Effects of surgical joint destabilization on load sharing between ligamentous structures in the thoracic spine : a finite element investigation

Background: In vitro investigations have demonstrated the importance of the ribcage in stabilising the thoracic spine. Surgical alterations of the ribcage may change load-sharing patterns in the thoracic spine. Computer models are used in this study to explore the effect of surgical disruption of the rib-vertebrae connections on ligament load-sharing in the thoracic spine. Methods: A finite element model of a T7-8 motion segment, including the T8 rib, was developed using CT-derived spinal anatomy for the Visible Woman. Both the intact motion segment and the motion segment with four successive stages of destabilization (discectomy and removal of right costovertebral joint, right costotransverse joint and left costovertebral joint) were analysed for a 2000Nmm moment in flexion/extension, lateral bending and axial rotation. Joint rotational moments were compared with existing in vitro data and a detailed investigation of the load sharing between the posterior ligaments carried out. Findings: The simulated motion segment demonstrated acceptable agreement with in vitro data at all stages of destabilization. Under lateral bending and axial rotation, the costovertebral joints were of critical importance in resisting applied moments. In comparison to the intact joint, anterior destabilization increases the total moment contributed by the posterior ligaments. Interpretation: Surgical removal of the costovertebral joints may lead to excessive rotational motion in a spinal joint, increasing the risk of overload and damage to the remaining ligaments. The findings of this study are particularly relevant for surgical procedures involving rib head resection, such as some techniques for scoliosis deformity correction.

Towards determining soft tissue properties for modelling spine surgery : current progress and challenges

Current complication rates for adolescent scoliosis surgery necessitate the development of better surgical planning tools to improve outcomes. Here we present our approach to developing finite element models of the thoracolumbar spine for deformity surgery simulation, with patient-specific model anatomy based on low-dose pre-operative computed tomography scans. In a first step towards defining patient-specific tissue properties, an initial 'benchmark' set of properties were used to simulate a clinically performed pre-operative spinal flexibility assessment, the fulcrum bending radiograph. Clinical data for ten patients were compared with the simulated results for this assessment and in cases where these data differed by more than 10%, soft tissue properties for the costo-vertebral joint (CVJt) were altered to achieve better agreement. Results from these analyses showed that changing the CVJt stiffness resulted in acceptable agreement between clinical and simulated flexibility in two of the six cases. In light of these results and those of our previous studies in this area, it is suggested that spinal flexibility in the fulcrum bending test is not governed by any single soft tissue structure acting in isolation. More detailed biomechanical characterisation of the fulcrum bending test is required to provide better data for determination of patient-specific soft tissue properties.

Polycaprolactone-based scaffold plus recombinant human bone morphogenic protein rhBMP-2) in a sheep thoracic spine fusion model

Adolescent idiopathic scoliosis is a complex three dimensional deformity affecting 2-3% of the general population. The resulting spinal deformity consists of coronal curvature, hypokyphosis of the thoracic spine and vertebral rotation in the axial plane with posterior elements turned into the curve concavity. The potential for curve progression is heightened during the adolescent growth spurt. Success of scoliosis deformity correction depends on solid bony fusion between adjacent vertebrae after the intervertebral (IV) discs have been surgically cleared and the disc spaces filled with graft material. Recently a bioactive and resorbable scaffold fabricated from medical grade polycaprolactone has been developed for bone regeneration at load bearing sites. Combined with rhBMP-2, this has been shown to be successful in acting as a bone graft substitute in a porcine lumbar interbody fusion model when compared to autologous bone graft alone. The study aimed to establish a large animal thoracic spine interbody fusion model, develop spine biodegradable scaffolds (PCL) in combination with biologics (rhBMP-2) and to establish a platform for research into spine tissue engineering constructs. Preliminary results demonstrate higher grades of radiologically evident bony fusion across all levels when comparing fusion scores between the 3 and 6 month postop groups at the PCL CaP coated scaffold level, which is observed to be a similar grade to autograft, while no fusion is seen at the scaffold only level. Results to date suggest that the combination of rhBMP-2 and scaffold engineering actively promotes bone formation, laying the basis of a viable tissue engineered constructs.

Biomechanical performance of polycaprolactone (PCL)-based scaffold with rhBMP-2 in a sheep thoracic spine fusion model

Adolescent idiopathic scoliosis is a complex three dimensional deformity affecting 2-3% of the general population. Resulting spine deformities include progressive coronal curvature, hypokyphosis, or frank lordosis in the thoracic spine and vertebral rotation in the axial plane with posterior elements turned into the curve concavity. The potential for curve progression is heightened during the adolescent growth spurt. Success of scoliosis deformity correction depends on solid bony fusion between adjacent vertebrae after the intervertebral discs have been surgically cleared and the disc spaces filled with graft material. Problems with bone graft harvest site morbidity as well as limited bone availability have led to the search for bone graft substitutes. Recently, a bioactive and resorbable scaffold fabricated from medical grade polycaprolactone (PCL) has been developed for bone regeneration at load bearing sites. Combined with recombinant human bone morphogenic protein–2 (rhBMP-2), this has been shown to be successful in acting as a bone graft substitute in acting as a bone graft substitute in a porcine lumbar interbody fusion model when compared to autologous bone graft. This in vivo sheep study intends to evaluate the suitability of a custom designed medical grade PCL scaffold in combination with rhBMP-2 as a bone graft substitute in the setting of mini–thoracotomy surgery as a platform for ongoing research to benefit patients with adolescent idiopathic scoliosis.

Establishment and characterisation of an open mini-thoracotomy surgical approach to an ovine thoracic spine fusion model

Background A large animal model is required for assessment of minimally invasive, tissue engineering based approaches to thoracic spine fusion, with relevance to deformity correction surgery for human adolescent idiopathic scoliosis. Here we develop a novel open mini–thoracotomy approach in an ovine model of thoracic interbody fusion which allows assessment of various fusion constructs, with a focus on novel, tissue engineering based interventions. Methods The open mini-thoracotomy surgical approach was developed through a series of mock surgeries, and then applied in a live sheep study. Customized scaffolds were manufactured to conform with intervertebral disc space clearances required of the study. Twelve male Merino sheep aged 4 to 6 years and weighing 35 – 45 kg underwent the abovementioned procedure and were divided into two groups of six sheep at survival timelines of 6 and 12 months. Each sheep underwent a 3-level discectomy (T6/7, T8/9 and T10/11) with randomly allocated implantation of a different graft substitute at each of the three levels; (i) polycaprolactone (PCL) based scaffold plus 0.54μg rhBMP-2, (ii) PCL-based scaffold alone or (iii) autograft. The sheep were closely monitored post- operatively for signs of pain (i.e. gait abnormalities/ teeth gnawing/ social isolation). Fusion assessments were conducted post-sacrifice using Computed Tomography and hard-tissue histology. All scientific work was undertaken in accordance with the study protocol has been approved by the Institute's committee on animal research. Results. All twelve sheep were successfully operated on and reached the allotted survival timelines, thereby demonstrating the feasibility of the surgical procedure and post-operative care. There were no significant complications and during the post-operative period the animals did not exhibit marked signs of distress according to the described assessment criteria. Computed Tomographic scanning demonstrated higher fusion grades in the rhBMP-2 plus PCL-based scaffold group in comparison to either PCL-based scaffold alone or autograft. These results were supported by histological evaluation of the respective groups. Conclusion. This novel open mini-thoracotomy surgical approach to the ovine thoracic spine represents a safe surgical method which can reproducibly form the platform for research into various spine tissue engineered constructs (TEC) and their fusion promoting properties.

The effect of testing protocol on immature bovine thoracic spine segment stiffness

Introduction. In vitro spine biomechanical testing has been central to many advances in understanding the physiology and pathology of the human spine. Owing to the difficulty in obtaining sufficient numbers of human samples to conduct these studies, animal spines have been accepted as a substitute model. However, it is difficult to compare results from different studies, as they use different preparation, testing and data collection methods. The aim of this study was to identify the effect of repeated cyclic loading on bovine spine segment stiffness. It also aimed to quantify the effect of multiple freeze-thaw sequences, as many tests would be difficult to complete in a single session [1-3]. Materials and Methods. Thoracic spines from 6-8 week old calves were used. Each spine was dissected and divided into motion segments including levels T4-T11 (n=28). These were divided into two equal groups. Each segment was potted in polymethylemethacrylate. An Instron Biaxial materials testing machine with a custom made jig was used for testing. The segments were tested in flexion/extension, lateral bending and axial rotation at 37 degrees C and 100% humidity, using moment control to a maximum plus/minus 1.75 Nm with a loading rate of 0.3 Nm per second. Group (A) were tested with continuous repeated cyclic loading for 500 cycles with data recorded at cycles 3, 5, 10, 25, 100, 200, 300, 400 and 500. Group (B) were tested with 10 load cycles after each of 5 freeze thaw sequences. Data was collected from the tenth load cycle after each sequence. Statistical analysis of the data was performed using paired samples t-tests, ANOVA and generalized estimating equations. Results. The data were confirmed as having a normal distribution. 1. There were significant reductions in mean stiffness in flexion/extension (-20%; P=0.001) and lateral bending (-17%; P=0.009) over the 500 load cycles. However, there was no statistically significant change in axial rotation (P=0.152) 2. There was no statistically significant difference between mean stiffness over the five freeze-thaw sequences in flexion/extension (p=0.879) and axial rotation (p=0.07). However, there was a significant reduction in stiffness in lateral bending (-26%; p=0.007) Conclusion. Biomechanical testing of immature bovine spine motion segments requires careful interpretation. The effect of the number of load cycles as well as the number of freeze-thaw cycles on the stiffness of the motion segments depends on the axis of main movement.

Segmental torso masses and coronal plane joint torques in the adolescent scoliotic spine

Introduction. Calculating segmental (vertebral level-by-level) torso masses in Adolescent Idiopathic Scoliosis (AIS) patients allows the gravitational loading on the scoliotic spine during relaxed standing to be determined. This study used CT scans of AIS patients to measure segmental torso masses and explores how joint moments in the coronal plane are affected by changes in the position of the intervertebral joint’s axis of rotation; particularly at the apex of a scoliotic major curve. Methods. Existing low dose CT data from the Paediatric Spine Research Group was used to calculate vertebral level-by-level torso masses and joint torques occurring in the spine for a group of 20 female AIS patients (mean age 15.0 ± 2.7 years, mean Cobb angle 53 ± 7.1°). Image processing software, ImageJ (v1.45 NIH USA) was used to threshold the T1 to L5 CT images and calculate the segmental torso volume and mass corresponding to each vertebral level. Body segment masses for the head, neck and arms were taken from published anthropometric data. Intervertebral (IV) joint torques at each vertebral level were found using principles of static equilibrium together with the segmental body mass data. Summing the torque contributions for each level above the required joint, allowed the cumulative joint torque at a particular level to be found. Since there is some uncertainty in the position of the coronal plane Instantaneous Axis of Rotation (IAR) for scoliosis patients, it was assumed the IAR was located in the centre of the IV disc. A sensitivity analysis was performed to see what effect the IAR had on the joint torques by moving it laterally 10mm in both directions. Results. The magnitude of the torso masses from T1-L5 increased inferiorly, with a 150% increase in mean segmental torso mass from 0.6kg at T1 to 1.5kg at L5. The magnitudes of the calculated coronal plane joint torques during relaxed standing were typically 5-7 Nm at the apex of the curve, with the highest apex joint torque of 7Nm being found in patient 13. Shifting the assumed IAR by 10mm towards the convexity of the spine, increased the joint torque at that level by a mean 9.0%, showing that calculated joint torques were moderately sensitive to the assumed IAR location. When the IAR midline position was moved 10mm away from the convexity of the spine, the joint torque reduced by a mean 8.9%. Conclusion. Coronal plane joint torques as high as 7Nm can occur during relaxed standing in scoliosis patients, which may help to explain the mechanics of AIS progression. This study provides new anthropometric reference data on vertebral level-by-level torso mass in AIS patients which will be useful for biomechanical models of scoliosis progression and treatment. However, the CT scans were performed in supine (no gravitational load on spine) and curve magnitudes are known to be smaller than those measured in standing.

Characterisation of Polycaprolatone-Based Scaffold Plus Recombinant Human Morphogenetic Protein - 2 (RHBMP-2) in an Ovine Thoracic Spine Model

This thesis represents a step forward in the development of a pre-clinical model investigating a suitable substitute for host bone for use in human spinal fusion. By way of an animal model, it examines the biological performance of a novel bone graft substitute comprised of a combination of a custom-designed biodegradable material and biologics.

Segmental torso masses and joint torques produced by gravity in the adolescent scoliotic spine

Introduction Calculating segmental torso masses in Adolescent Idiopathic Scoliosis (AIS) patients allows the gravitational loading on the scoliotic spine during relaxed standing to be estimated. Methods Low dose CT data was used to calculate vertebral level-by-level torso masses and spinal joint torques for 20 female AIS patients (mean age 15.0 ± 2.7 years, mean Cobb angle 53 ± 7.1°). ImageJ software (v1.45 NIH USA) was used to threshold the T1 to L5 CT images and calculate the segmental torso volume and mass for each vertebral level. Masses for the head, neck and arms were taken from published data.1 Intervertebral joint torques in the coronal and sagittal planes at each vertebral level were found from the position of the centroid of the segment masses relative to the joint centres (assumed to be at the centre of the intervertebral disc). The joint torque at each level was found by summing torque contributions for all segments above that joint. Results Segmental torso mass increased from 0.6kg at T1 to 1.5kg at L5. The coronal plane joint torques due to gravity were 5-7Nm at the apex of the curve; sagittal torques were 3-5.4Nm. Conclusion CT scans were in the supine position and curve magnitudes are known to be smaller than those in standing.2 Hence, this study has shown that gravity produces joint torques potentially of higher than 7Nm in the coronal plane and 5Nm in the sagittal plane during relaxed standing in scoliosis patients. The magnitude of these torques may help to explain the mechanics of AIS progression and the mechanics of bracing. This new data on torso segmental mass in AIS patients will assist biomechanical models of scoliosis.

Geometric sensitivity of patient-specific finite element models of the spine to variability in user-selected anatomical landmarks

Software to create individualised finite element (FE) models of the osseoligamentous spine using pre-operative computed tomography (CT) data-sets for spinal surgery patients has recently been developed. This study presents a geometric sensitivity analysis of this software to assess the effect of intra-observer variability in user-selected anatomical landmarks. User-selected landmarks on the osseous anatomy were defined from CT data-sets for three scoliosis patients and these landmarks were used to reconstruct patient-specific anatomy of the spine and ribcage using parametric descriptions. The intra-observer errors in landmark co-ordinates for these anatomical landmarks were calculated. FE models of the spine and ribcage were created using the reconstructed anatomy for each patient and these models were analysed for a loadcase simulating clinical flexibility assessment. The intra-observer error in the anatomical measurements was low in comparison to the initial dimensions, with the exception of the angular measurements for disc wedge and zygapophyseal joint (z-joint) orientation and disc height. This variability suggested that CT resolution may influence such angular measurements, particularly for small anatomical features, such as the z-joints, and may also affect disc height. The results of the FE analysis showed low variation in the model predictions for spinal curvature with the mean intra-observer variability substantially less than the accepted error in clinical measurement. These findings demonstrate that intra-observer variability in landmark point selection has minimal effect on the subsequent FE predictions for a clinical loadcase.

Segmental torso masses and joint torques produced by gravity in the adolescent scoliotic spine

Introduction Calculating segmental torso masses in Adolescent Idiopathic Scoliosis (AIS) patients allows the gravitational loading on the scoliotic spine during relaxed standing to be estimated. Methods Low dose CT data was used to calculate vertebral level-by-level torso masses and spinal joint torques for 20 female AIS patients (mean age 15.0 ± 2.7 years, mean Cobb angle 53 ± 7.1°). ImageJ software (v1.45 NIH USA) was used to threshold the T1 to L5 CT images and calculate the segmental torso volume and mass for each vertebral level. Masses for the head, neck and arms were taken from published data. Intervertebral joint torques in the coronal and sagittal planes at each vertebral level were found from the position of the centroid of the segment masses relative to the joint centres (assumed to be at the centre of the intervertebral disc. The joint torque at each level was found by summing torque contributions for all segments above that joint. Results Segmental torso mass increased from 0.6kg at T1 to 1.5kg at L5. The coronal plane joint torques due to gravity were 5-7Nm at the apex of the curve; sagittal torques were 3-5.4Nm. Conclusion CT scans were in the supine position and curve magnitudes are known to be smaller than those in standing. Hence, this study has shown that gravity produces joint torques potentially of higher than 7Nm in the coronal plane and 5Nm in the sagittal plane during relaxed standing in scoliosis patients. The magnitude of these torques may help to explain the mechanics of AIS progression and the mechanics of bracing. This new data on torso segmental mass in AIS patients will assist biomechanical models of scoliosis.

The stabilising role of the costovertebral joints and spinous processes on thoracic spine stability

Introduction The importance of in vitro biomechanical testing in today’s understanding of spinal pathology and treatment modalities cannot be stressed enough. Different studies have used differing levels of dissection of their spinal segments for their testing protocols[1, 2]. The aim of this study was to assess the impact of removing the costovertebral joints and partial resection of the spinous process sequentially, on the stiffness of the immature thoracic bovine spinal segment. Materials and Methods Thoracic spines from 6-8 week old calves were used. Each spine was dissected and divided into motion segments with 5cm of attached rib on each side and full spinous processes including levels T4-T11 (n=28). They were potted in polymethylemethacrylate. An Instron Biaxial materials testing machine with a custom made jig was used for testing. The segments were tested in flexion/extension, lateral bending and axial rotation at 37⁰C and 100% humidity, using moment control to a maximum 1.75 Nm with a loading rate of 0.3 Nm per second. They were first tested intact for ten load cycles with data collected from the tenth cycle. Progressive dissection was performed by removing first the attached ribs, followed by the spinous process at its base. Biomechanical testing was carried out after each level of dissection using the same protocol. Statistical analysis of the data was performed using repeated measures ANOVA. Results In combined flexion/extension there was a significant reduction in stiffness of 16% (p=0.002). This was mainly after resection of the ribs (14%, p=0.024) and mainly occurred in flexion where stiffness reduced by 22% (p=0.021). In extension, stiffness dropped by 13% (p=0.133). However there was no further significant change in stiffness on resection of the spinous process (<1%) (p=1.00). In lateral bending there was a significant decrease in stiffness of 13% (p<0.001). This comprised a drop of 11% on resection of the ribs (p=0.009) and a further 8% on resection of the spinous process (p=0.014). There was no difference between left and right bending. In axial rotation there was no significant change in stiffness after each stage of dissection (p=0.253). There was no difference between left and right rotation. Conclusion The costovertebral joints play a significant role in providing stability to the bovine thoracic spine in both flexion/extension and lateral bending, whereas the spinous processes play a minor role. Both elements have little effect on axial rotation stability.

The effect of intervertebral staple insertion on bovine spine segment stiffness

Introduction There is growing interest in the biomechanics of ‘fusionless’ implant constructs used for deformity correction in the thoracic spine. Intervertebral stapling is a leading method of fusionless corrective surgery. Although used for a number of years, there is limited evidence as to the effect these staples have on the stiffness of the functional spinal unit. Materials and Methods Thoracic spines from 6-8 week old calves were dissected and divided into motion segments including levels T4-T11 (n=14). Each segment was potted in polymethylemethacrylate. An Instron Biaxial materials testing machine with a custom made jig was used for testing. The segments were tested in flexion/extension, lateral bending and axial rotation at 37⁰C and 100% humidity, using moment control to a maximum 1.75 Nm with a loading rate of 0.3 Nm per second. This torque was found sufficient to achieve physiologically representative ranges of movement. The segments were initially tested uninstrumented with data collected from the tenth load cycle. Next a left anterolateral Shape Memory Alloy (SMA) staple was inserted (Medtronic Sofamor Danek, USA). Biomechanical testing was repeated as before with data collected from the tenth load cycle. Results In flexion/extension there was an insignificant drop in stiffness of 3% (p=0.478). In lateral bending there was a significant drop in stiffness of 21% (p<0.001). This was mainly in lateral bending away from the staple, where the stiffness reduced by 30% (p<0.001). This was in contrast to lateral bending towards the staple where it dropped by 12% which was still statistically significant (p=0.036). In axial rotation there was an overall near significant drop in stiffness of 11% (p=0.076). However, this was more towards the side of the staple measuring a decrease of 14% as opposed to 8% away from the staple. In both cases it was a statistically insignificant drop (p=0.134 and p=0.352 respectively). Conclusion Insertion of intervertebral SMA staples results in a significant reduction in motion segment stiffness in lateral bending especially in the direction away from the staple. The staple had less effect on axial rotation stiffness and minimal effect on flexion/extension stiffness.

Gravity-induced coronal plane joint moments in the adolescent scoliotic spine

INTRODUCTION Calculating segmental (vertebral level-by-level) torso masses in Adolescent Idiopathic Scoliosis (AIS) patients allows the gravitational loading on the scoliotic spine during relaxed standing to be estimated. METHODS Existing low dose CT scans were used to calculate vertebral level-by-level torso masses and joint moments occurring in the spine for a group of female AIS patients with right-sided thoracic curves. Image processing software, ImageJ (v1.45 NIH USA) was used to reconstruct the torso segments and subsequently measure the torso volume and mass corresponding to each vertebral level. Body segment masses for the head, neck and arms were taken from published anthropometric data. Intervertebral joint moments at each vertebral level were found by summing each of the torso segment masses above the required joint and multiplying it by the perpendicular distance to the centre of the disc. RESULTS AND DISCUSSION Twenty patients were included in this study with a mean age of 15.0±2.7 years and a mean Cobb angle 52±5.9°. The mean total trunk mass, as a percentage of total body mass, was 27.8 (SD 0.5) %. Mean segmental torso mass increased inferiorly from 0.6kg at T1 to 1.5kg at L5. The coronal plane joint moments during relaxed standing were typically 5-7Nm at the apex of the curve (Figure 1), with the highest apex joint of 7Nm. CT scans were performed in the supine position and curve magnitudes are known to be 7-10° smaller than those measured in standing [1]. Therefore joint moments produced by gravity will be greater than those calculated here. CONCLUSIONS Coronal plane joint moments as high as 7Nm can occur during relaxed standing in scoliosis patients, which may help to explain the mechanics of AIS progression. The body mass distributions calculated in this study can be used to estimate joint moments derived using other imaging modalities such as MRI and subsequently determine if a relationship exists between joint moments and progressive vertebral deformity.

Comparison of eight published static finite element models of the intact lumbar spine : predictive power of models improves when combined together

Finite element (FE) model studies have made important contributions to our understanding of functional biomechanics of the lumbar spine. However, if a model is used to answer clinical and biomechanical questions over a certain population, their inherently large inter-subject variability has to be considered. Current FE model studies, however, generally account only for a single distinct spinal geometry with one set of material properties. This raises questions concerning their predictive power, their range of results and on their agreement with in vitro and in vivo values. Eight well-established FE models of the lumbar spine (L1-5) of different research centres around the globe were subjected to pure and combined loading modes and compared to in vitro and in vivo measurements for intervertebral rotations, disc pressures and facet joint forces. Under pure moment loading, the predicted L1-5 rotations of almost all models fell within the reported in vitro ranges, and their median values differed on average by only 2° for flexion-extension, 1° for lateral bending and 5° for axial rotation. Predicted median facet joint forces and disc pressures were also in good agreement with published median in vitro values. However, the ranges of predictions were larger and exceeded those reported in vitro, especially for the facet joint forces. For all combined loading modes, except for flexion, predicted median segmental intervertebral rotations and disc pressures were in good agreement with measured in vivo values. In light of high inter-subject variability, the generalization of results of a single model to a population remains a concern. This study demonstrated that the pooled median of individual model results, similar to a probabilistic approach, can be used as an improved predictive tool in order to estimate the response of the lumbar spine.