six New Zealand white rabbits (>12 months old) were designated as either Control (no disc puncture), 8D (disc puncture followed by 8 weeks of degeneration), 16D (disc puncture followed by 16 weeks of degeneration), or Therapy (disc puncture followed by 8 weeks of degeneration and then 8 weeks of daily low rate cyclic loading). Specimens were evaluated by T2 mapping, Pfirrmann scale grading, nucleus volume, disc height index, disc morphology and structure, and proteoglycan content. Results In every metric, mean values for the Therapy group fell between Controls and 8D animals. These results suggest that sustained low rate cyclic loading had a therapeutic effect on the already degenerated disc and the regimen promoted signs of regeneration. If these results translate clinically, this approach could fulfil a significant clinical need by providing a means of non-invasively treating intervertebral disc degeneration.

The diagnosis of fracture nonunion following plate osteosynthesis is subjective and frequently ambiguous. Initially following osteosynthesis, loads applied to the bone are primarily transmitted through the plate. However, as callus stiffness increases, the callus is able to bear load proportional to its stiffness while forces through the plate decrease. The purpose of this study was to use a “smart” fracture plate to distinguish between phases of fracture healing by measuring forces transmitted through the plate. A wireless force sensor and small adapter were placed on the outside of a distal femoral locking plate. The adapter converts the slight bending of the plate under axial load into a transverse force which is measurable by the sensor. An osteotomy was created and then plated in the distal femur of biomechanical Sawbones. Specimens were loaded to simulate single‐leg stance first with the osteotomy defect empty (acute healing), then sequentially filled with silicone (early callus) and then polymethyl methacrylate (hard callus). There was a strong correlation between applied axial load and force measured by the “smart” plate. Data demonstrate statistically significant differences between each phase of healing with as little as 150 N of axial load applied to the femur. Forces measured in the plate were significantly different between acute (100%), early callus (66.4%), and hard callus (29.5%). This study demonstrates the potential of a “smart” fracture plate to distinguish between phases of healing. These objective data may enable early diagnosis of nonunion and enhance outcomes for patients.

Biomechanical testing methodologies for the spine have developed over the past 50 years. During that time, there have been several paradigm shifts with respect to techniques. These techniques evolved by incorporating state‐of‐the‐art engineering principles, in vivo measurements, anatomical structure‐function relationships, and the scientific method. Multiple parametric studies have focused on the effects that the experimental technique has on outcomes. As a result, testing methodologies have evolved, but there are no standard testing protocols, which makes the comparison of findings between experiments difficult and conclusions about in vivo performance challenging. In 2019, the international spine research community was surveyed to determine the consensus on spine biomechanical testing and if the consensus opinion was consistent with the scientific evidence. More than 80 responses to the survey were received. The findings of this survey confirmed that while some methods have been commonly adopted, not all are consistent with the scientific evidence. This review summarizes the scientific literature, the current consensus, and the authors' recommendations on best practices based on the compendium of available evidence.

Study Design.: Real time in vivo measurement of forces in the cervical spine of goats following anterior cervical discectomy and fusion (ACDF). Objective.: To measure interbody forces in the cervical spine during the time course of fusion following ACDF with plates of different stiffnesses. Summary of Background Data.: Following ACDF, the biomechanics of the arthrodesis is largely dictated by the plate. The properties of the plate prescribe the extent of load-sharing through the disc space versus the extent of stress-shielding. Load-sharing promotes interbody bone formation and stress-shielding can inhibit maturation of bone. However, these principles have never been validated in vivo. Measuring in vivo biomechanics of the cervical spine is critical to understanding the complex relationships between implant design, interbody loading, load-sharing, and the progression of fusion. Methods.: Anterior cervical plates of distinct bending stiffnesses were placed surgically following ACDF in goats. A validated custom force-sensing interbody implant was placed in the disc space to measure load-sharing in the spine. Interbody loads were measured in vivo in real time during the course of fusion for each plate. Results.: Interbody forces during flexion/extension were highly dynamic. In animals that received high stiffness plates, maximum forces were in extension whereas in animals that received lower stiffness plates, maximum forces were in flexion. As fusion progressed, interbody load magnitude decreased. Conclusion.: The magnitude of interbody forces in the cervical spine is dynamic and correlates to activity and posture of the head and neck. The magnitude and consistency of forces in the interbody space correlates to plate stiffness with more compliant plates resulting in more consistent load-sharing. The magnitude of interbody forces decreases as fusion matures suggesting that smart interbody implants may be used as a diagnostic tool to indicate the progression of interbody fusion. Level of Evidence: N/A

Study Design.: In vitro biomechanical testing of human cadaveric cervical and goat cervical motion segments. Objective.: The aim of this study was to measure the effects of plate stiffness on load-sharing, instantaneous axis of rotation (IAR), and posterior element loading after anterior cervical discectomy and fusion (ACDF). Summary of Background Data.: ACDF is intended to create an environment, which facilitates sufficient stability and biomechanical conditions to promote bone formation. The relationship between cervical plate stiffness, load-sharing, and the IAR is complex. The ideal cervical plate is sufficiently stiff to limit interbody motion but is compliant enough to facilitate load-sharing rather than stress-shielding. Methods.: Anterior cervical plates of distinct bending stiffnesses were applied to human and goat cervical motion segments following ACDF. A validated custom force-sensing interbody implant was placed in the disc space to measure load-sharing in the spine. Interbody loads, posterior element strain, and the IAR were measured during flexion/extension for each plate. Results.: Load-sharing in the interbody space, posterior element strain, and the location of the IAR were all significantly affected by plate stiffness. More compliant plates resulted in more load sharing, less posterior element strain, and a more dorsally located IAR relative to stiffer plates. Conclusion.: A more compliant plate fosters more consistent load-sharing through the entire range of flexion/extension, which may promote faster bone formation and better fusion. A more compliant plate causes less posterior element strain, which may reduce facet joint loads and in turn reduce facet joint arthrosis. An ideal plate may be one that is stiff enough to minimize interbody motion and yet compliant enough to allow consistent load-sharing and minimal increase in posterior element strain. Level of Evidence: N/A

Smart implants are implantable devices that provide not only therapeutic benefits but also have diagnostic capabilities. The integration of smart implants into daily clinical practice has the potential for massive cost savings to the health care system. Applications for smart orthopedic implants have been identified for knee arthroplasty, hip arthroplasty, spine fusion, fracture fixation and others. To date, smart orthopedic implants have been used to measure physical parameters from inside the body, including pressure, force, strain, displacement, proximity and temperature. The measurement of physical stimuli is achieved through integration of application-specific technology with the implant. Data from smart implants have led to refinements in implant design, surgical technique and strategies for postoperative care and rehabilitation. In spite of decades of research, with very few exceptions, smart implants have not yet become a part of daily clinical practice. This is largely because integration of current sensor technology necessitates significant modification to the implants. While the technology underlying smart implants has matured significantly over the last several decades, there are still significant technical challenges that need to be overcome before smart implants become part of mainstream health care. Sensors for next-generation smart implants will be small, simple, robust and inexpensive and will necessitate little to no modification to existing implant designs. With rapidly advancing technology, the widespread implementation of smart implants is near. New sensor technology that minimizes modifications to existing implants is the key to enabling smart implants into daily clinical practice.

Smart implants have the potential to enable personalized care regimens for patients. However, the integration of smart implants into daily clinical practice is limited by the size and cost of available sensing technology. Passive resonant sensors are an attractive alternative to traditional sensing technologies because they obviate the need for on-sensor signal conditioning or telemetry and are substantially simpler, smaller, less expensive, and more robust than other sensing methods. We have developed a novel simple, passive sensing platform that is adaptable to a variety of applications. Sensors consist of only two disconnected parallel Archimedean spiral coils and an intervening solid dielectric layer. When exposed to force or pressure, the resonant frequency of the circuit shifts which can be measured wirelessly. We fabricated prototype pressure sensors and force sensors and compared their performance to a lumped parameter model which predicts sensor behavior. The sensors exhibited a linear response (R² > 0.91) to dynamic changes in pressure or force with excellent sensitivity. Experimental data were within 13.3% and 6.2% of the values predicted by the model for force and pressure respectively. Results demonstrate that the sensors can be adapted to measure various measurands through a span of sensitivities and ranges by appropriate selection of the intervening layer.

Total knee arthroplasty is a common orthopaedic procedure conducted in the United States with approximately 700,000 surgeries performed annually. A common complication following total knee arthroplasty is anterior knee pain which affects tens to hundreds of thousands of people each year. The exact mechanism that leads to anterior knee pain remains unknown, but improper component selection may cause pathologic loading of the knee which leads to pain. Measuring loads in the knee to elucidate the mechanisms underlying anterior knee pain remains a challenge because the joints are so small. Using novel wireless sensor technology, we have developed and validated the first "smart" patellar implant capable of measuring force magnitude and force distribution in the knee. Implantable force sensors were calibrated and tested through the range of physiologic loading. Three sensors were then interfaced with a Zimmer patellar implant and placed into a custom loading apparatus. The smart patellar implant was then incrementally loaded from 0-500 N. Sensor signals were all recorded simultaneously in real time to measure the load across the patellofemoral joint. Results demonstrated that the smart patellar implant was able to accurately measure the load being transmitted across the simulated patellofemoral joint.

One of the most common complications from long-term wheelchair use or bed rest is pressure ulcers. Pressure ulcers have significant morbidity and are associated with high mortality. Prolonged sitting can cause high pressures in the skin and subcutaneous tissue which can lead to local ischemia and breakdown of skin. Rapid relief of pressure prevents ulcer formation. One prevention strategy is to change the temporal distribution of pressure at the interface between user and surface so that no one area is subjected to high pressures for long periods of time. While there are several dynamic interfaces in use currently, there is no definitive evidence of enhanced pressure ulcer prevention with their use. The purpose of this research was to parametrically evaluate interface array sizes, shapes and patterns for dynamic support surfaces to optimize pressure redistribution to prevent pressure ulcers. Finite element analyses, anatomical phantom deep tissue pressure measurements and interface pressure mapping were used to test various support geometries and sizes and different array spacing and patterns. Results indicate that modulating pressure in an array of supports that are equally spaced is not effective. Only interrupted pattern arrays resulted in sufficient pressure reduction. These data suggest that dynamic surface supports can be optimized based on the geometry and size of the individual supports and the pattern of the array to further reduce the likelihood of pressure ulcer formation.