An FE investigation simulating intra-operative corrective forces applied to correct scoliosis deformity

Background: Adolescent idiopathic scoliosis (AIS) is a deformity of the spine, which may 34 require surgical correction by attaching a rod to the patient’s spine using screws 35 implanted in the vertebral bodies. Surgeons achieve an intra-operative reduction in the 36 deformity by applying compressive forces across the intervertebral disc spaces while 37 they secure the rod to the vertebra. We were interested to understand how the 38 deformity correction is influenced by increasing magnitudes of surgical corrective forces 39 and what tissue level stresses are predicted at the vertebral endplates due to the 40 surgical correction. 41 Methods: Patient-specific finite element models of the osseoligamentous spine and 42 ribcage of eight AIS patients who underwent single rod anterior scoliosis surgery were 43 created using pre-operative computed tomography (CT) scans. The surgically altered 44 spine, including titanium rod and vertebral screws, was simulated. The models were 45 analysed using data for intra-operatively measured compressive forces – three load 46 profiles representing the mean and upper and lower standard deviation of this data 47 were analysed. Data for the clinically observed deformity correction (Cobb angle) were 48 compared with the model-predicted correction and the model results investigated to 49 better understand the influence of increased compressive forces on the biomechanics of 50 the instrumented joints. 51 Results: The predicted corrected Cobb angle for seven of the eight FE models were 52 within the 5° clinical Cobb measurement variability for at least one of the force profiles. 53 The largest portion of overall correction was predicted at or near the apical 54 intervertebral disc for all load profiles. Model predictions for four of the eight patients 55 showed endplate-to-endplate contact was occurring on adjacent endplates of one or 56 more intervertebral disc spaces in the instrumented curve following the surgical loading 57 steps. 58 Conclusion: This study demonstrated there is a direct relationship between intra-59 operative joint compressive forces and the degree of deformity correction achieved. The 60 majority of the deformity correction will occur at or in adjacent spinal levels to the apex 61 of the deformity. This study highlighted the importance of the intervertebral disc space 62 anatomy in governing the coronal plane deformity correction and the limit of this 63 correction will be when bone-to-bone contact of the opposing vertebral endplates 64 occurs.

Behaviour and design of crest-fixed profiled steel roof claddings under wind uplift

Profiled steel roof claddings in Australia are commonly made of very thin high tensile steel and are crest-fixed with screw fasteners. At present the design of these claddings is entirely based on testing. In order to improve the understanding of the behaviour of these claddings under wind uplift, and thus the design methods, a detailed investigation consisting of a finite element analysis and laboratory experiments was carried out on two-span roofing assemblies of three common roofing profiles. It was found that the failure of the roof cladding system was due to a local failure (dimpling of crests/pull-through) at the fasteners. This paper presents the details of the investigation, the results and then proposes a design method based on the strength of the screwed connections, for which testing of small-scale roofing models and/or using a simple design formula is recommended.

Cyclic pull-out strength of steel roof and wall cladding systems

When crest-fixed thin steel roof cladding systems are subjected to wind uplift, local pull-through or pull-out failures occur prematurely at their screwed connections. During high wind events such as storms and cyclones these localised failures then lead to severe damage to buildings and their contents. In recent times, the use of thin steel battens/purlins has increased considerably. This has made the pull-out failures more critical in the design of steel cladding systems. Recent research has developed a design formula for the static pull-out strength of steel cladding systems. However, the effects of fluctuating wind uplift loading that occurs during high wind events are not known. Therefore a series of constant amplitude cyclic tests has been undertaken on connections between steel battens made of different thicknesses and steel grades, and screw fasteners with varying diameter and pitch. This paper presents the details of these cyclic tests and the results.

Predicting the fatigue life of internal fracture fixation plates

Failures of fracture fixation plates, often related to fatigue fractures of the implants, have been reported (Banovetz et al, 1996). While metallurgical defects can usually be excluded, many of these fractures can be explained with the biomechanical situation. This study investigated the biomechanics of two clinical cases, both of which used a 14-hole locking compression plate. In the first case, a titanium plate was used in a rigid configuration with 12 screws resulting in plate breakage after 7 weeks (Sommer et al, 2003). In the second case, a stainless steel plate, which endured the entire healing process, was used in a flexible application with only 6 screws.

A biomechanical analysis of growing rods used in the management of early onset scoliosis

INTRODUCTION Managing spinal deformities in young children is challenging, particularly early onset scoliosis (EOS). Surgical intervention is often required if EOS has been unresponsive to conservative treatment particularly with rapidly progressive curves. An emerging treatment option for EOS is fusionless scoliosis surgery. Similar to bracing, this surgical option potentially harnesses growth, motion and function of the spine along with correcting spinal deformity. Dual growing rods are one such fusionless treatment, which aims to modulate growth of the vertebrae. The aim of this study was to ascertain the extent to which semiconstrained growing rods (Medtronic, Sofamor, Danek, Memphis, TN) with a telescopic sleeve component, reduce rotational constraint on the spine compared with standard "constrained / rigid" rods and hence potentially provide a more physiological mechanical environment for the growing spine. METHODS Six 40-60kg English Large White porcine spines served as a model for the paediatric human spine. Each spine was dissected into a 7 level thoracolumbar multi-segment unit (MSU), removing all non-ligamentous soft tissues and leaving 3cm of ribs either side. Pure nondestructive axial rotation moments of ±4Nm at a constant rotation rate of 8deg.s-1 were applied to the mounted MSU spines using a biaxial Instron testing machine. Displacement of each vertebral level was captured using a 3D motion tracking system (Optotrak 3020, Northern Digital Inc, Waterloo, ON). Each spine was tested in an un-instrumented state first and then with appropriately sized semi-constrained growing rods and rigid rods in alternating sequence. The rods were secured by multi-axial pedicle screws (Medtronic CD Horizon) at levels 2 and 6 of the construct. The range of motion (ROM), neutral zone (NZ) size and stiffness (Nm.deg-1) were calculated from the Instron load-displacement data and intervertebral ROM was calculated through a MATLAB algorithm from Optotrak data. RESULTS Irrespective of the order of testing, rigid rods significantly reduced the total ROM compared with semi-constrained rods (p<0.05) with in a significantly stiffer spine for both left and right axial rotation (p<0.05). Analysing the intervertebral motion within the instrumented levels 2-6, rigid rods showed reduced ROM compared with semi-constrained growing rods and compared with un-instrumented motion segments. CONCLUSION Semi-constrained growing rods maintain similar stiffness in axial rotation to un-instrumented spines, while dual rigid rods significantly reduce axial rotation. Clinically the effect of semi-constrained growing rods as observed in this study is that they would be expected to allow growth via the telescopic rod components while maintaining the axial flexibility of the spine, which may reduce occurrence of the crankshaft phenomenon.

Thoracoscopic scoliosis surgery – a cheaper option? A cost analysis of 189 consecutive cases

INTRODUCTION: Increasing health care costs, limited resources and increased demand makes cost effective and cost-efficient delivery of Adolescent Idiopathic Scoliosis (AIS) management paramount. Rising implant costs in deformity correction surgery have prompted analysis of whether high implant densities are justified. The objective of this study was to analyse the costs of thoracoscopic scoliosis surgery, comparing initial learning curve costs with those of the established technique and to the costs involved in posterior instrumented fusion from the literature. METHODS: 189 consecutive cases from April 2000 to July 2011 were assessed with a minimum of 2 years follow-up. Information was gathered from a prospective database covering perioperative factors, clinical and radiological outcomes, complications and patient reported outcomes. The patients were divided into three groups to allow comparison; 1. A learning curve cohort, 2. An intermediate cohort and 3. A third cohort of patients, using our established technique. Hospital finance records and implant manufacturer figures were corrected to 2013 costs. A literature review of AIS management costs and implant density in similar curve types was performed. RESULTS: The mean pre-op Cobb angle was 53°(95%CI 0.4) and was corrected postop to mean 22.9°(CI 0.4). The overall complication rate was 20.6%, primarily in the first cohort, with a rate of 5.6% in the third cohort. The average total costs were $46,732, operating room costs of $10,301 (22.0%) and ICU costs of $4620 (9.8%). The mean number of screws placed was 7.1 (CI 0.04) with a single rod used for each case giving average implant costs of $14,004 (29.9%). Comparison of the three groups revealed higher implant costs as the technique evolved to that in use today, from $13,049 in Group 1 to $14577 in Group 3 (P<0.001). Conversely operating room costs reduced from $10,621 in Group 1 to $7573 (P<0.001) in Group 3. ICU stay was reduced from an average of 1.2 to 0 days. In-patient stay was significantly (P=0.006) lower in Groups 2 and 3 (5.4 days) than Group 1 (5.9 days) (i.e. a reduction in cost of approximately $6,140). CONCLUSIONS: The evolution of our thoracoscopic anterior scoliosis correction has resulted in an increase in the number of levels fused and reduction in complication rate. Implant costs have risen as a result, however, there has been a concurrent decrease in those costs generated by operating room use, ICU and in-patient stay with increasing experience. Literature review of equivalent curve types treated posteriorly shows similar perioperative factors but higher implant density, 69-83% compared to the 50% in this study. Thoracoscopic Scoliosis surgery presents a low density, reliable, efficient and effective option for selected curves. A cost analysis of Thoracoscopic Scoliosis Surgery using financial records and a prospectively collected database of all patients since 2000, demonstrating a clear cost advantage compared to equivalent posterior instrumentation and fusion.

A biomechanical analysis of growing rods used in the management of early onset scoliosis

INTRODUCTION Managing spinal deformities in young children is challenging, particularly early-onset scoliosis (EOS). Any progressive spinal deformity particularly in early life presents significant health risks for the child and a challenge for the treating surgeon. Surgical intervention is often required if EOS has been unresponsive to conservative treatment particularly with rapidly progressive curves. An emerging treatment option particularly for EOS is fusionless scoliosis surgery. Similar to bracing this surgical option potentially harnesses growth, motion and function of the spine along with correcting spinal deformity. Dual growing rods is one such fusionless treatment, which aims to modulate growth of the vertebrae. The aim of this study was to ascertain the extent to which semi-constrained growing rods (Medtronic, Memphis, TN) with a telescopic sleeve component, reduce rotational constraint on the spine compared with standard rigid rods and hence potentially provide a more physiological mechanical environment for the growing spine. METHODS Six 40-60kg English Large White porcine spines served as a model for the paediatric human spine. Each spine was dissected into 7 level thoracolumbar multi-segment unit (MSU) spines, removing all non-ligamentous soft tissues. Appropriately sized semi-constrained growing rods and rigid rods were secured by multi-axial screws (Medtronic) prior to testing in alternating sequences for each spine. Pure nondestructive moments of +/4Nm at a constant rotation rate of 8deg/s was applied to the mounted MSU spines. Displacement of each level was captured using an Optotrak (Northern Digital Inc, Waterloo, ON). The range of motion (ROM), neutral zone (NZ) size and stiffness (Nm/deg) were calculated from the Instron load-displacement data and intervertebral ROM was calculated through a MATLAB algorithm from Optotrak data. RESULTS Irrespective of sequence order rigid rods significantly reduced the total ROM (deg) than compared to semi-constrained rods (p<0.05) and resulted in a significantly stiffer (Nm/deg) spine for both left and right axial rotation testing (p<0.05). Analysing the intervertebral motion within the instrumented levels, rigid rods showed reduced ROM (Deg) than compared to semi-constrained growing rods and the un-instrumented (UN-IN) test sequences. CONCLUSION The semi-constrained growing rods maintained rotation similar to UN-IN spines while the rigid rods showed significantly reduced axial rotation across all instrumented levels. Clinically the effect of semi-constrained growing rods evaluated in this study is that they will allow growth via the telescopic rod components while maintaining the axial rotation ability of the spine, which may also reduce the occurrence of the crankshaft phenomenon.

Using patient specific finite element models to understand the biomechanics of paediatric spinal deformity surgery

Adolescent idiopathic scoliosis (AIS) is a spinal deformity, which may require surgical correction by attaching rods to the patient’s spine using screws inserted into the vertebrae. Complication rates for deformity correction surgery are unacceptably high. Determining an achievable correction without overloading the adjacent spinal tissues or implants requires an understanding of the mechanical interaction between these components. We have developed novel patient specific modelling software to create individualized finite element models (FEM) representing the thoracolumbar spine and ribcage of scoliosis patients. We are using these models to better understand the biomechanics of spinal deformity correction.

Morphometric analysis of the thoracic intervertebral foramen osseous anatomy in adolescent idiopathic scoliosis using low dose computerized tomography

Introduction. The dimensions of the thoracic intervertebral foramen in adolescent idiopathic scoliosis (AIS) have not previously been quantified. During posterior approach scoliosis correction surgery pedicle screws may occasionally breach into the foramen. Better understanding of the dimensions of the foramen may be useful in surgical planning. This study describes a reproducible method for measurement of the thoracic foramen in AIS using computerized tomography (CT). Methods. In 23 pre-operative female patients with Lenke 1 type AIS with right side convexity major curves confined to the thoracic spine the foraminal height (FH), foraminal width (FW), pedicle to superior articular process distance (P-SAP) and cross sectional foraminal area (FA) were measured using multiplanar reconstructed CT. Measurements were made at entrance, midpoint and exit of the thoracic foramina from T1/T2 to T11/T12. Results were correlated with potential dependent variables of major curve Cobb Angle measured on X-ray and CT, Age, Weight, Lenke classification subtype, Risser Grade and number of spinal levels in the major curve. Results. The FH, FW, P-SAP and FA dimensions and ratios are all significantly larger on the convexity of the major curve and maximal at or close to the apex. Mean thoracic foraminal dimensions change in a predictable manner relative to position on the major thoracic curve. There was no significant correlation with the measured foraminal dimensions or ratios and the potential dependent variables. The average ratio of convexity to concavity dimensions at the apex foramina for entrance, midpoint and exit respectively are FH (1.50, 1.38, 1.25), FW (1.28, 1.30, 0.98), FA (2.06, 1.84, 1.32), P-SAP (1.61, 1.47, 1.30). Conclusion. Foraminal dimensions of the thoracic spine are significantly affected by AIS. Foraminal dimensions have a predictable convexity to concavity ratio relative to the proximity to the major curve apex. Surgeons should be aware of these anatomical differences during scoliosis correction surgery.

Using low dose computerized tomography to morphometrically analyse the thoracic intervertebral foramen osseous anatomy in adolescent idiopathic scoliosis

INTRODUCTION The dimensions of the thoracic intervertebral foramen in adolescent idiopathic scoliosis (AIS) have not previously been quantified. During posterior approach scoliosis correction surgery pedicle screws may occasionally breach into the foramen. Better understanding of the dimensions of the foramen may be useful in surgical planning. This study describes a reproducible method for measurement of the thoracic foramen in AIS using computerized tomography (CT). METHODS In 23 pre-operative female patients with Lenke 1 type AIS with right side convexity major curves confined to the thoracic spine the foraminal height (FH), foraminal width (FW), pedicle to superior articular process distance (P-SAP) and cross sectional foraminal area (FA) were measured using multiplanar reconstructed CT. Measurements were made at entrance, midpoint and exit of the thoracic foramina from T1/T2 to T11/T12. Results were correlated with potential dependent variables of major curve Cobb Angle measured on X-ray and CT, Age, Weight, Lenke classification subtype, Risser Grade and number of spinal levels in the major curve. RESULTS The FH, FW, P-SAP and FA dimensions and ratios are all significantly larger on the convexity of the major curve and maximal at or close to the apex. Mean thoracic foraminal dimensions change in a predictable manner relative to position on the major thoracic curve. There was no significant correlation with the measured foraminal dimensions or ratios and the potential dependent variables. The average ratio of convexity to concavity dimensions at the apex foramina for entrance, midpoint and exit respectively are FH (1.50, 1.38, 1.25), FW (1.28, 1.30, 0.98), FA (2.06, 1.84, 1.32), P-SAP (1.61, 1.47, 1.30). CONCLUSION Foraminal dimensions of the thoracic spine are significantly affected by AIS. Foraminal dimensions have a predictable convexity to concavity ratio relative to the proximity to the major curve apex. Surgeons should be aware of these anatomical differences during scoliosis correction surgery.

Predicting surgical outcomes for paediatric spinal deformity patients using subject specific finite element models

INTRODUCTION Adolescent idiopathic scoliosis (AIS) is a spinal deformity, which may require surgical correction by attaching rods to the patient’s spine using screws inserted into the vertebrae. Complication rates for deformity correction surgery are unacceptably high. Determining an achievable correction without overloading the adjacent spinal tissues or implants requires an understanding of the mechanical interaction between these components. Our novel patient specific modelling software creates individualized finite element models (FEM) representing the thoracolumbar spine and ribcage of scoliosis patients. We have recently applied the model to investigate the influence of increasing magnitudes of surgically applied corrective force on predicted deformity correction...

An eigenproblem approach to classical screw theory

This paper presents a novel algebraic formulation of the central problem of screw theory, namely the determination of the principal screws of a given system. Using the algebra of dual numbers, it shows that the principal screws can be determined via the solution of a generalised eigenproblem of two real, symmetric matrices. This approach allows the study of the principal screws of the general two-, three-systems associated with a manipulator of arbitrary geometry in terms of closed-form expressions of its architecture and configuration parameters. We also present novel methods for the determination of the principal screws for four-, five-systems which do not require the explicit computation of the reciprocal systems. Principal screws of the systems of different orders are identified from one uniform criterion, namely that the pitches of the principal screws are the extreme values of the pitch.The classical results of screw theory, namely the equations for the cylindroid and the pitch-hyperboloid associated with the two-and three-systems, respectively have been derived within the proposed framework. Algebraic conditions have been derived for some of the special screw systems. The formulation is also illustrated with several examples including two spatial manipulators of serial and parallel architecture, respectively.

The development of a component to improve the loading safety of bone-anchored prostheses

Use of socket prostheses Currently, for individuals with limb loss, the conventional method of attaching a prosthetic limb relies on a socket that fits over the residual limb. However, there are a number of issues concerning the use of a socket (e.g., blisters, irritation, and discomfort) that result in dissatisfaction with socket prostheses, and these lead ultimately a significant decrease in quality of life. Bone-anchored prosthesis Alternatively, the concept of attaching artificial limbs directly to the skeletal system has been developed (bone anchored prostheses), as it alleviates many of the issues surrounding the conventional socket interface.Bone anchored prostheses rely on two critical components: the implant, and the percutaneous abutment or adapter, which forms the connection for the external prosthetic system (Figure 1). To date, an implant that screws into the long bone of the residual limb has been the most common intervention. However, more recently, press-fit implants have been introduced and their use is increasing. Several other devices are currently at various stages of development, particularly in Europe and the United States. Benefits of bone-anchored prostheses Several key studies have demonstrated that bone-anchored prostheses have major clinical benefits when compared to socket prostheses (e.g., quality of life, prosthetic use, body image, hip range of motion, sitting comfort, ease of donning and doffing, osseoperception (proprioception), walking ability) and acceptable safety, in terms of implant stability and infection. Additionally, this method of attachment allows amputees to participate in a wide range of daily activities for a substantially longer duration. Overall, the system has demonstrated a significant enhancement to quality of life. Challenges of direct skeletal attachment However, due to the direct skeletal attachment, serious injury and damage can occur through excessive loading events such as during a fall (e.g., component damage, peri-prosthetic fracture, hip dislocation, and femoral head fracture). These incidents are costly (e.g., replacement of components) and could require further surgical interventions. Currently, these risks are limiting the acceptance of bone-anchored technology and the substantial improvement to quality of life that this treatment offers. An in-depth investigation into these risks highlighted a clear need to re-design and improve the componentry in the system (Figure 2), to improve the overall safety during excessive loading events. Aim and purposes The ultimate aim of this doctoral research is to improve the loading safety of bone-anchored prostheses, to reduce the incidence of injury and damage through the design of load restricting components, enabling individuals fitted with the system to partake in everyday activities, with increased security and self-assurance. The safety component will be designed to release or ‘fail’ external to the limb, in a way that protects the internal bone-implant interface, thus removing the need for restorative surgery and potential damage to the bone. This requires detailed knowledge of the loads typically experienced by the limb and an understanding of potential overload situations that might occur. Hence, a comprehensive review of the loading literature surrounding bone anchored prostheses will be conducted as part of this project, with the potential for additional experimental studies of the loads during normal activities to fill in gaps in the literature. This information will be pivotal in determining the specifications for the properties of the safety component, and the bone-implant system. The project will follow the Stanford Biodesign process for the development of the safety component.

The effects of low-intensity ultrasound in bioabsorbable self-reinforced poly-L-lactide -fixed cancellous bone fracture

The purpose of the present study was to investigate the effects of low-intensity ultrasound on bioabsorbable self-reinforced poly-L-lactide (SR-PLLA) screws and on fracture healing after SR-PLLA device fixation in experimental and clinical cancellous bone fracture. In the first experimental study, the assessment of the mechanical strengths of the SR-PLLA screws was performed after 12 weeks of daily 20-minute ultrasound exposure in vitro. In the second experimental study, 32 male Wistar rats with an experimental distal femur osteotomy fixed with an SR-PLLA rod were exposed for daily low-intensity ultrasound treatment for 21 days. The effects on the healing bone were assessed. The clinical studies consist of three prospective, randomized, and placebo-controlled series of dislocated lateral malleolar fractures fixed with one SR-PLLA screw. The total number of the patients in these series was 52. Half of the patients were provided randomly with a sham ultrasound device. The patients underwent ultrasound therapy 20 minutes daily for six weeks. Radiological bone healing was assessed both by radiographs at two, six, nine, and 12 weeks and by multidetector computed tomography (MDCT) scans at two weeks, nine weeks, and 18 months. Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA). The clinical outcome was assessed by both Olerud-Molander scoring and clinical examination of the ankle. Low-intensity ultrasound had no effects on the mechanical properties and degradation behaviour of the SR-PLLA screws in vitro. There were no obvious signs of low-intensity ultrasound-induced enhancement in the bone healing in SR-PLLA-rod-fixed metaphyseal distal femur osteotomy in rats. The biocompatibility of low-intensity ultrasound treatment and SR-PLLA was found to be good. In the clinical series low-intensity ultrasound was observed to have no obvious effects on the bone mineral density of the fractured lateral malleolus. There were no obvious differences in the radiological bone healing times of the SR-PLLA-screw-fixed lateral malleolar fractures after low-intensity ultrasound treatment. Low-intensity ultrasound did not have any effects on radiological bone morphology, bone mineral density or clinical outcome 18 months after the injury. There were no obvious findings in the present study to support the hypothesis that low-intensity pulsed ultrasound enhances bone healing in SR-PLLA-rod-fixed experimental metaphyseal distal femur osteotomy in rats or in clinical SR-PLLA-screw-fixed lateral malleolar fractures. It is important to limit the conclusions of the present set of studies only to lateral malleolar fractures fixed with an SR-PLLA screw.

Classical screw theory: A fresh look using dual eigenvalue approach

This paper presents a novel algebraic formulation of the central problem of screw theory, namely the determination of the principal screws of a given system. Using the algebra of dual numbers, it shows that the principal screws can be determined via the solution of a generalised eigenproblem of two real, symmetric matrices. This approach allows the study of the principal screws of the general screw systems associated with a manipulator of arbitrary geometry in terms of closed-form expressions of its architecture and configuration parameters. The formulation is illustrated with examples of practical manipulators.