Nicolas Graf

Preliminary Investigations on Intradiscal Pressures during Daily Activities: An In Vivo Study Using the Merino Sheep

Purpose Currently, no studies exist, which attest the suitability of the ovine intervertebral disc as a biomechanical in vivo model for preclinical tests of new therapeutic strategies of the human disc. By measuring the intradiscal pressure in vivo, the current study attempts to characterize an essential biomechanical parameter to provide a more comprehensive physiological understanding of the ovine intervertebral disc. Methods Intradiscal pressure (IDP) was measured for 24 hours within the discs L2-L3 and L4-L5 via a piezo-resistive pressure sensor in one merino sheep. The data were divided into an activity and a recovery phase and the corresponding average pressures for both phases were determined. Additionally, IDPs for different static and dynamic activities were analyzed and juxtaposed to human data published previously. After sacrificing the sheep, the forces corresponding to the measured IDPs were examined ex vivo in an axial compression test. Results The temporal patterns of IDP where pressure decreased during activity and increased during rest were comparable between humans and sheep. However, large differences were observed for different dynamic activities such as standing up or walking. Here, IDPs averaged 3.73 MPa and 1.60 MPa respectively, approximately two to four times higher in the ovine disc compared to human. These IDPs correspond to lower ex vivo derived axial compressive forces for the ovine disc in comparison to the human disc. For activity and rest, average ovine forces were 130 N and 58 N, compared to human forces of 400-600 N and 100 N, respectively. Conclusions In vivo IDPs were found to be higher in the ovine than in the human disc. In contrast, axial forces derived ex vivo were markedly lower in comparison to humans. Both should be considered in future preclinical tests of intradiscal therapies using the sheep. The techniques used in the current study may serve as a protocol for measuring IDP in a variety of large animal models.

Can prevention of a reherniation be investigated? Establishment of a herniation model and experiments with an anular closure device.

Study Design. Biomechanical in vitro study. Objective. To establish a reliable in vitro herniation model with human cadaver spines that enables evaluation of anular closure devices. Summary of Background Data. Biomechanically, it is desirable to close anulus defects after disc herniation to preserve as much nucleus as possible. Multiple anular closure options exist to prevent reherniation. A reliable test procedure is needed to evaluate the efficacy and reliability of these implants. Methods. Two groups of human lumbar segments (n = 6 per group) were tested under cyclic loading until herniation occurred or 100,000 load cycles were applied. One group contained moderate/severe degenerated discs. A second group had mild degenerated discs. Intradiscal pressure was measured in the intact state to confirm disc quality. If herniation occurred, the extruded material was reinserted into the disc and the anulus defect was treated with the Barricaid anular closure device (Intrinsic Therapeutics, Inc., Woburn, MA). Disc height and 3-dimensional flexibility of the specimens in the intact, defect, and implanted states were measured under pure moments in each principal motion plane. Afterwards, provocation of reherniation was attempted with additional 100,000 load cycles. Results. Likelihood of herniation was strongly linked to disc degeneration and supported by the magnitude of intradiscal pressure. In moderate/severe degenerated discs, only 1 herniation was created. In mild degenerated discs, herniations were reliably created in all specimens. Using this worst-case model, herniation caused a significant reduction of disc height, which was nearly restored with the implant. In no case was reherniation or implant migration visible after 100,000 load cycles after Barricaid implantation. Conclusion. We established a human herniation model that reliably produced nucleus extrusion during cyclic loading by selecting specimens with low disc degeneration. The Barricaid seems to prevent nucleus from reherniating. The reliability of this method suggests the opportunity to investigate other anulus closure devices and nucleus replacement techniques critically.

A new approach to prevent contralateral hip fracture: Evaluation of the effectiveness of a fracture preventing implant

BACKGROUND Among the millions of people suffering from a hip fracture each year, 20% may sustain a contralateral hip fracture within 5 years with an associated mortality risk increase reaching 64% in the 5 following years. In this context, we performed a biomechanical study to assess the performance of a hip fracture preventing implant. METHODS The implant consists of two interlocking peek rods unified with surgical cement. Numerical and biomechanical tests were performed to simulate single stance load or lateral fall. Seven pairs of femurs were selected from elderly subjects suffering from osteoporosis or osteopenia, and tested ex-vivo after implantation of the device on one side. FINDINGS The best position for the implant was identified by numerical simulations. The loadings until failure showed that the insertion of the implant increased significantly (P<0.05) both fracture load (+18%) and energy to fracture (+32%) of the implanted femurs in comparison with the intraindividual controls. The instrumented femur resisted the implementation of the non-instrumented femur fracture load for 30 cycles and kept its performance at the end of the cyclic loading. INTERPRETATION Implantation of the fracture preventing device improved both fracture load and energy to fracture when compared with intraindividual controls. This is consistent with previous biomechanical side-impact testing on pairs of femur using the same methodology. Implant insertion seems to be relevant to support multiple falls and thus, to prevent a second hip fracture in elderly patients.

Posterior motion preserving implants evaluated by means of intervertebral disc bulging and annular fiber strains

BACKGROUND The aims of motion preserving implants are to ensure sufficient stability to the spine, to release facet joints by also allowing a physiological loading to the intervertebral disc. The aim of this study was to assess disc load contribution by means of annular fiber strains and disc bulging of intact and stiffened segments. This was compared to the segments treated with various motion preserving implants. METHODS A laser scanning device was used to obtain three-dimensional disc bulging and annular fiber strains of six lumbar intervertebral discs (L2-3). Specimens were loaded with 500N or 7.5Nm moments in a spine tester. Each specimen was treated with four different implants; DSS™, internal fixator, Coflex™, and TOPS™. FINDINGS In axial compression, all implants performed in a similar way. In flexion, the Coflex decreased range of motion by 13%, whereas bulging and fiber strains were similar to intact. The DSS stabilized segments by 54% compared to intact. TOPS showed a slight decrease in fiber strains (5%) with a range of motion similar to intact. The rigid fixator allowed strains up to 2%. In lateral bending, TOPS yielded range of motion values similar to intact, but maximum fiber strains doubled from 6.5% (intact) to 13.8%. Coflex showed range of motion, bulging and strain values similar to intact. The DSS and the rigid fixator reduced these values. The implants produced only minor changes in axial rotation. INTERPRETATION This study introduces an in vitro method, which was employed to evaluate spinal implants other than standard biomechanical methods. We could demonstrate that dynamic stabilization methods are able to keep fiber strains and disc bulging in a physiological range.

Development of a scoliotic spine model for biomechanical in vitro studies

BACKGROUND In vitro experiments are important to compare surgical treatments. Especially new implants need preclinical evaluation. However, in vitro experiments with scoliotic specimens are impossible because they are not available. The purpose of this study was to develop an in vitro scoliosis model with cadaveric calf spine specimens, which may serve as a surrogate for human scoliotic spines. METHODS Six cadaveric calf spine specimens (T8-L6) were modified in three different steps to create a thoracolumbar scoliosis, convex to the right. First, all intervertebral discs received a nucleotomy. In the second step the cavity was filled with silicone. The silicone hardened in a bend position to obtain an asymmetrical nucleus. Finally, a wedge profile of the vertebral bodies was achieved by unilateral horizontal cuts (T9-L5), followed by spreading and fixation. Flexibility tests in a spine tester were performed in all motion planes with the original spine and after the different steps during the creation of the model. FINDINGS A Cobb angle >40° in the frontal plane could be achieved. Additionally, the vertebrae showed an axial rotation to the convex side. The range of motion increased due to the nucleotomy, decreased slightly after replacement with silicone, and decreased below the values of the intact spine after producing the wedge shape of the vertebrae. In each loading direction there was no significant asymmetry in the motion behavior. INTERPRETATION This study suggests a method to modify a straight spine specimen into a scoliotic one, which can be used for biomechanical in vitro experiments.

The rib cage stabilizes the human thoracic spine: An in vitro study using stepwise reduction of rib cage structures

The stabilizing effect of the rib cage on the human thoracic spine is still not sufficiently analyzed. For a better understanding of this effect as well as the calibration and validation of numerical models of the thoracic spine, experimental biomechanics data is required. This study aimed to determine (1) the stabilizing effect of the single rib cage structures on the human thoracic spine as well as the effect of the rib cage on (2) the flexibility of the single motion segments and (3) coupled motion behavior of the thoracic spine. Six human thoracic spine specimens including the entire rib cage were loaded quasi-statically with pure moments of ± 2 Nm in flexion/extension (FE), lateral bending (LB), and axial rotation (AR) using a custom-built spine tester. Motion analysis was performed using an optical motion tracking system during load application to determine range of motion (ROM) and neutral zone (NZ). Specimens were tested (1) in intact condition, (2) after removal of the intercostal muscles, (3) after median sternotomy, after removal of (4) the anterior rib cage up to the rib stumps, (5) the right sixth to eighth rib head, and (6) all rib heads. Significant (p < 0.05) increases of the ROM were found after dissecting the intercostal muscles (LB: + 22.4%, AR: + 22.6%), the anterior part of the rib cage (FE: + 21.1%, LB: + 10.9%, AR: + 72.5%), and all rib heads (AR: + 5.8%) relative to its previous condition. Compared to the intact condition, ROM and NZ increased significantly after removing the anterior part of the rib cage (FE: + 52.2%, + 45.6%; LB: + 42.0%, + 54.0%; AR: + 94.4%, + 187.8%). Median sternotomy (FE: + 11.9%, AR: + 21.9%) and partial costovertebral release (AR: + 11.7%) significantly increased the ROM relative to its previous condition. Removing the entire rib cage increased both monosegmental and coupled motion ROM, but did not alter the qualitative motion behavior. The rib cage has a strong effect on thoracic spine rigidity, especially in axial rotation by a factor of more than two, and should therefore be considered in clinical scenarios, in vitro, and in silico.

In vitro validation of a novel mechanical model for testing the anchorage capacity of pedicle screws using physiological load application

Biomechanical in vitro tests analysing screw loosening often include high standard deviations caused by high variabilities in bone mineral density and pedicle geometry, whereas standardized mechanical models made of PU foam often do not integrate anatomical or physiological boundary conditions. The purpose of this study was to develop a most realistic mechanical model for the standardized and reproducible testing of pedicle screws regarding the resistance against screw loosening and the holding force as well as to validate this model by in vitro experiments. The novel mechanical testing model represents all anatomical structures of a human vertebra and is consisting of PU foam to simulate cancellous bone, as well as a novel pedicle model made of short carbon fibre filled epoxy. Six monoaxial cannulated pedicle screws (Ø6.5 × 45mm) were tested using the mechanical testing model as well as human vertebra specimens by applying complex physiological cyclic loading (shear, tension, and bending; 5Hz testing frequency; sinusoidal pulsating forces) in a dynamic materials testing machine with stepwise increasing load after each 50.000 cycles (100.0N shear force + 20.0N per step, 51.0N tension force + 10.2N per step, 4.2Nm bending moment + 0.8Nm per step) until screw loosening was detected. The pedicle screw head was fixed on a firmly clamped rod while the load was applied in the vertebral body. For the in vitro experiments, six human lumbar vertebrae (L1-3, BMD 75.4 ± 4.0mg/cc HA, pedicle width 9.8 ± 0.6mm) were tested after implanting pedicle screws under X-ray control. Relative motions of pedicle screw, specimen fixture, and rod fixture were detected using an optical motion tracking system. Translational motions of the mechanical testing model experiments in the point of load introduction (0.9-2.2mm at 240N shear force) were reproducible within the variation range of the in vitro experiments (0.6-3.5mm at 240N shear force). Screw loosening occurred continuously in each case between 140N and 280N, while abrupt failures of the specimen were observed only in vitro. In the mechanical testing model, no translational motion was detected in the screw entry point, while in vitro, translational motions of up to 2.5mm in inferior direction were found, leading to a slight shift of the centre of rotation towards the screw tip. Translational motions of the screw tip of about 5mm in superior direction were observed both in vitro and in the mechanical testing model, while they were continuous in the mechanical testing model and rapidly increasing after screw loosening initiation in vitro. The overall pedicle screw loosening characteristics were qualitatively and quantitatively similar between the mechanical testing model and the human vertebral specimens as long as there was no translation of the screw at the screw entrance point. Therefore, the novel mechanical testing model represents a promising method for the standardized testing of pedicle screws regarding screw loosening for cases where the screw rotates around a point close to the screw entry point.

Biomechanical in vitro comparison of radiofrequency kyphoplasty and balloon kyphoplasty

PurposeBalloon kyphoplasty (BK) has emerged as a popular method for treating osteoporosis vertebral compression fractures (OVCFs). In response to several shortcomings of BK, alternative methods have been introduced, among which is radiofrequency kyphoplasty (RFK). Biomechanical comparisons of BK and RFK are very sparse. The purpose of this study was to perform a biomechanical study in which BK and RFK are compared.MethodsEach of the two study groups comprised six specimens prepared from two functional spinal units (FSUs) cut from fresh-frozen cadaveric spines (3 of T9–T11 and 3 of T12–L2). VCFs (A1.2 type) were created in the middle VB of each of the FSUs, with a height loss of 30% of the VB. After that, the specimens were subjected to cyclic compression–compression loading. The following parameters were determined: range of motion (ROM), height of the middle VB, augmentation time, cement interdigitation and cement distribution. Also, the cement layer, the trabecular bone in the augmented VB and the bone–cement interface were examined for cracks. All of these parameters were determined at various stages, namely in the intact middle VB and after its fracture, cement augmentation and subject to the cyclic loading protocol.ResultsFractures caused a significant increase in median ROM and a significant reduction in the height of fractured VB. Cement augmentation significantly stabilized the fractures and led to partial height restoration. ROM and vertebral height, however, were not restored to the intact levels. Cyclic loading led to a further significant increase in ROM and a significant height reduction. There were no significant differences between BK and RFK in terms of any of these parameters.ConclusionsBK and RFK achieved similar results for fracture stabilization and restoration of the height of the fractured VB. RFK involved shorter cement augmentation time and less damage to the trabecular bone.

The effect of follower load on the intersegmental coupled motion characteristics of the human thoracic spine: An in vitro study using entire rib cage specimens

The mechanical coupling behaviour of the thoracic spine is still not fully understood. For the validation of numerical models of the thoracic spine, however, the coupled motions within the single spinal segments are of importance to achieve high model accuracy. In the present study, eight fresh frozen human thoracic spinal specimens (C7-L1, mean age 54 ± 6 years) including the intact rib cage were loaded with pure bending moments of 5 Nm in flexion/extension (FE), lateral bending (LB), and axial rotation (AR) with and without a follower load of 400 N. During loading, the relative motions of each vertebra were monitored. Follower load decreased the overall ROM (T1-T12) significantly (p < 0.01) in all primary motion directions (extension: -46%, left LB: -72%, right LB: -72%, left AR: -26%, right AR: -26%) except flexion (-36%). Substantial coupled motion was found in lateral bending with ipsilateral axial rotation, which increased after a follower load was applied, leading to a dominant axial rotation during primary lateral bending, while all other coupled motions in the different motion directions were reduced under follower load. On the monosegmental level, the follower load especially reduced the ROM of the upper thoracic spine from T1-T2 to T4-T5 in all motion directions and the ROM of the lower thoracic spine from T9-T10 to T11-T12 in primary lateral bending. The facet joints, intervertebral disc morphologies, and the sagittal curvature presumably affect the thoracic spinal coupled motions depending on axial compressive preloading. Using these results, the validation of numerical models can be performed more accurately.