Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard.

Computational modeling and simulation (CM&S) is a key tool in medical device design, development, and regulatory approval. For example, finite element analysis (FEA) is widely used to understand the mechanical integrity and durability of orthopaedic implants. The ASME V&V 40 standard and supporting FDA guidance provide a framework for establishing model credibility, enabling deeper reliance on CM&S throughout the total product lifecycle. Examples of how to apply the principles outlined in the ASME V&V 40 standard are important to facilitating greater adoption by the medical device community, but few published examples are available that demonstrate best practices. Therefore, this paper outlines an end-to-end (E2E) example of the ASME V&V 40 standard applied to an orthopaedic implant. The objective of this study was to illustrate how to establish the credibility of a computational model intended for use as part of regulatory evaluation. In particular, this study focused on whether a design change to a spinal pedicle screw construct (specifically, the addition of a cannulation to an existing non-cannulated pedicle screw) would compromise the rod-screw construct mechanical performance. This question of interest (?OI) was addressed by establishing model credibility requirements according to the ASME V&V 40 standard. Experimental testing to support model validation was performed using spinal rods and non-cannulated pedicle screw constructs made with medical grade titanium (Ti-6Al-4V ELI). FEA replicating the experimental tests was performed by three independent modelers and validated through comparisons of common mechanical properties such as stiffness and yield force. The validated model was then used to simulate F1717 compression-bending testing on the new cannulated pedicle screw design to answer the ?OI, without performing any additional experimental testing. This E2E example provides a realistic scenario for the application of the ASME V&V 40 standard to orthopedic medical device applications.

Computational and Experimental Fatigue Analysis of Contoured Spinal Rods.

Posterior fixation with contoured rods is an established methodology for the treatment of spinal deformities. Both uniform industrial preforming and intraoperative contouring introduce tensile and compressive plastic deformations, respectively, at the concave and at the convex sides of the rod. The purpose of this study is to develop a validated numerical framework capable of predicting how the fatigue behavior of contoured spinal rods is affected by residual stresses when loaded in lordotic and kyphotic configurations. Established finite element models (FEM) describing static contouring were implemented as a preliminary simulation step and were followed by subsequent cyclical loading steps. The equivalent Sines stress distribution predicted in each configuration was compared to that in straight rods (SR) and related to the corresponding experimental number of cycles to failure. In the straight configuration, the maximum equivalent stress (441 MPa) exceeds the limit curve, as confirmed by experimental rod breakage after around 1.9 × 105 loading cycles. The stresses further increased in the lordotic configuration, where failure was reached within 2.4 × 104 cycles. The maximum equivalent stress was below the limit curve for the kyphotic configuration (640 MPa), for which a run-out of 106 cycles was reached. Microscopy inspection confirmed agreement between numerical predictions and experimental fatigue crack location. The contouring technique (uniform contouring (UC) or French bender (FB)) was not related to any statistically significant difference. Our study demonstrates the key role of residual stresses in altering the mean stress component, superposing to the tensile cyclic load, potentially explaining the higher failure rate of lordotic rods compared to kyphotic ones.

The growth-friendly surgical treatment of scoliosis in children with osteogenesis imperfecta using distraction-based instrumentation.

PURPOSE: The study was undertaken to determine the feasibility of growth-friendly distraction-based surgery in children with OI. METHODS: Two multi-center databases were queried for children with OI who had undergone GR or VEPTR surgery. Inclusion criteria were a minimum 2-year follow-up and three lengthening procedures following the initial implantation. Details of the surgical techniques, surgical complications, and radiographic measurements of deformity correction, T1-T12 and T1-S1 elongation and growth were recorded. RESULTS: Five patients were identified. There was one patient with type I OI and two patients each with type III and type IV. Four patients had GR constructs and one a VEPTR construct. The initial scoliosis deformity averaged 80° (70°-103°), and the subsequent corrections averaged 32% for initial correction, 48% at last follow-up, and 54% for the two patients that had a final fusion. The T1-T12 and T1-S1 growth averaged 31 mm and 44 mm respectively, and yearly growth averaged 4 mm and 6 mm, respectively. Growth was notably much less in those with more severe disease. There were 13 complications in 4 patients. Nine of the 10 surgical complications were anchor failures which were corrected in 7 planned and 2 un-planned procedures. Significant migration occurred in one patient with severe OI type III. CONCLUSION: The results varied in this heterogeneous population. In general, satisfactory deformity corrections were obtained and maintained, modest growth was obtained, and complications were similar to those reported in other series of growth-friendly surgery. Limited growth and significant anchor migration are to be anticipated in this population. LEVEL OF EVIDENCE: IV.

Spinal rod gripping capacity: how do 5.5/6.0-mm dual-diameter screws compare?

STUDY DESIGN: Biomechanical comparative study. OBJECTIVE: To evaluate pedicle screw gripping capacity from five suppliers, comparing single-diameter (S-D) systems using 5.5-mm-diameter rods to dual-diameter (D-D) systems accepting 5.5- and 6.0-mm-diameter rods with both cobalt chromium (CoCr) and titanium alloy (Ti) rods. D-D systems have become increasingly prevalent; however, these systems theoretically may compromise spinal rod gripping, particularly when a smaller-diameter rod is used within a D-D pedicle screw. METHODS: D-D pedicle screw systems from three suppliers (accepting 5.5- and 6.0-mm-diameter, Ti and CoCr rods), and S-D systems from two suppliers (accepting 5.5-mm-diameter, Ti and CoCr rods) were tested on an MTS MiniBionix machine. Axial load was applied in line with the rod to measure axial gripping capacity (AGC), and torsional load was applied to measure torsional gripping capacity (TGC) for each rod material and diameter. AGC and TGC were compared between D-D and S-D constructs, suppliers, rod diameters, and materials with subsequent classification and regression tree (CART) analysis. RESULTS: 5.5-mm rods within D-D screws were no weaker than 5.5-mm rods in S-D systems for AGC (dual > single, p = 0.043) and TGC (p = 0.066). As a whole, D-D systems had greater AGC than S-D systems (p = 0.01). AGC differed between suppliers (p < 0.001). No rod diameter (p = 0.227) or material (p = 0.131) effect emerged. With CART analysis, Supplier was the most significant predictor for greater AGC. As a whole, D-D systems had greater TGC than S-D systems (p = 0.008). TGC differed between suppliers (p < 0.001). Rod diameter was a significant predictor of higher TGC (6.0 > 5.5 mm, p = 0.002). CoCr rods had greater TGC than Ti (p < 0.001). CART analysis revealed that Supplier and CoCr material were significant predictors for increased TGC. CONCLUSIONS: Despite 30%-70% variability in gripping capacity due to rod supplier and material, overall D-D pedicle screw systems had similar AGC and TGC as S-D systems. LEVEL OF EVIDENCE: N/A.