Clinical safety and efficacy of a fully automated robot for magnetic resonance imaging-guided breast biopsy.

BACKGROUND: Magnetic resonance imaging (MRI)-guided biopsies are an accurate, but technically challenging, method for screening and diagnosis of breast lesions. This study assesses the safety and efficacy of an Image Guided Automated Robot (IGAR) in performing breast biopsies compared to manual procedures. METHODS: Safety was determined from adverse events (AEs) and device deficiencies. Efficacy was assessed using targeting accuracy, number of successful biopsies, pain and scar scores, patient discomfort, and radiologist-determined ease-of-use. RESULTS: All seven procedures in phase I were successfully and safely completed with no AEs and one device deficiency. The 23 IGAR biopsies in phase II outperformed the 18 manual biopsies in 1-week pain scores (p = 0.027), scarring at 1-week (p = 0.035), 1-month (p = 0.004), and components of comfort and ease-of-use. Phase II had seven and three AEs in the IGAR and manual groups, respectively (p = 0.317), with no serious AEs and nine device deficiencies. CONCLUSIONS: The IGAR system is safe and effective for breast biopsy procedures. The results from these trials indicate the IGAR system as a potentially viable alternative to manual breast biopsy procedures.

The diagnostic precision of computed tomography for traumatic cervical spine injury: An in vitro biomechanical investigation.

BACKGROUND: CT is considered the best method for vertebral fracture detection clinically, but its efficacy in laboratory studies is unknown. Therefore, our objective was to determine the sensitivity, precision, and specificity of high-resolution CT imaging compared to detailed anatomic dissection in an axial compression and lateral bending cervical spine biomechanical injury model. METHODS: 35 three-vertebra human cadaver cervical spine specimens were impacted in dynamic axial compression (0.5 m/s) at one of three lateral eccentricities (low 5% of the spine transverse diameter, middle 50%, high 150%) and two end conditions (19 constrained lateral translation and 16 unconstrained). All specimens were imaged using high resolution CT imaging (246 µm). Two clinicians (spine surgeon and neuroradiologist) diagnosed the vertebral fractures based on 34 discrete anatomical structures using both the CT images and anatomical dissection. FINDINGS: The sensitivity of CT was highest for fractures of the facet joint (59%) and vertebral endplate (57%), and was lowest for pedicle (13%) and lateral mass fractures (23%). The precision of CT was highest for spinous process fractures (83%) and lowest for pedicle (21%), uncinate process and lateral mass (both 23%) fractures. The specificity of CT exceeded 90% for all fractures. The Kappa value between the two reviewers was 0.52, indicating moderate agreement. INTERPRETATION: In this in vitro cervical spine injury model, high resolution CT scanning missed many fractures, notably those of the lateral mass and pedicle. This finding is potentially important clinically, as the integrity of these structures is important to clinical stability and surgical fixation planning.

The effect of end condition on spine segment biomechanics in compression with lateral eccentricity.

During axial impact compression of the cervical spine, injury outcome is highly dependent on initial posture of the spine and the orientation, frictional properties and stiffness of the impact surface. These properties influence the "end condition" the spine experiences in real-world impacts. The effect of end condition on compression and sagittal plane bending in laboratory experiments is well-documented. The spine is able to escape injury in an unconstrained flexion-inducing end condition (e.g. against an angled, low friction surface), but when the end condition is constrained (e.g. head pocketing into a deformable surface) the following torso can compress the aligned spine causing injury. The aim of this study was to determine whether this effect exists under combined axial compression and lateral bending. Over two experimental studies, twenty-four human three vertebra functional spinal units were subjected to controlled dynamic axial compression at two levels of laterally eccentric force and in two end conditions. One end condition allowed the superior spine to laterally rotate and translate (T-Free) and the other end condition allowed only lateral rotation (T-Fixed). Spine kinetics, kinematics, injuries and occlusion of the spinal canal were measured during impact and pre- and post-impact flexibility. In contrast to typical spine responses in flexion-compression loading, the cervical spine specimens in this study did not escape injury in lateral bending when allowed to translate laterally. The specimen group that allowed lateral translation during compression had more injuries at high laterally eccentric force, saw greater peak canal occlusions and post-impact flexibility than constrained specimens.

A neck compression injury criterion incorporating lateral eccentricity.

There is currently no established injury criterion for the spine in compression with lateral load components despite this load combination commonly contributing to spinal injuries in rollover vehicle crashes, falls and sports. This study aimed to determine an injury criterion and accompanying tolerance values for cervical spine segments in axial compression applied with varying coronal plane eccentricity. Thirty-three human cadaveric functional spinal units were subjected to axial compression at three magnitudes of lateral eccentricity of the applied force. Injury was identified by high-speed video and graded by spine surgeons. Linear regression was used to define neck injury tolerance values based on a criterion incorporating coronal plane loads accounting for specimen sex, age, size and bone density. Larger coronal plane eccentricity at injury was associated with smaller resultant coronal plane force. The level of coronal plane eccentricity at failure appears to distinguish between the types of injuries sustained, with hard tissue structure injuries more common at low levels of eccentricity and soft tissue structure injuries more common at high levels of eccentricity. There was no relationship between axial force and lateral bending moment at injury which has been previously proposed as an injury criterion. These results provide the foundation for designing and evaluating strategies and devices for preventing severe spinal injuries.

Comparison of foam-based and spring-loaded dry EEG electrodes with wet electrodes in resting and moving conditions.

The introduction of dry electrodes for EEG measurements has opened up possibilities of recording EEG outside of standard clinical environments by reducing required preparation and maintenance. However, the signal quality of dry electrodes in comparison with wet electrodes has not yet been evaluated under activities of daily life (ADL) or high motion tasks. In this study, we compared the performances of foam-based and spring-loaded dry electrodes with wet electrodes under three different task conditions: resting state, walking, and cycling. Our analysis showed that signals obtained by the 2 types of dry electrodes and obtained by wet electrodes displayed high correlation for all conditions, while being prone to similar environmental and electrode-based artifacts. Overall, our results suggest that dry electrodes have a similar signal quality in comparison to wet electrodes during motion and may be more practical for use in mobile and real-time motion applications due to their convenience. In addition, we conclude that as with wet electrodes, post-processing can mitigate motion artifacts in ambulatory EEG acquisition.

Moment measurements in dynamic and quasi-static spine segment testing using eccentric compression are susceptible to artifacts based on loading configuration.

The tolerance of the spine to bending moments, used for evaluation of injury prevention devices, is often determined through eccentric axial compression experiments using segments of the cadaver spine. Preliminary experiments in our laboratory demonstrated that eccentric axial compression resulted in "unexpected" (artifact) moments. The aim of this study was to evaluate the static and dynamic effects of test configuration on bending moments during eccentric axial compression typical in cadaver spine segment testing. Specific objectives were to create dynamic equilibrium equations for the loads measured inferior to the specimen, experimentally verify these equations, and compare moment responses from various test configurations using synthetic (rubber) and human cadaver specimens. The equilibrium equations were verified by performing quasi-static (5 mm/s) and dynamic experiments (0.4 m/s) on a rubber specimen and comparing calculated shear forces and bending moments to those measured using a six-axis load cell. Moment responses were compared for hinge joint, linear slider and hinge joint, and roller joint configurations tested at quasi-static and dynamic rates. Calculated shear force and bending moment curves had similar shapes to those measured. Calculated values in the first local minima differed from those measured by 3% and 15%, respectively, in the dynamic test, and these occurred within 1.5 ms of those measured. In the rubber specimen experiments, for the hinge joint (translation constrained), quasi-static and dynamic posterior eccentric compression resulted in flexion (unexpected) moments. For the slider and hinge joints and the roller joints (translation unconstrained), extension ("expected") moments were measured quasi-statically and initial flexion (unexpected) moments were measured dynamically. In the cadaver experiments with roller joints, anterior and posterior eccentricities resulted in extension moments, which were unexpected and expected, for those configurations, respectively. The unexpected moments were due to the inertia of the superior mounting structures. This study has shown that eccentric axial compression produces unexpected moments due to translation constraints at all loading rates and due to the inertia of the superior mounting structures in dynamic experiments. It may be incorrect to assume that bending moments are equal to the product of compression force and eccentricity, particularly where the test configuration involves translational constraints and where the experiments are dynamic. In order to reduce inertial moment artifacts, the mass, and moment of inertia of any loading jig structures that rotate with the specimen should be minimized. Also, the distance between these structures and the load cell should be reduced.

Transmission of force in the lumbosacral spine during backward falls.

STUDY DESIGN: Mathematical model, combined with and verified using human subject data. OBJECTIVE: (1) To develop and verify a lumped-parameter mathematical model for prediction of spine forces during backward falls; (2) to use this model to evaluate the effect of floor stiffness on spine forces during falls; and (3) to compare predicted impact forces with forces previously measured to fracture the spine. SUMMARY OF BACKGROUND DATA: Vertebral fractures are the most common osteoporotic fractures and commonly result from falls from standing height. Compliant flooring reduces the force at the ground during a backward fall from standing; however, the effect on spine forces is unknown. METHODS: A 6-df model of the body was developed and verified using data from 10 human subjects falling from standing onto 3 types of compliant floors (soft: 59 kN/m, medium: 67 kN/m, and firm: 95 kN/m). The simulated ground forces were compared with those measured experimentally. The model was also used to assess the effect of floor stiffness on spine forces at various intervertebral levels. RESULTS: There was less than 14% difference between model predictions and experimentally measured peak ground reaction forces, when averaged over all floor conditions. When compared with the rigid floor, average peak spine force attenuations of 46%, 43%, and 41% were achieved with the soft, medium, and firm floors, respectively (3.7, 3.9, 4.1 kN vs. 6.9 kN at L4/L5). Spine forces were lower than those at the ground and decreased cranially (4.9, 3.9, 3.7, 3.5 kN at the ground, L5/S1, L4/L5, and L3/L4, respectively, for the soft floor). CONCLUSION: Lowering the floor stiffness (from 400 to 59 kN/m) can attenuate peak lumbosacral spine forces in a backward fall onto the buttocks from standing by 46% (average peak from 6.9 to 3.7 kN at L4/L5) to values closer to the average tolerance of the spine to fracture (3.4 kN).

Pediatric and adult three-dimensional cervical spine kinematics: effect of age and sex through overall motion.

STUDY DESIGN: Cross-sectional study. OBJECTIVE: To determine the effect of age and sex on the three-dimensional kinematics of the cervical spine. SUMMARY OF BACKGROUND DATA: Spine kinematics information has important implications for biomechanical model development, anthropomorphic test device development, injury prevention, surgical treatment, and safety equipment design. There is a paucity of data of this type available for children, and it is unknown whether cervical spine kinematics of the pediatric population is different than that of adults. The helical axis of motion (HAM) of the spine provides unique information about the quantity and quality (coupling etc.) of the measured motion. METHODS: Ninety subjects were recruited and divided into 6 groups based on sex and age (young children aged 4-10 years, older children aged 11-17 years, adults aged 25+ years). Subjects actively moved their head in axial rotation, lateral bending, and flexion/extension. An optoelectronic motion analysis system recorded the position of infrared markers placed on the first thoracic vertebrae (T1) and on tight-fitting headgear worn by the subjects. HAM parameters were calculated for the head motion with respect to T1. RESULTS: HAM location in axial rotation and flexion/extension was more anterior in young females compared to adult females. Young females had a more anterior HAM location in flexion/extension compared to young males, indicating an effect of sex. For females, the HAM locations of adults were superior to those of children in flexion/extension and lateral bending whereas in males the HAM locations of adults were inferior to those of children. Age-related differences in HAM orientation were also observed in axial rotation and lateral bending. CONCLUSION.: Cervical spine kinematics vary with age and sex. The variation in spine mechanics based on age and sex found in the present study may indicate general trends that would grow stronger in even younger children (age <4 years).