Biomechanical modeling and assessment of lumbar vertebral body tethering configurations.

PURPOSE: Vertebral body tethering (VBT) is a fusionless spinal growth modulation technique, which shows promise for pediatric idiopathic scoliosis (IS) curve correction. This technique, mainly used for thoracic curves, is increasingly being used to treat lumbar curves in order to preserve spine flexibility. It remains necessary to adequately define the cord tension to be applied during the operation and the instrumented levels to biomechanically predict correction over time for the lumbar spine. METHODS: Twelve pediatric patients with lumbar IS, treated with lumbar-only or lumbar and thoracic VBT, were selected for this study. Three independent variables were tested alternately using a patient-specific finite element model (FEM), which includes an algorithm modeling vertebra growth and spine curve changes due to growth modulation for 24 months post-operatively according to the Hueter-Volkmann principle. Parameters included cable tensioning (150N/250N), upper instrumented level (actual UIV, UIV-1) and lower instrumented level (actual LIV, LIV + 1). Each FEM was personalized using 3D radiographic reconstruction and flexibility supine radiographs. RESULT: An increase in cord tension (from 150 to 250N) had significant effects on main thoracic and thoraco-lumbar/lumbar Cobb angles, as well as on lumbar lordosis, after surgery (supplementary average correction of 3° and 8°, and increase of 1.4°, respectively) and after 24 months (4°, 10° and 1.1°) (p < 0.05). Adding a level to the actual UIV or LIV did not improve correction. CONCLUSION: This parametric study showed that cord tension is the most important biomechanical parameter on the simulated immediate and 2-year increase in lumbar curve correction. Our preliminary model suggests that it is not advantageous to add additional instrumented levels. LEVEL OF EVIDENCE: This computational study uses a retrospective validation cohort (level of evidence 3).

Prediction of post-operative adding-on or compensatory lumbar curve correction after anterior vertebral body tethering.

PURPOSE: Anterior Vertebral Body Tethering (AVBT), a fusionless surgical technique based on growth modulation, aims to correct pediatric scoliosis over time. However, medium-term curvature changes of the non-instrumented distal lumbar curve remains difficult to predict. The objective was to biomechanically analyze the level below the LIV to evaluate whether adding-on or compensatory lumbar curve after AVBT can be predicted by intervertebral disc (ID) wedging and force asymmetry. METHODS: 33 retrospective scoliotic cases instrumented with AVBT were used to computationally simulate their surgery and 2-year post-operative growth modulation using a finite element model. The cohort was divided into two subgroups according to the lumbar curvature evolution over 2 years: (1) correction > 10° (C); (2) maintaining ± 10° (M). The lumbar Cobb angle and residual ID wedging angle under LIV were measured. Simulated pressures and moments at the superior endplate of LIV + 1 were post-processed. These parameters were correlated at 2 years postoperatively. FINDINGS: On average, the LIV + 1 simulated moment was 538 Nmm for subgroup C, 155 Nmm for subgroup M with lumbar Cobb angle > 20° and 34 Nmm for angle < 20° whereas the ID angle was 1° for C and 0° for M. INTERPRETATION: On average, a positive moment on the LIV + 1 superior growth plate led to correction of the lumbar curvature, whereas a null moment kept it stable, and a parallel immediate postoperative ID under LIV contributed to its correction or preservation. Nevertheless, the significant interindividual variability suggested that other parameters are involved in the distal non-instrumented curvature evolution. LEVEL OF EVIDENCE: IV.

3D Radiological Outcomes and Quality of Life of Patients With Moderate Idiopathic Scoliosis Treated With Anterior Vertebral Growth Modulation Versus Bracing: Two-Year Follow-up.

STUDY DESIGN: Observational cohort study. OBJECTIVE: To test the hypothesis that anterior vertebral body growth modulation (AVBGM) achieves 3D deformity correction after 2-year follow-up while brace treatment limits curve progression for moderate idiopathic scoliosis (30-50°). SUMMARY OF BACKGROUND DATA: For idiopathic scoliosis, bracing and AVBGM have overlapping indications in skeletally immature patients with moderate scoliosis curve angles, creating a grey zone in clinical practice between them. The relative 3D deformity control performance over a 2-year period between these fusionless treatments is still uncertain. METHODS: A retrospective review of a prospective idiopathic scoliosis patients database, recruited between 2013 and 2018 was performed. Inclusion criteria were skeletally immature patients (Risser 0-2), with Cobb angles between 30° and 50° and a 2-year follow-up after bracing or AVBGM. 3D radiological parameters and health related quality of life (HRQoL) scores were evaluated. Unpaired t test was used. RESULTS: Thirty nine patients (12.7 ± 1.3 y.o.) with Cobb angles more than or equal to 30° treated with brace and 41 patients (11.8 ± 1.2 y.o.) with presenting Cobb angles less than or equal to 50° who received AVBGM were reviewed. The statistical analysis of 3D deformity measurements showed that at 2-year follow-up, only the 3D spine length and both sides apical vertebral heights changed significantly with brace treatment. While AVBGM treatment achieved statistically significant correction differences in thoracic and lumbar Cobb angles, TrueKyphosis, 3D spine length, and selective left apical vertebral height ( P < 0.05). 35% of brace patients had a curve progression of more than 5° at final follow-up while it was 0% for AVBGM. HRQoL assessment showed no statistically significant differences between pre and post SRS-22 total scores for each group ( P > 0.05). CONCLUSION: Even though these two cohorts are not fully comparable, bracing seems to control progression for a significant portion of patients with moderate scoliosis curves, while AVBGM significantly corrected and maintained 3D deformity parameters at 2-year follow-up.

Braces Designed Using CAD/CAM Combined or Not With Finite Element Modeling Lead to Effective Treatment and Quality of Life After 2 Years: A Randomized Controlled Trial.

STUDY DESIGN: Single-center prospective randomized controlled trial. OBJECTIVE: The aim of this study was to assess the computer-aided design/manufacturing (CAD/CAM) brace design approach, with and without added finite element modeling (FEM) simulations, after 2 years in terms of clinical outcomes, 3D correction, compliance, and quality of life (QoL). SUMMARY OF BACKGROUND DATA: .: Previous studies demonstrated that braces designed using a combination of CAD/CAM and FEM induced promising in-brace corrections, were lighter, thinner, and covered less trunk surface. Yet, their long-term impact on treatment quality has not been evaluated. METHODS: One-hundred twenty adolescent idiopathic scoliosis patients were recruited following Scoliosis Research Society standardized criteria for brace treatment; 61 patients in the first subgroup (CAD) were given braces designed using CAD/CAM; 59 in the second subgroup (CAD-FEM) received braces additionally simulated and refined using a patient-specific FEM built from 3D reconstructions of the spine, rib cage and pelvis. Main thoracic (MT) and thoraco-lumbar/lumbar (TL/L) Cobb angles, sagittal curves, and apical rotations were compared at the initial visit and after 2 years. Patient compliance and QoL were tracked respectively by using embedded temperature sensors and SRS-22r questionnaires. RESULTS: Forty-four patients with CAD-FEM braces and 50 with CAD braces completed the study. Average in-brace correction was 9° MT (8° CAD-FEM, 10° CAD, P = 0.054) and 12° TL/L (same for both subgroups, P = 0.91). Out-of-brace 2-year progression from initial deformity was <4° for all 3D measurements. Sixty-six percent of all cases (30 CAD-FEM, 35 CAD) met the ≤5° curve progression criterion, 83% (38 CAD-FEM, 43 CAD) stayed <45°, and 6% (5 CAD-FEM, 1 CAD) underwent fusion surgery. 3D correction, compliance, and QoL were not significantly different between both subgroups (P > 0.05). CONCLUSION: After 2 years, patients with braces designed using CAD/CAM with/without FEM had satisfying clinical outcomes (compared to the BrAIST study), 3D corrections, compliance and QoL. A more comprehensive optimization of brace treatment remains to be accomplished. LEVEL OF EVIDENCE: 2.

Anterior Vertebral Body Growth Modulation: Assessment of the 2-year Predictive Capability of a Patient-specific Finite-element Planning Tool and of the Growth Modulation Biomechanics.

STUDY DESIGN: Numerical planning and simulation of immediate and after 2 years growth modulation effects of anterior vertebral body growth modulation (AVBGM). OBJECTIVE: The objective was to evaluate the planning tool predictive capability for immediate, 1-year, and 2-year postoperative correction and biomechanical effect on growth modulation over time. SUMMARY OF BACKGROUND DATA: AVBGM is used to treat pediatric scoliotic patients with remaining growth potential. A planning tool based on a finite element model (FEM) of pediatric scoliosis integrating growth was previously developed to simulate AVBGM installation and growth modulation effect. METHODS: Forty-five patients to be instrumented with AVBGM were recruited. A patient-specific FEM was preoperatively generated using a 3D reconstruction obtained from biplanar radiographs. The FEM was used to assess different instrumentation configurations. The strategy offering the optimal 2-year postoperative correction was selected for surgery. Simulated 3D correction indices, as well as stresses applied on vertebral epiphyseal growth plates, intervertebral discs, and instrumentation, were computed. RESULTS: On average, six configurations per case were tested. Immediate, 1-year, and 2-year postoperative 3D correction indices were predicted within 4° of that of actual results in coronal plane, whereas it was <0.8 cm (±2%) for spinal height. Immediate postoperative correction was of 40%, whereas an additional correction of respectively 13% and 3% occurred at 1- and 2 year postoperative. The convex/concave side computed forces difference at the apical level following AVBGM installation was decreased by 39% on growth plates and 46% on intervertebral discs. CONCLUSION: This study demonstrates the FEM clinical usefulness to rationalize surgical planning by providing clinically relevant correction predictions. The AVBGM biomechanical effect on growth modulation over time seemed to be maximized during the first year following the installation. LEVEL OF EVIDENCE: 3.

Contribution of Lateral Decubitus Positioning and Cable Tensioning on Immediate Correction in Anterior Vertebral Body Growth Modulation.

STUDY DESIGN: Computational simulation of lateral decubitus and anterior vertebral body growth modulation (AVBGM). OBJECTIVES: To biomechanically evaluate lateral decubitus and cable tensioning contributions on intra- and postoperative correction. SUMMARY OF BACKGROUND DATA: AVBGM is a compression-based fusionless procedure to treat progressive pediatric scoliosis. During surgery, the patient is positioned in lateral decubitus, which reduces spinal curves. The deformity is further corrected with the application of compression by cable tensioning. Predicting postoperative correction following AVBGM installation remains difficult. METHODS: Twenty pediatric scoliotic patients instrumented with AVBGM were recruited. Three-dimensional (3D) reconstructions obtained from calibrated biplanar radiographs were used to generate a personalized finite element model. Intraoperative lateral decubitus position and installation of AVBGM were simulated to evaluate the intraoperative positioning and cable tensioning (100 / 150 / 200 N) relative contribution on intra- and postoperative correction. RESULTS: Average Cobb angles prior to surgery were 56° ± 10° (thoracic) and 38° ± 8° (lumbar). Simulated presenting growth plate's stresses were of 0.86 MPa (concave side) and 0.02 MPa (convex side). The simulated lateral decubitus reduced Cobb angles on average by 30% (thoracic) and 18% (lumbar). Cable tensioning supplementary contribution on intraoperative spinal correction was of 15%, 18%, and 24% (thoracic) for 100, 150, and 200 N, respectively. Simulated Cobb angles for the postoperative standing position were 39°, 37°, and 33° (thoracic) and 30°, 29°, and 28° (lumbar), respectively, whereas growth plate's stresses were of 0.54, 0.53, and 0.51 MPa (concave side) and 0.36, 0.53, and 0.68 MPa (convex side) for the three tensions. CONCLUSION: The majority of curve correction was achieved by lateral decubitus positioning. The main role of the cable was to apply supplemental periapical correction and secure the intraoperative positioning correction. Increases in cable tensioning furthermore rebalanced initially asymmetric compressive stresses. This study could help improve the design of AVBGM by understanding the contributions of the surgical procedure components to the overall correction achieved. LEVEL OF EVIDENCE: Level III.

Surgical Planning and Follow-up of Anterior Vertebral Body Growth Modulation in Pediatric Idiopathic Scoliosis Using a Patient-Specific Finite Element Model Integrating Growth Modulation.

STUDY DESIGN: Numerical planning and simulation of immediate and post-two-year growth modulation effects of Anterior Vertebral Body Growth Modulation (AVBGM). OBJECTIVES: To develop a planning tool based on a patient-specific finite element model (FEM) of pediatric scoliosis integrating growth to computationally assess the 3D biomechanical effects of AVBGM. SUMMARY OF BACKGROUND DATA: AVBGM is a recently introduced fusionless compression-based approach for pediatric scoliotic patients presenting progressive curves. Surgical planning is mostly empirical, with reported issues including overcorrection (inversion of the side) of the curve and a lack of control on 3D correction. METHODS: Twenty pediatric scoliotic patients instrumented with AVBGM were assessed. An osseoligamentous FEM of the spine, rib cage, and pelvis was generated before surgery using the patient's 3D reconstruction obtained from calibrated biplanar radiographs. For each case, different scenarios of AVBGM and two years of vertebral growth and growth modulation due to gravitational loads and forces from AVBGM were simulated. Simulated correction indices in the coronal, sagittal, and transverse planes for the retained scenario were computed and a posteriori compared to actual patient's postoperative and two years' follow-up data. RESULTS: The simulated immediate postoperative Cobb angles were on average within 3° of that of the actual correction, while it was ±5° for kyphosis/lordosis angles, and ±5° for apical axial rotation. For the simulated 2-year postoperative follow-up, correction results were predicted at ±3° for Cobb angles and ±5° for kyphosis/lordosis angles, ±2% for T1-L5 height, and ±4° for apical axial rotation. CONCLUSION: A numeric model simulating immediate and post-two-year effects of AVBGM enabled to assess different implant configurations to support surgical planning. LEVEL OF EVIDENCE: Level III.

Computer-assisted design and finite element simulation of braces for the treatment of adolescent idiopathic scoliosis using a coronal plane radiograph and surface topography.

BACKGROUND: Orthopedic braces made by Computer-Aided Design and Manufacturing and numerical simulation were shown to improve spinal deformities correction in adolescent idiopathic scoliosis while using less material. Simulations with BraceSim (Rodin4D, Groupe Lagarrigue, Bordeaux, France) require a sagittal radiograph, not always available. The objective was to develop an innovative modeling method based on a single coronal radiograph and surface topography, and assess the effectiveness of braces designed with this approach. METHODS: With a patient coronal radiograph and a surface topography, the developed method allowed the 3D reconstruction of the spine, rib cage and pelvis using geometric models from a database and a free form deformation technique. The resulting 3D reconstruction converted into a finite element model was used to design and simulate the correction of a brace. The developed method was tested with data from ten scoliosis cases. The simulated correction was compared to analogous simulations performed with a 3D reconstruction built using two radiographs and surface topography (validated gold standard reference). FINDINGS: There was an average difference of 1.4°/1.7° for the thoracic/lumbar Cobb angle, and 2.6°/5.5° for the kyphosis/lordosis between the developed reconstruction method and the reference. The average difference of the simulated correction was 2.8°/2.4° for the thoracic/lumbar Cobb angles and 3.5°/5.4° the kyphosis/lordosis. INTERPRETATION: This study showed the feasibility to design and simulate brace corrections based on a new modeling method with a single coronal radiograph and surface topography. This innovative method could be used to improve brace designs, at a lesser radiation dose for the patient.

3D correction over 2years with anterior vertebral body growth modulation: A finite element analysis of screw positioning, cable tensioning and postoperative functional activities.

BACKGROUND: Anterior vertebral body growth modulation is a fusionless instrumentation to correct scoliosis using growth modulation. The objective was to biomechanically assess effects of cable tensioning, screw positioning and post-operative position on tridimensional correction. METHODS: The design of experiments included two variables: cable tensioning (150/200N) and screw positioning (lateral/anterior/triangulated), computationally tested on 10 scoliotic cases using a personalized finite element model to simulate spinal instrumentation, and 2years growth modulation with the device. Dependent variables were: computed Cobb angles, kyphosis, lordosis, axial rotation and stresses exerted on growth plates. Supine functional post-operative position was simulated in addition to the reference standing position to evaluate corresponding growth plate's stresses. FINDINGS: Simulated cable tensioning and screw positioning had a significant impact on immediate and after 2years Cobb angle (between 5°-11°, p<0.01). Anterior screw positioning significantly increased kyphosis after 2years (6°-8°, p=0.02). Triangulated screw positioning did not significantly impact axial rotation but significantly reduced kyphosis (8°-10°, p=0.001). Growth plates' stresses were increased by 23% on the curve's convex side with cable tensioning, while screw positioning rather affected anterior/posterior distributions. Supine position significantly affected stress distributions on the apical vertebra compared to standing position (respectively 72% of compressive stresses on convex side vs 55%). INTERPRETATION: This comparative numerical study showed the biomechanical possibility to adjust the fusionless instrumentation parameters to improve correction in frontal and sagittal planes, but not in the transverse plane. The convex side stresses increase in the supine position may suggest that growth modulation could be accentuated during nighttime.

3D correction of AIS in braces designed using CAD/CAM and FEM: a randomized controlled trial.

BACKGROUND: Recent studies showed that finite element model (FEM) combined to CAD/CAM improves the design of braces for the conservative treatment of adolescent idiopathic scoliosis (AIS), using 2D measurements from in-brace radiographs. We aim to assess the immediate effectiveness on curve correction in all three planes of braces designed using CAD/CAM and numerical simulation compared to braces designed with CAD/CAM only. METHODS: SRS standardized criteria for bracing were followed to recruit 48 AIS patients who were randomized into two groups. For both groups, 3D reconstructions of the spine and patient's torso, respectively built from bi-planar radiographs and surface topography, were obtained and braces were designed using the CAD/CAM approach. For the test group, 3D reconstructions of the spine and patient's torso were additionally used to generate a personalized FEM to simulate and iteratively improve the brace design with the objective of curve correction maximization in three planes and brace material minimization. RESULTS: For the control group (CtrlBraces), average Cobb angle prior to bracing was 29° (thoracic, T) and 25° (lumbar, L) with the planes of maximal curvature (PMC) respectively oriented at 63° and 57° on average with respect to the sagittal plane. Average apical axial rotation prior to bracing was 7° (T) and 9° (L). For the test group (FEMBraces), initial Cobb angles were 33° (T) and 28° (L) with the PMC at 68° (T) and 56° (L) and average apical axial rotation prior to bracing at 9° (T and L). On average, FEMBraces were 50% thinner and had 20% less covering surface than CtrlBraces while reducing T and L curves by 47 and 48%, respectively, compared to 25 and 26% for CtrlBraces. FEMBraces corrected apical axial rotation by 46% compared to 30% for CtrlBraces. CONCLUSION: The combination of numerical simulation and CAD/CAM approach allowed designing more efficient braces in all three planes, with the advantages of being lighter than standard CAD/CAM braces. Bracing in AIS may be improved in 3D by the use of this simulation platform. This study is ongoing to recruit more cases and to analyze the long-term effect of bracing. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02285621.

Biomechanical Assessment of Providence Nighttime Brace for the Treatment of Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Biomechanical study of the Providence brace for the treatment of adolescent idiopathic scoliosis (AIS). OBJECTIVES: To model and assess the effectiveness of Providence nighttime brace. SUMMARY OF BACKGROUND DATA: Providence nighttime brace is an alternative to traditional daytime thoracolumbosacral orthosis for the treatment of moderate scoliotic deformities. It applies three-point pressure to reduce scoliotic curves. The biomechanics of the supine position and Providence brace is still poorly understood. METHODS: Eighteen patients with AIS were recruited at our institution. For each patient, a personalized finite element model (FEM) of the trunk was created. The spine, rib cage, and pelvis geometry was acquired using simultaneous biplanar low-dose radiographs (EOS). The trunk surface was acquired using a three-dimensional surface topography scanner. The interior surface of each patient's Providence brace was digitized and used to generate an FEM of the brace. Pressures at the brace/skin interface were measured using pressure sensors, and the average pressure distribution was computed. The standing to supine transition and brace installation were computationally simulated. RESULTS: Simulated standing to supine position induced an average curve correction of 45% and 48% for thoracic and lumbar curves, while adding the brace resulted in an average correction of 62% and 64% (vs. real in-brace correction of 65% and 70%). Simulated pressures had the same distribution as measured ones. Bending moments on apical vertebrae were mostly annulled by the positioning in the supine position, and further overcorrected on average by 10% to 13%, but in the opposite direction. CONCLUSIONS: The supine position is responsible for the major part of coronal curve correction, while the brace itself plays a complementary role. Bending moments induced by the brace generated a rebalancing of pressure on the growth plates, which could help reduce the asymmetric growth of the vertebrae. LEVEL OF EVIDENCE: Level II.

Braces Optimized With Computer-Assisted Design and Simulations Are Lighter, More Comfortable, and More Efficient Than Plaster-Cast Braces for the Treatment of Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Feasibility study to compare the effectiveness of 2 brace design and fabrication methods for treatment of adolescent idiopathic scoliosis: a standard plaster-cast method and a computational method combining computer-aided design and fabrication and finite element simulation. OBJECTIVES: To improve brace design using a new brace design method. SUMMARY OF BACKGROUND DATA: Initial in-brace correction and patient's compliance to treatment are important factors for brace efficiency. Negative cosmetic appearance and functional discomfort resulting from pressure points, humidity, and restriction of movement can cause poor compliance with the prescribed wearing schedule. METHODS: A total of 15 consecutive patients with brace prescription were recruited. Two braces were designed and fabricated for each patient: a standard thoracolumbo-sacral orthosis brace fabricated using plaster-cast method and an improved brace for comfort (NewBrace) fabricated using a computational method combining computer-aided design and fabrication software (Rodin4D) and a simulation platform. Three-dimensional reconstructions of the torso and the trunk skeleton were used to create a personalized finite element model, which was used for brace design and predict correction. Simulated pressures on the torso and distance between the brace and patient's skin were used to remove ineffective brace material situated at more than 6 mm from the patient's skin. Biplanar radiographs of the patient wearing each brace were taken to compare their effectiveness. Patients filled out a questionnaire to compare their comfort. RESULTS: NewBraces were 61% thinner and had 32% less material than standard braces with equivalent correction. NewBraces were more comfortable (11 of 15 patients) or equivalent to (4 of 15 cases) standard braces. Simulated correction was simulated within 5° compared with in-brace results. CONCLUSIONS: This study demonstrates the feasibility of designing lighter and more comfortable braces with correction equivalent to standard braces. This design platform has the potential to further improve brace correction efficiency and its compliance.