UBC Neck C4-C5: An Anatomically and Biomechanically Accurate Surrogate C4-C5 Functional Spinal Unit.

Millions of people worldwide suffer from spinal cord injuries (SCIs) and traumatic brain injuries (TBIs) annually. Safety devices meant to protect against SCIs and TBIs, such as helmets, airbags, seat belts, and compliant floors are often evaluated with the use of anthropometric test devices (ATD s); however, there are currently no neck surrogates appropriate for the multiplane loading that often occurs in real-world scenarios leading to injury. As such, our objective in this study was to design and create an anatomically correct functional spinal unit (FSU) that produces a repeatable and biofidelic response to lateral bending, axial rotation, and quasistatic flexion-extension motion. This is a critical step in developing a biofidelic omnidirectional surrogate that can be used in future evaluations of safety devices in transportation, occupational, and sports settings. To create a biofidelic C4-C5 FSU, anatomically accurate C4 and C5 vertebrae were designed and manufactured using a 3D printer using geometry derived from the CT scans of a healthy 31-year-old male. Potential intervertebral disc and ligament surrogate materials were tested in compression and tension, respectively, to select representative materials for the surrogate intervertebral disc and cervical ligaments. The C4-C5 FSU was assembled and tested repeatedly in quasistatic flexion-extension, axial rotation, and lateral bending. Kinematic results were captured and compared to previously published cadaver data. The surrogate disc showed excellent Biofidelity (ISO/TR 9790) in compression, and the surrogate ligaments were within 25 N/mm of linear cadaveric stiffness ranges. The assembled FSU named UBC Neck C4-C5 showed good biofidelity under quasistatic axial rotation, lateral bending, flexion-extension, and coupled motion (ISO/TR 9790). However, the instantaneous centre of rotation was not similar to ex vivo or in vivo published studies. The UBC Neck C4-C5 FSU resulted in good biofidelity ratings and will inform future construction of a full surrogate neck to be used in the testing of head and neck safety equipment.

Load-Sharing and Kinematics of the Human Cervical Spine Under Multi-Axial Transverse Shear Loading: Combined Experimental and Computational Investigation.

The cervical spine experiences shear forces during everyday activities and injurious events yet there is a paucity of biomechanical data characterizing the cervical spine under shear loading. This study aimed to (1) characterize load transmission paths and kinematics of the subaxial cervical spine under shear loading, and (2) assess a contemporary finite element cervical spine model using this data. Subaxial functional spinal units (FSUs) were subjected to anterior, posterior, and lateral shear forces (200 N) applied with and without superimposed axial compression preload (200 N) while monitoring spine kinematics. Load transmission paths were identified using strain gauges on the anterior vertebral body and lateral masses and a disc pressure sensor. Experimental conditions were simulated with cervical spine finite element model FSUs (GHBMC M50 version 5.0). The mean kinematics, vertebral strains, and disc pressures were compared to experimental results. The shear force-displacement response typically demonstrated a toe region followed by a linear response, with higher stiffness in anterior shear relative to lateral and posterior shear. Compressive axial preload decreased posterior and lateral shear stiffness and increased initial anterior shear stiffness. Load transmission patterns and kinematics suggest the facet joints play a key role in limiting anterior shear while the disc governs motion in posterior shear. The main cervical spine shear responses and trends are faithfully predicted by the GHBMC cervical spine model. These basic cervical spine biomechanics and the computational model can provide insight into mechanisms for facet dislocation in high severity impacts, and tissue distraction in low severity impacts.

Skiing and snowboarding head injury: A retrospective centre-based study and implications for helmet test standards.

BACKGROUND: Head injury occurs in up to 47% of skiing or snowboarding injuries and is the predominant cause of death in these sports. In most existing literature reporting injury type and prevalence, head injury mechanisms are underreported. Thus, protective equipment design relies on safety evaluation test protocols that are likely oversimplified. This study aims to characterize severity and mechanism of head injuries suffered while skiing and snowboarding in a form appropriate to supplement existing helmet evaluation methods. METHODS: A 6-year, multicentre, retrospective clinical record review used emergency databases from two major trauma centres and Coroner's reports to identify relevant cases which indicated head impact. Records were investigated to understand the relationships between helmet use, injury type and severity, and injury mechanism. Descriptive statistics and odds ratios aided interpretation of the data. FINDINGS: The snow sport head injury database included 766 cases. "Simple fall", "jump impact" and "impact with object" were the most common injury mechanisms while concussion was observed to be the most common injury type. Compared to "edge catch", moderate or serious head injury was more common for "fall from height" (OR = 4.69; 95% CI = 1.44-16.23; P = 0.05), "jump impact" (OR = 3.18; 95% CI = 1.48-7.26; P = 0.01) and "impact with object" (OR = 2.44; 95% CI = 1.14-5.56; P = 0.05). Occipital head impact was associated with increased odds of concussion (OR = 7.46; 95% CI = 4.55-12.56; P = 0.001). INTERPRETATION: Snow sport head injury mechanisms are complex and cannot be represented through a single impact scenario. By relating clinical data to injury mechanism, improved evaluation methods for protective measures and ultimately better protection can be achieved.

Technique and preliminary findings for in vivo quantification of brain motion during injurious head impacts.

Computational models of the human brain are widely used in the evaluation and development of helmets and other protective equipment. These models are often attempted to be validated using cadaver tissue displacements despite studies showing neural tissue degrades quickly after death. Addressing this limitation, this study aimed to develop a technique for quantifying living brain motion in vivo using a closed head impact animal model of traumatic brain injury (TBI) called CHIMERA. We implanted radiopaque markers within the brain of three adult ferrets and resealed the skull while the animals were anesthetized. We affixed additional markers to the skull to track skull kinematics. The CHIMERA device delivered controlled, repeatable head impacts to the head of the animals while the impacts were fluoroscopically stereo-visualized. We observed that 1.5 mm stainless steel fiducials (∼8 times the density of the brain) migrated from their implanted positions while neutral density targets remained in their implanted position post-impact. Brain motion relative to the skull was quantified in neutral density target tests and showed increasing relative motion at higher head impact severities. We observed the motion of the brain lagged behind that of the skull, similar to previous studies. This technique can be used to obtain a comprehensive dataset of in vivo brain motion to validate computational models reflecting the mechanical properties of the living brain. The technique would also allow the mechanical response of in vivo brain tissue to be compared to cadaveric preparations for investigating the fidelity of current human computational brain models.

Radiography used to measure internal spinal cord deformation in an in vivo rat model.

Little is known about the internal mechanics of the in vivo spinal cord during injury. The objective of this study was to develop a method of tracking internal and surface deformation of in vivo rat spinal cord during compression using radiography. Since neural tissue is radio-translucent, radio-opaque markers were injected into the spinal cord. Two tantalum beads (260 µm) were injected into the cord (dorsal and ventral) at C5 of nine anesthetized rats. Four beads were glued to the lateral surface of the cord, caudal and cranial to the injection site. A compression plate was displaced 0.5 mm, 2 mm, and 3 mm into the spinal cord and lateral X-ray images were taken before, during, and after each compression for measuring bead displacements. Potential bead migration was monitored for by comparing displacements of the internal and glued surface beads. Dorsal beads moved significantly more than ventral beads with a range in averages of 0.57-0.71 mm and 0.31-0.35 mm respectively. Bead displacements during 0.5 mm compressions were significantly lower than 2 mm and 3 mm compressions. There was no statistically significant migration of the internal beads. The results indicate the merit of this technique for measuring in vivo spinal cord deformation. The pattern of bead displacements illustrates the complex internal and surface deformations of the spinal cord during transverse compression. This information is needed for validating physical and finite element spinal cord surrogates and to define relationships between loading parameters, internal cord deformation, and biological and functional outcomes.

On the Failure Initiation in the Proximal Human Femur Under Simulated Sideways Fall.

The limitations of areal bone mineral density measurements for identifying at-risk individuals have led to the development of alternative screening methods for hip fracture risk including the use of geometrical measurements from the proximal femur and subject specific finite element analysis (FEA) for predicting femoral strength, based on quantitative CT data (qCT). However, these methods need more development to gain widespread clinical applications. This study had three aims: To investigate whether proximal femur geometrical parameters correlate with obtained femur peak force during the impact testing; to examine whether or not failure of the proximal femur initiates in the cancellous (trabecular) bone; and finally, to examine whether or not surface fracture initiates in the places where holes perforate the cortex of the proximal femur. We found that cortical thickness around the trochanteric-fossa is significantly correlated to the peak force obtained from simulated sideways falling (R 2 = 0.69) more so than femoral neck cortical thickness (R 2 = 0.15). Dynamic macro level FE simulations predicted that fracture generally initiates in the cancellous bone compartments. Moreover, our micro level FEA results indicated that surface holes may be involved in primary failure events.

Material mapping strategy to improve the predicted response of the proximal femur to a sideways fall impact.

Sideways falls are largely responsible for the highly prevalent osteoporotic hip fractures in today's society. These injuries are dynamic events, therefore dynamic FE models validated with dynamic ex vivo experiments provide a more realistic simulation than simple quasi-static analysis. Drop tower experiments using cadaveric specimens were used to identify the material mapping strategy that provided the most realistic mechanical response under impact loading. The present study tested the addition of compression-tension asymmetry, tensile bone damage, and cortical-specific strain rate dependency to the material mapping strategy of fifteen dynamic FE models of the proximal femur, and found improved correlations and reduced error for whole bone stiffness (R2 = 0.54, RSME = 0.87kN/mm) and absolute maximum force (R2 = 0.56, RSME =0.57kN), and a high correlation in impulse response (R2 = 0.82, RSME =12.38kg/s). Simulations using fully bonded nodes between the rigid bottom plate and PMMA cap supporting the femoral head had higher correlations and less error than simulations using a frictionless sliding at this contact surface. Strain rates over 100/s were observed in certain elements in the femoral neck and trochanter, indicating that additional research is required to better quantify the strain rate dependencies of both trabecular and cortical bone at these strain rates. These results represent the current benchmark in dynamic FE modeling of the proximal femur in sideways falls. Future work should also investigate improvements in experimental validation techniques by developing better displacement measurements and by enhancing the biofidelity of the impact loading wherever possible.

Defining an Analytic Framework to Evaluate Quantitative MRI Markers of Traumatic Axonal Injury: Preliminary Results in a Mouse Closed Head Injury Model.

Diffuse axonal injury (DAI) is a hallmark of traumatic brain injury (TBI) pathology. Recently, the Closed Head Injury Model of Engineered Rotational Acceleration (CHIMERA) was developed to generate an experimental model of DAI in a mouse. The characterization of DAI using diffusion tensor magnetic resonance imaging (MRI; diffusion tensor imaging, DTI) may provide a useful set of outcome measures for preclinical and clinical studies. The objective of this study was to identify the complex neurobiological underpinnings of DTI features following DAI using a comprehensive and quantitative evaluation of DTI and histopathology in the CHIMERA mouse model. A consistent neuroanatomical pattern of pathology in specific white matter tracts was identified across ex vivo DTI maps and photomicrographs of histology. These observations were confirmed by voxelwise and regional analysis of DTI maps, demonstrating reduced fractional anisotropy (FA) in distinct regions such as the optic tract. Similar regions were identified by quantitative histology and exhibited axonal damage as well as robust gliosis. Additional analysis using a machine-learning algorithm was performed to identify regions and metrics important for injury classification in a manner free from potential user bias. This analysis found that diffusion metrics were able to identify injured brains almost with the same degree of accuracy as the histology metrics. Good agreement between regions detected as abnormal by histology and MRI was also found. The findings of this work elucidate the complexity of cellular changes that give rise to imaging abnormalities and provide a comprehensive and quantitative evaluation of the relative importance of DTI and histological measures to detect brain injury.

Morphology based anisotropic finite element models of the proximal femur validated with experimental data.

Finite element analysis (FEA) of bones scanned with Quantitative Computed Tomography (QCT) can improve early detection of osteoporosis. The accuracy of these models partially depends on the assigned material properties, but anisotropy of the trabecular bone cannot be fully captured due to insufficient resolution of QCT. The inclusion of anisotropy measured from high resolution peripheral QCT (HR-pQCT) could potentially improve QCT-based FEA of the femur, although no improvements have yet been demonstrated in previous experimental studies. This study analyzed the effects of adding anisotropy to clinical resolution femur models by constructing six sets of FE models (two isotropic and four anisotropic) for each specimen from a set of sixteen femurs that were experimentally tested in sideways fall loading with a strain gauge on the superior femoral neck. Two different modulus-density relationships were tested, both with and without anisotropy derived from mean intercept length analysis of HR-pQCT scans. Comparing iso- and anisotropic models to the experimental data resulted in nearly identical correlation and highly similar linear regressions for both whole bone stiffness and strain gauge measurements. Anisotropic models contained consistently greater principal compressive strains, approximately 14% in magnitude, in certain internal elements located in the femoral neck, greater trochanter, and femoral head. In summary, anisotropy had minimal impact on macroscopic measurements, but did alter internal strain behavior. This suggests that organ level QCT-based FE models measuring femoral stiffness have little to gain from the addition of anisotropy, but studies considering failure of internal structures should consider including anisotropy to their models.

The influence of the modulus-density relationship and the material mapping method on the simulated mechanical response of the proximal femur in side-ways fall loading configuration.

Contributing to slow advance of finite element (FE) simulations for hip fracture risk prediction, into clinical practice, could be a lack of consensus in the biomechanics community on how to map properties to the models. Thus, the aim of the present study was first, to systematically quantify the influence of the modulus-density relationship (E-ρ) and the material mapping method (MMM) on the predicted mechanical response of the proximal femur in a side-ways fall (SWF) loading configuration and second, to perform a model-to-model comparison of the predicted mechanical response within the femoral neck for all the specimens tested in the present study, using three different modelling techniques that have yielded good validation outcome in terms of surface strain prediction and whole bone response according to the literature. We found the outcome to be highly dependent on both the E-ρ relationship and the MMM. In addition, we found that the three modelling techniques that have resulted in good validation outcome in the literature yielded different principal strain prediction both on the surface as well as internally in the femoral neck region of the specimens modelled in the present study. We conclude that there exists a need to carry out a more comprehensive validation study for the SWF loading mode to identify which combination of MMMs and E-ρ relationship leads to the best match for whole bone and local mechanical response. The MMMs tested in the present study have been made publicly available at https://simtk.org/home/mitk-gem.

Injuries at the Whistler Sliding Center: a 4-year retrospective study.

BACKGROUND: The Whistler Sliding Centre (WSC) in British Columbia, Canada, has played host to many events including the 2010 Winter Olympics. This study was performed to better understand sliding sport incident (crash, coming off sled, etc) and injury prevalence and provide novel insights into the effect of slider experience and track-specific influences on injury risk and severity. METHODS: Track documentation and medical records over 4 years (2007 track inception to 2011) were used to form 3 databases, including over 43,200 runs (all sliding disciplines). Statistics were generated relating incident and injury to start location, crash location and slider experience as well as to understand injury characteristics. RESULTS: Overall injury rate was found to be 0.5%, with more severe injury occurring in <0.1% of the total number of runs. More frequent and severe injuries were observed at lower track locations. Of 2605 different sliders, 73.6% performed 1-29 runs down the track. Increased slider experience was generally found to reduce the frequency of injury. Lacerations, abrasions and contusions represented 52% of all injuries. A fatality represented the most severe injury on the track and was the result of track ejection. CONCLUSIONS: By investigating the influence of start location, incident location and slider experience on incident and injury frequency and severity, a better understanding has been achieved of the inherent risks involved in sliding sports. Incident monitoring, with particular focus on track ejection, should be an emphasis of sliding tracks.

Comparison of explicit finite element and mechanical simulation of the proximal femur during dynamic drop-tower testing.

Current screening techniques based on areal bone mineral density (aBMD) measurements are unable to identify the majority of people who sustain hip fractures. Biomechanical examination of such events may help determine what predisposes a hip to be susceptible to fracture. Recently, drop-tower simulations of in-vitro sideways falls have allowed the study of the mechanical response of the proximal human femur at realistic impact speeds. This technique has created an opportunity to validate explicit finite element (FE) models against dynamic test data. This study compared the outcomes of 15 human femoral specimens fractured using a drop tower with complementary specimen-specific explicit FE analysis. Correlation coefficient and root mean square error (RMSE) were found to be moderate for whole bone stiffness comparison (R(2)=0.3476 and 22.85% respectively). No correlation was found between experimentally and computationally predicted peak force, however, energy absorption comparison produced moderate correlation and RMSE (R(2)=0.4781 and 29.14% respectively). By comparing predicted strain maps to high speed video data we demonstrated the ability of the FE models to detect vulnerable portions of the bones. Based on our observations, we conclude that there exists a need to extend the current apparent level material models for bone to cover higher strain rates than previously tested experimentally.

Effects of hip abductor muscle forces and knee boundary conditions on femoral neck stresses during simulated falls.

UNLABELLED: Through experiments that simulated sideways falls with a mechanical hip impact simulator, we demonstrated the protective effect of hip abductor muscle forces in reducing peak stresses at the femoral neck and the corresponding risk for hip fracture. INTRODUCTION: Over 90% of hip fractures are due to falls, and an improved understanding the factors that separate injurious and non-injurious falls (via their influence on the peak stress generated at the femoral neck) may lead to improved risk assessment and prevention strategies. The purpose of this study was to measure the effect of muscle forces spanning the hip, and knee boundary conditions, on peak forces and estimated stresses at the femoral neck during simulated falls with a mechanical system. METHODS: We simulated hip abductor muscle forces and knee boundary conditions with a mechanical hip impact simulator and measured forces and stresses at the femoral neck during sideways falls. RESULTS: Peak compressive and tensile stresses, shear force, bending moment, and axial force are each associated with hip abductor muscle forces and knee boundary conditions (p < 0.0005). When muscle force increased from 400 to 1,200 N, peak compressive and tensile stresses decreased 24 and 56%, respectively. These effects were similar to the magnitude of decline in fracture strength associated with osteoporosis and arose from the tension-band effect of the muscle in reducing the bending moment by 37%. Furthermore, peak compressive and tensile stresses averaged 40 and 51% lower, respectively, in the free knee than fixed knee condition. CONCLUSIONS: Contraction of the hip abductor muscles at the moment of impact during a fall, and landing with the knee free of constraints, substantially reduced peak compressive and tensile stresses at the femoral neck and risk for femoral fracture in a sideways fall.

Proximal femur elastic behaviour is the same in impact and constant displacement rate fall simulation.

Understanding proximal femur fracture may yield new targets for fracture prevention screening and treatment. The goal of this study was to characterize force-displacement and failure behaviours in the proximal femur between displacement control and impact loading fall simulations. Twenty-one human proximal femurs were tested in two ways, first to a sub-failure load at a constant displacement rate, then to fracture in an impact fall simulator. Comparisons of sub-failure energy and stiffness were made between the tests at the same compressive force. Additionally, the impact failure tests were compared with previous, constant displacement rate failure tests (at 2 and 100mm/s) in terms of energy, yield force, and stiffness. Loading and displacement rates were characterized and related to specimen stiffness in the impact tests. No differences were observed between the sub-failure constant displacement and impact tests in the aforementioned metrics. Comparisons between failure tests showed that the impact group had the lowest absorbed energy, 24% lower maximum force and 160% higher stiffness than the 100mm/s group (p<0.01 for all), but suffered from low statistical power to differentiate the donor age and specimen BMD. Loading and displacement rates for the specimens tested using impact varied during each test and between specimens and did not show appreciable viscoelasticity. These results indicate that constant displacement rate testing may help understand sub-failure mechanical behaviour, but may not elucidate failure behaviours. The differences between the impact and constant displacement rate fall simulations have important ramifications for interpreting the results of previous experiments.

Development of a balanced experimental-computational approach to understanding the mechanics of proximal femur fractures.

The majority of people who sustain hip fractures after a fall to the side would not have been identified using current screening techniques such as areal bone mineral density. Identifying them, however, is essential so that appropriate pharmacological or lifestyle interventions can be implemented. A protocol, demonstrated on a single specimen, is introduced, comprising the following components; in vitro biofidelic drop tower testing of a proximal femur; high-speed image analysis through digital image correlation; detailed accounting of the energy present during the drop tower test; organ level finite element simulations of the drop tower test; micro level finite element simulations of critical volumes of interest in the trabecular bone. Fracture in the femoral specimen initiated in the superior part of the neck. Measured fracture load was 3760N, compared to 4871N predicted based on the finite element analysis. Digital image correlation showed compressive surface strains as high as 7.1% prior to fracture. Voxel level results were consistent with high-speed video data and helped identify hidden local structural weaknesses. We found using a drop tower test protocol that a femoral neck fracture can be created with a fall velocity and energy representative of a sideways fall from standing. Additionally, we found that the nested explicit finite element method used allowed us to identify local structural weaknesses associated with femur fracture initiation.

The effect of lateral eccentricity on failure loads, kinematics, and canal occlusions of the cervical spine in axial loading.

Current neck injury criteria do not include limits for lateral bending combined with axial compression and this has been observed as a clinically relevant mechanism, particularly for rollover motor vehicle crashes. The primary objectives of this study were to evaluate the effects of lateral eccentricity (the perpendicular distance from the axial force to the centre of the spine) on peak loads, kinematics, and spinal canal occlusions of subaxial cervical spine specimens tested in dynamic axial compression (0.5 m/s). Twelve 3-vertebra human cadaver cervical spine specimens were tested in two groups: low and high eccentricity with initial eccentricities of 1 and 150% of the lateral diameter of the vertebral body. Six-axis loads inferior to the specimen, kinematics of the superior-most vertebra, and spinal canal occlusions were measured. High speed video was collected and acoustic emission (AE) sensors were used to define the time of injury. The effects of eccentricity on peak loads, kinematics, and canal occlusions were evaluated using unpaired Student t-tests. The high eccentricity group had lower peak axial forces (1544 ± 629 vs. 4296 ± 1693 N), inferior displacements (0.2 ± 1.0 vs. 6.6 ± 2.0 mm), and canal occlusions (27 ± 5 vs. 53 ± 15%) and higher peak ipsilateral bending moments (53 ± 17 vs. 3 ± 18 Nm), ipsilateral bending rotations (22 ± 3 vs. 1 ± 2°), and ipsilateral displacements (4.5 ± 1.4 vs. -1.0 ± 1.3 mm, p<0.05 for all comparisons). These results provide new insights to develop prevention, recognition, and treatment strategies for compressive cervical spine injuries with lateral eccentricities.

Acoustic emission signals can discriminate between compressive bone fractures and tensile ligament injuries in the spine during dynamic loading.

Acoustic emission (AE) sensors are a reliable tool in detecting fracture; however they have not been used to differentiate between compressive osseous and tensile ligamentous failures in the spine. This study evaluated the effectiveness of AE data in detecting the time of injury of ligamentum flavum (LF) and vertebral body (VB) specimens tested in tension and compression, respectively, and in differentiating between these failures. AE signals were collected while LF (n=7) and VB (n=7) specimens from human cadavers were tested in tension and compression (0.4m/s), respectively. Times of injury (time of peak AE amplitude) were compared to those using traditional methods (VB: time of peak force, LF: visual evidence in high speed video). Peak AE signal amplitudes and frequencies (using Fourier and wavelet transformations) for the LF and VB specimens were compared. In each group, six specimens failed (VB, fracture; LF, periosteal stripping or attenuation) and one did not. Time of injury using AE signals for VB and LF specimens produced average absolute differences to traditional methods of 0.7 (SD=0.2) ms and 2.4 (SD=1.5) ms (representing 14% and 20% of the average loading time), respectively. AE signals from VB fractures had higher amplitudes and frequencies than those from LF failures (average peak amplitude 87.7 (SD=6.9) dB vs. 71.8 (SD=9.8)dB for the inferior sensor, p<0.05; median characteristic frequency from the inferior sensor 97 (interquartile range, IQR, 41) kHz vs. 31 (IQR 2) kHz, p<0.05). These findings demonstrate that AE signals could be used to delineate complex failures of the spine.

Cervical spinal cord deformation during simulated head-first impact injuries.

The relationship between bony spinal column and spinal cord injury during an injury event is not well understood. While several studies have measured spinal canal occlusion during axial impact, there has been limited work done to quantify the spinal cord compression or deformation during simulated injury. Because the cord is a viscoelastic solid it may provide resistance to bone fragments, ligaments or other elements that move into the canal and impinge it during column injury. This would differentiate the measurement of cord compression from the measurement of occlusion of an empty canal. In the present study, a novel method of visualizing and quantifying spinal cord deformation during dynamic head-first impact of ex vivo human cervical spine specimens (N=6) was developed. A radiodense, biofidelic surrogate spinal cord was imaged in the spinal canal using high speed cineradiography at 1000 frames per second. The dorsal-ventral diameter of the cord was measured at 1.5mm increments along its length for each frame of the radiographic footage. The resulting cord deformations were used to determine the theoretical neurological outcome of the impact based on published in vivo ferret studies. The corresponding probability of recovery for the spinal cord deformations in these tests ranged between 8% for atlantoaxial dislocation injury and 95% for mid-cervical spine hyperextension injury (based on the ferret data). Clinically relevant spinal column fracture patterns were produced in this study.

Hip protectors: recommendations for conducting clinical trials--an international consensus statement (part II).

INTRODUCTION: While hip protectors are effective in some clinical trials, many, including all in community settings, have been unable to demonstrate effectiveness. This is due partly to differences in the design and analysis. The aim of this report is to develop recommendations for subsequent clinical research. METHODS: In November of 2007, the International Hip Protector Research Group met to address barriers to the clinical effectiveness of hip protectors. This paper represents a consensus statement from the group on recommended methods for conducting future clinical trials of hip protectors. RESULTS AND CONCLUSIONS: Consensus recommendations include the following: the use of a hip protector that has undergone adequate biomechanical testing, the use of sham hip protectors, the conduct of clinical trials in populations with annual hip fracture incidence of at least 3%, a run-in period with demonstration of adequate adherence, surveillance of falls and adherence, and the inclusion of economic analyses. Larger and more costly clinical trials are required to definitively investigate effectiveness of hip protectors.

Hip protectors: recommendations for biomechanical testing--an international consensus statement (part I).

INTRODUCTION: Hip protectors represent a promising strategy for preventing fall-related hip fractures. However, clinical trials have yielded conflicting results due, in part, to lack of agreement on techniques for measuring and optimizing the biomechanical performance of hip protectors as a prerequisite to clinical trials. METHODS: In November 2007, the International Hip Protector Research Group met in Copenhagen to address barriers to the clinical effectiveness of hip protectors. This paper represents an evidence-based consensus statement from the group on recommended methods for evaluating the biomechanical performance of hip protectors. RESULTS AND CONCLUSIONS: The primary outcome of testing should be the percent reduction (compared with the unpadded condition) in peak value of the axial compressive force applied to the femoral neck during a simulated fall on the greater trochanter. To provide reasonable results, the test system should accurately simulate the pelvic anatomy, and the impact velocity (3.4 m/s), pelvic stiffness (acceptable range: 39-55 kN/m), and effective mass of the body (acceptable range: 22-33 kg) during impact. Given the current lack of clear evidence regarding the clinical efficacy of specific hip protectors, the primary value of biomechanical testing at present is to compare the protective value of different products, as opposed to rejecting or accepting specific devices for market use.