A distinctive release profile of vancomycin and tobramycin from a new and injectable polymeric dicalcium phosphate dehydrate cement (P-DCPD).

A novel injectable polymeric dicalcium phosphate dehydrate (P-DCPD) cement was developed with superior mechanical strength and excellent cohesion. The purpose of this study was to assess the in vitro performance of P-DCPD loaded with vancomycin (VAN-P), tobramycin (TOB-P) and combination of both (VAN/TOB-P) (10%, w/w). There is a distinctive release profile between VAN and TOB. VAN-P showed decreased initial burst (<30% within 3 d) and sustained VAN release (76% in 28 d). In the presence of TOB (VAN/TOB-P), >90% of VAN was released within 3 d (p < 0.05). Slow and limited TOB release was observed both in TOB-P (<5%) and in TOB/VAN-P (<1%) over 28 d. Zone of inhibition (ZOI) of Staphylococcus aureus growth showed that eluents collected from VAN-P had stronger and longer ZOI (28 d) than that from TOB-P (14 d, p < 0.05). Direct contact of VAN-P, TOB-P and VAN/TOB-P cements displayed persistent and strong ZOI for >3 weeks. Interestingly, the cement residues (28 d after drug release) still maintained strong ZOI ability. P-DCPD with or without antibiotics loading were nontoxic and had no inferior impacts on the growth of osteoblastic MC3T3 cells. VAN-P and TOB-P were injectable. No significant influence on setting time was observed in both VAN-P (11.7 ± 1.9 min) and VAN/TOB-P (10.8 ± 1.5 min) as compared to control (12.2 ± 2.6 min). We propose that a distinctive release profile of VAN and TOB observed is mainly due to different distribution pattern of VAN and TOB within P-DCPD matrix. A limited release of TOB might be due to the incorporation of TOB inside the crystalline lattice of P-DCPD crystals. Our data supported that the bactericidal efficacy of antibiotics-loaded P-DCPD is not only depend on the amount and velocity of antibiotics released, but also probably more on the direct contact of attached bacteria on the degrading cement surface.

Evaluating thoracolumbar spine response during simulated underbody blast impact using a total human body finite element model.

In a study of spine injuries in Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) from 2001-09, spinal fractures sustained by mounted soldiers accounted for 26% of all injuries, and of that, 43% were caused by explosions [1]. The thoracolumbar region is the most vulnerable area of the spine [2], and injuries are often incapacitating, making egress from vehicles difficult. Injury prediction from such events continues to remain a challenge due to the limited availability of studies specifically focused on underbody blasts (UBB) and criteria on related injuries. This study focuses on developing and validating the spine response of an updated 50th percentile male Global Human Body Models Consortium (GHBMC) Finite Element (FE) model using instrumented post-mortem human subject (PMHS) laboratory tests under two unique conditions. The model was validated against response corridors created using scaled thoracic (T12, T8, T5, T1) and sacrum (S1) spine Z-axis accelerations obtained from WSU whole-body PMHS tests. The scores for the updated spine model ranged from 0.557 - 0.756 for condition 1 (Seat- 4 m/s in 10 ms; Floor- 6 m/s in 5 ms) and 0.639-0.849 for condition 2 (Seat- 4 m/s in 55 ms; Floor- 8 m/s in 2 ms). The PMHS tests sustained spinal injuries in the thoracolumbar region. The validated model indicates high stress and strain concentrations at the same locations, providing an explanation for the fractures sustained in the PMHS tests.

Biofidelity assessment of the 6-year-old ATDs in lateral impact.

OBJECTIVES: The objective of this study was to assess and compare the current lateral impact biofidelity of the shoulder, thorax, abdomen, and pelvis of the Q6, Q6s, and Hybrid III (HIII) 6-year-old anthropomorphic test devices (ATDs) through lateral impact testing. METHODS: A series of lateral impact pendulum tests, vertical drop tests, and Wayne State University (WSU) sled tests was performed, based on the procedures detailed in ISO/TR 9790 (1999) and scaling to the 6-year-old using Irwin et al. ( 2002 ). The HIII used in this study was tested with the Ford-designed abdomen described in Rouhana ( 2006 ) and Elhagediab et al. ( 2006 ). The data collected from the 3 different ATDs were filtered using SAE J211 (SAE International 2003 ), aligned using the methodology described by Donnelly and Moorhouse ( 2012 ), and compared for each body region tested (shoulder, thorax, abdomen, and pelvis). The biofidelity performance in lateral impact for the 3 ATDs was assessed against the scaled biofidelity targets published in Irwin et al. ( 2002 ), the abdominal biofidelity target suggested in van Ratingen et al. ( 1997 ), and the biofidelity targets published in Rhule et al. ( 2013 ). Regional and overall biofidelity rankings for each of the 3 ATDs were performed using both the ISO 9790 biofidelity rating system (ISO/TR 9790 1999) and the NHTSA's external biofidelity ranking system (BRS; Rhule et al. 2013 ). RESULTS: All 3 6-year-old ATD's pelvises were rated as least biofidelic of the 4 body regions tested, based on both the ISO and BRS biofidelity rating systems, followed by the shoulder and abdomen, respectively. The thorax of all 3 ATDs was rated as the most biofidelic body region using the aforementioned biofidelity rating systems. The HIII 6-year-old ATD was rated last in overall biofidelity of the 3 tested ATDs, based on both rating systems. The Q6s ATD was rated as having the best overall biofidelity using both rating systems. CONCLUSIONS: All 3 ATDs are more biofidelic in the thorax and abdomen than the shoulder and pelvis, with the pelvis being the least biofidelic of all 4 tested body regions. None of the 3 tested 6-year-old ATDs had an overall ranking of 2.0 or less, based on the BRS ranking. Therefore, it is expected that none of the 3 ATDs would mechanically respond like a postmortem human subject (PMHS) in a lateral impact crash test based on this ranking system. With respect to the ISO biofidelity rating, the HIII dummy would be considered unsuitable and the Q-series dummies would be considered marginal for assessing side impact occupant protection.

A mechanism of injury to the forefoot in car crashes.

OBJECTIVE: The purpose of this study was to determine a mechanism of injury of the forefoot due to impact loads and accelerations as noted in some frontal offset car crashes. METHODS: The impact tests conducted simulated knee-leg-foot entrapment, floor pan intrusions, whole-body deceleration, muscle tension, and foot/pedal interaction. Specimens were impacted at speeds of up to 16 m/s. To verify this injury mechanism research was conducted in an effort to produce Lisfranc type injuries and metatarsal fractures. A total of 54 lower legs of post-mortem human subjects were tested. Two possible mechanisms of injury were investigated. For the first mechanism the driver was assumed to be braking hard with the foot on the brake pedal and at 0 deg plantar flexion (Plantar Nominal Configuration) and the brake pedal was in contact with the foot behind the ball of the foot. The second mechanism was studied by having the ball of the foot either on the brake pedal or on the floorboard with the foot plantar-flexed 35 to 50 deg (Plantar Flexed Configuration). RESULTS: The Plantar Nominal injury mechanism yielded few injuries of the type the study set out to produce. Out of 13 specimens tested at speeds of 16 m/s, three had injuries of the metatarsal (MT) and tarsometatarsal joints. The Plantar Flexed Configuration injury mechanism yielded 65% injuries at high (12.5-16 m/s) and moderate (6-12 m/s) speeds. CONCLUSION: It is concluded that Lisfranc type foot injuries are the result of impacting the forefoot in the Plantar Flexed Configuration. The injuries were consistent with those reported by physicians treating accident victims and were verified by an orthopedic surgeon during post impact x-ray and autopsy. They included Lisfranc fractures, ligamentous disruptions, and metatarsal fractures.

Prediction of bone strength in growing animals using noninvasive bone mass measurements.

This study aims to test the hypothesis that noninvasive bone mass measurements can be used to predict bone strength in a piglet model. Dual energy X-ray absorptiometry measurements of bone mineral content (BMC), bone mineral density (BMD), and bone area (BA) were obtained from four sets of bones (left and right humeri and femora) of 12 piglets (6-68 days and 2250-17660 g). Bone strength, defined by the energy to bone failure, fracture moment, and flexural rigidity, was determined from three point bending tests using an Instron material testing system. Results show that bone mass between left and right extremities was highly correlated (r = 0.96 to 0.99, P < or 0.001 all comparisons) and was similar for bone strength (r = 0.85 to 0.98, P < 0.01 all comparisons). However, based on the standard deviation of the difference between measurements from left and right extremities, the agreement sides was better for bone mass than for bone strength measurements (r = 0.68-0.99, P < = 0.05-< or = 0.001). The predictive ability of bone mass on bone strength varied (adjusted r2 = 0.41-0.97) depending on the bone tested and the measurement parameter used, although remained statistically significant in all instances (P < 0.05-< or = 0.001). We conclude that the developing organisms, noninvasive bone mass measurements are correlated with and predictive of bone strength, although bones from the same side and same anatomical site should be used for comparison purposes.

Lower Limb: Advanced FE Model and New Experimental Data.

The Lower Limb Model for Safety (LLMS) is a finite element model of the lower limb developed mainly for safety applications. It is based on a detailed description of the lower limb anatomy derived from CT and MRI scans collected on a subject close to a 50th percentile male. The main anatomical structures from ankle to hip (excluding the hip) were all modeled with deformable elements. The modeling of the foot and ankle region was based on a previous model Beillas et al. (1999) that has been modified. The global validation of the LLMS focused on the response of the isolated lower leg to axial loading, the response of the isolated knee to frontal and lateral impact, and the interaction of the whole model with a Hybrid III model in a sled environment, for a total of nine different set-ups. In order to better characterize the axial behavior of the lower leg, experiments conducted on cadaveric tibia and foot were reanalyzed and experimental corridors were proposed. Future work will include additional validation of the model using global data, joint kinematics data, and deformation data at the local level.

Qualitative analysis of neck kinematics during low-speed rear-end impact.

OBJECTIVE: To analyze neck kinematics and loading patterns during rear-end impacts. DESIGN: The motion of each cervical vertebra was captured using a 250 frame/s X-ray system during a whole body rear-end impact. These data were analyzed in order to understand different phases of neck loading during rear-end impact. BACKGROUND: The mechanism of whiplash injury remains largely unknown. An understanding of the underlying kinematics of whiplash is crucial to the identification of possible injury mechanisms before countermeasures can be designed. METHODS: Metallic markers were inserted into the vertebral bodies and spinous processes of each of the seven cervical vertebrae. Relative displacement-time traces between each pair of adjacent cervical vertebrae were calculated from X-ray data. Qualitative analyses of the kinematics of the neck at different phase of impact were performed. RESULTS: The neck experiences compression, tension, shear, flexion and extension at different cervical levels and/or during different stages of the whiplash event. CONCLUSIONS: Neck kinematics during whiplash is rather complicated and greatly influenced by the rotation of the thoracic spine, which occurs as a result of the straightening of the kyphotic thoracic curvature. RELEVANCE: Understanding the complicated kinematics of a rear-end impact may help clinicians and researchers shed some light on potential mechanisms of whiplash neck injury.

Kinematics of human cadaver cervical spine during low speed rear-end impacts.

The purposes of this study were to measure the relative linear and angular displacements of each pair of adjacent cervical vertebrae and to compute changes in distance between two adjacent facet joint landmarks during low posterior-anterior (+Gx) acceleration without significant hyperextension of the head. A total of twentysix low speed rear-end impacts were conducted using six postmortem human specimens. Each cadaver was instrumented with two to three neck targets embedded in each cervical vertebra and nine accelerometers on the head. Sequential x-ray images were collected and analyzed. Two seatback orientations were studied. In the global coordinate system, the head, the cervical vertebrae, and the first or second thoracic vertebra (T1 or T2) were in extension during rear-end impacts. The head showed less extension in comparison with the cervical spine. Relative motion for each cervical motion segment went from flexion at the upper cervical levels to extension at the lower cervical levels, with a transition region at the mid-cervical levels. This rotational pattern formed an "S" shape in the cervical spine during the initial phase of low-speed rear impacts. A pair of facet joint landmarks on each cervical motion segment was used to measure the distance across the joint space. Uni-axial facet capsular strains were calculated by dividing changes in this distance over the original distance in seven tests using three specimens. In 20-degree seatback tests, the average strain was 32+/-11% for the C2/C3 facet joint (17%-43% range), and 59+/-26% for the C3/C4 facet joint (41%-97% range). The C4/C5 and C5/C6 facet joints exhibited peak tensile or compressive strains in different specimens. In 0-degree seatback tests, the average strain was 28+/-11% for the C2/C3 facet joint (21%-41% range), 30+/-9% for the C3/C4 facet joint (21%-39% range), 22+/-4% for the C4/C5 facet joint (19%-25% range), and 60+/-13% for the C5/C6 facet joint (51%-69% range). In 20-degree seatback tests, there was less initial cervical lordosis, more upward ramping of the thoracic spine, and more relative rotation of each cervical motion segment in comparison with the 0-degree seatback tests. Relative to T1, the head went from flexion to extension for 20-degree seatback tests while stayed in extension for 0-degree seatback tests.

Development of a finite element model of the human shoulder.

Previous studies have hypothesized that the shoulder may be used to absorb some impact energy and reduce chest injury due to side impacts. Before this hypothesis can be tested, a good understanding of the injury mechanisms and the kinematics of the shoulder is critical for occupant protection in side impact. However, existing crash dummies and numerical models are not designed to reproduce the kinematics and kinetics of the human shoulder. The purpose of this study was to develop a finite element model of the human shoulder in order to achieve a deeper understanding of the injury mechanisms and the kinematics of the shoulder in side impact. Basic anthropometric data of the human shoulder used to develop the skeletal and muscular portions of this model were taken from commercial data packages. The shoulder model included three bones (the humerus, scapula and clavicle) and major ligaments and muscles around the shoulder. This model was then integrated into a human thorax model developed at Wayne State University (WSU) along with pre-existing models of other body parts such as the pelvis and the lower extremities. Material properties used for the model were taken from the literature. The model was first used to simulate lateral shoulder impact study by the Association Peugeot- Renault (APR) followed by simulations of several of the 17 rigid and padded cadaveric impacts conducted on a side impact sled at WSU. Contact forces measured at the levels of shoulder, thorax, abdomen and pelvis were used as response variables to validate the model. Additionally, a cadaveric test involving the deployment of a generic side airbag was also used to check the validity of the model. Model prediction of accelerations of the shoulder matched well against those measured experimentally. The role of the shoulder in side impact protection and the reduction of injury to the ribcage are discussed, based on model results.

Forces, moments, and acceleration acting on a restrained dummy during simulation of three possible accidents involving a wheelchair negotiating a curb: comparison between lap belt and four-point belt.

The objective of this study was to determine the effect of two types of restraining belts (lap belt and a four-point belt) on an instrumented dummy during three situations: wheelchair hitting straight into curb (SIC); wheelchair falling straight off a curb (SOC); wheelchair falling diagonally off a curb (DOC). A fully instrumented (50th percentile Hybrid III) dummy was seated in a standard wheelchair and restrained with one of the belts. The wheelchair rolled down a ramp reaching a platform at 2.4 miles per hour (comfortable walking speed). Three types of experiments were performed: SIC, SOC, DOC. Each experiment was repeated at least three times. Forces, moments, and acceleration were monitored and recorded via 48 sensors placed at the head, spine, and limbs. All experiments were videotaped and photographed. The data were averaged and compared with standards that have been previously established in car crash testing and with data recently obtained in a similar study using a nonrestrained dummy. Our results showed that in the SIC experiments, low magnitude forces, moments, and acceleration of no clinical significance were recorded with both types of belts. The wheelchair remained upright and the dummy safely seated. In the SOC experiments, the two belts prevented the dummy's ejection from the chair and, thus, have been effective in lowering the forces, moments, and acceleration and preventing significant injuries to the head and neck regions. In the DOC experiments, the lap belt proved to be somewhat more effective than the four-point belt in lowering the extension forces at the upper neck and the moments at the lower neck below injury levels. It also kept the head injury criteria well below injury level. We postulate that the four-point belt was less effective because of its more extensive body fixation, which leads to concentration of moments and forces at the head and lower neck regions. The results of this study show that restraining systems can enhance the safety of wheelchair occupants in certain incidents. It has been demonstrated that the lap belt is as effective as the four-point belt system in SIC and SOC incidents. In DOC falls, neither belt could prevent falls and trauma to the head and neck region. The lap belt, however, was somewhat superior. We recommend that wheelchairs be equipped with a lap belt and patients be encouraged to buckle-up while using the wheelchair outdoors.

Forces, moments, and accelerations acting on an unrestrained dummy during simulations of three wheelchair accidents.

To determine the magnitude and distribution of the forces, moments, and accelerations acting on an individual sitting in a wheelchair during three possible accidents occurring while negotiating a sidewalk curb, experimental trials were performed in a bioengineering laboratory using a 50th percentile Hybrid III dummy seated in a standard wheelchair. A ramp was designed with an adjustable incline to allow the wheelchair to reach the edge of a sidewalk height platform at the desired forward speed of 2.5 miles per hour (comfortable walking speed). The wheelchair velocity was monitored via an optical pickup. Three types of accidents were simulated: (1) a wheelchair hitting straight into a curb; (2) a wheelchair falling forward straight off a curb; (3) a wheelchair falling diagonally off a curb. Each experiment was repeated three times. Each run was photographed using high-speed cameras and videotaped from three perspectives: frontal, lateral, and overhead. The results were averaged and compared with published injury Assessment Values (IAV) and Head Injury Criteria (HIC). Of significance were the following results. In the straight into a curb experiments, the wheelchair remained upright and the dummy seated. Low magnitude forces (23-73 N), moments (1-12 Nm), and accelerations (0.2-1 G) were recorded at the neck and head. The HIC was low at 0.3. These results were of no clinical significance. In the straight off a curb experiments, properly attached footrests prevented the wheelchair from toppling over but did not prevent the dummy from falling off the wheelchair. Forces (187-4,176 N), moments (3-178 Nm), and accelerations (131-206 G) of great magnitude were recorded at the head and neck when the dummy fell off the wheelchair. These values were above IAV. The HIC was 960. In the diagonally off a curb experiments, both the wheelchair and the dummy fell sideways. High-magnitude forces (274-2,313 N), moments (4-110 Nm), and acceleration (140-236 G) were recorded in the head and neck regions. The HIC was 975. These values were close to IAV and may signify potential serious injuries.

Biomechanics of the human chest, abdomen, and pelvis in lateral impact.

Fourteen unembalmed cadavers were subjected to 44 blunt lateral impacts at velocities of approximately 4.5, 6.7, or 9.4 m/s with a 15 cm flat circular interface on a 23.4 kg pendulum accelerated to impact speed by a pneumatic impactor. Chest and abdominal injuries consisted primarily of rib fractures, with a few cases of lung or liver laceration in the highest severity impacts. There were two cases of pubic ramus fracture in the pelvic impacts. Logist analysis of the biomechanical responses and injury indicated that the maximum Viscous response had a slightly better correlation with injury than maximum compression for chest and abdominal impacts. A tolerance level of VC = 1.47 m/s for the chest and VC = 1.98 m/s for the abdomen were determined for a 25% probability of critical injury. Maximum compression was similarly set at C = 38% for the chest and at C = 44% for the abdomen. The experiments indicate that chest and abdominal injury may occur by a viscous mechanism during the rapid phase of body compression, and that the Viscous and compression responses are effective, complementary measures of injury risk in side impact. Although serious pelvic injury was infrequent, lateral public ramus fracture correlated with compression of the pelvis, not impact force or pelvic acceleration. Pelvic tolerance was set at 27% compression.

The effects of filling experimental large cortical defects with methylmethacrylate.

Three studies were performed using paired cadaver femurs to determine the effectiveness of filling large lytic defects of the femur with methylmethacrylate. In the first test, the paired femurs were prepared with a 2.5 cm defect in the femoral cortex. One of the paired femur defects was then filled with methylmethacrylate, while the other femur was left unfilled. The femurs were then tested in axial loading until failure. In the second test the paired femurs were prepared in the same manner and tested in torque until failure. In the third test, one of the paired femurs was prepared with a 2.5 cm defect and filled with methylmethacrylate while the other femur was left intact. When comparing those femurs whose defect was filled with methylmethacrylate to the prepared femurs that remained untreated, a significant increase in axial load strength of approximately 50% and an increase in torque strength of approximately 70% was found. It would seem that filling large lytic defects with methylmethacrylate at the time of internal fixation would significantly increase strength in both axial and torsional loadings.