Minimum performance level definition for bone plate testing according to standard: A preliminary study

Terzini, Mara; Lugas, Andrea T.; Audenino, Alberto

doi:10.4081/bse.2021.154

Cited by 3 publications

(2 citation statements)

References 2 publications

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“…Over the years, many materials have been used to make bone plates, but titanium and stainless-steel alloys are popular ones. Titanium is exceptionally biocompatible, corrosion-resistance perfect for medical applications without any significant immune responses or allergic reactions [10,11]. The strength-to-weight ratio of titanium is renowned and its impressive strength and lightweight design, can be used in load-bearing applications.…”

Section: Introductionmentioning

confidence: 99%

A novel carbon‐flax bioepoxy hybrid composite bone plate with enhanced bio‐mechanical performance

Kennedy,

Arunachalam,

Kannan

2024

Materialwissenschaft Werkst

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This study aimed to pioneer a transformative approach in orthopedic implant design by developing and analyzing a groundbreaking carbon‐flax reinforced bioepoxy hybrid composite bone plate. The primary objectives of the present research were to enhance the bio‐mechanical performance of orthopedic implants and explore the potential applications of the novel material for orthopedic implants. Hybrid composite plate was fabricated mimicking the human bone with the soft inner core and a rigid outer coating. Mechanical properties for the hybrid composite were obtained through material characterization studies as per ASTM standards. The hybrid composite bone plates were tested as per bio‐mechanical test standard and the results were correlated with the finite element simulations. The maximum stress value in the experiments for the biomechanical four‐point bending tests was 331.74 MPa, and the corresponding strain value was 0.0337. The maximum equivalent stress and strain values obtained from simulation were in line with the findings of the experiments. The current research signifies a paradigm shift in orthopedic implant technology. The carbon‐flax bioepoxy hybrid composite offers remarkable potential for orthopedic applications, promising safer and more durable solutions for patients in need of bone repair or replacement.

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Section: Introductionmentioning

confidence: 99%

A novel carbon‐flax bioepoxy hybrid composite bone plate with enhanced bio‐mechanical performance

Kennedy,

Arunachalam,

Kannan

2024

Materialwissenschaft Werkst

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“…Strategies based on Finite Element (FE) analyses are usually proposed to study the effect of a hole [ 4 , 16 , 27 ] or a notch [ 26 ] in the stress distribution of a bone plate. Moreover, FE analyses are often used for the calculation of the stress distribution in a static condition, to be inserted into commercial software for the evaluation of fatigue life through analytical methods [ 1 , 7 ].…”

Section: Introductionmentioning

confidence: 99%

Bone Plates Runout Prediction Through Tensile Strength and Geometric Properties for Regulatory Mechanical Testing

Bologna,

Audenino,

Terzini

2023

Ann Biomed Eng

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Mechanical tests on bone plates are mandatory for regulatory purposes and, typically, the ASTM F382 standard is used, which involves a four-point bending test setup to evaluate the cyclic bending fatigue performance of the bone plate. These test campaigns require a considerable financial outlay and long execution times; therefore, an accurate prediction of experimental outcomes can reduce test runtime with beneficial cost cuts for manufacturers. Hence, an analytical framework is here proposed for the direct estimation of the maximum bending moment of a bone plate under fatigue loading, to guide the identification of the runout load for regulatory testing. Eleven bone plates awaiting certification were subjected to a comprehensive testing campaign following ASTM F382 protocols to evaluate their static and fatigue bending properties. An analytical prediction of the maximum bending moment was subsequently implemented based on ultimate strength and plate geometry. The experimental loads obtained from fatigue testing were then used to verify the prediction accuracy of the analytical approach. Results showed promising predictive ability, with R2 coefficients above 0.95 in the runout condition, with potential impact in reducing the experimental tests needed for the CE marking of bone plates.

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An analytical and in silico strategy for estimating maximum stress and fatigue life of bone plates under in vivo loads: a rationale for regulatory testing

Bologna,

Audenino,

Terzini

2023

Front. Med. Eng.

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Despite the innovations introduced by locking compression plates (LCP), implant failures still occur due to fatigue fractures caused by cyclic loads. The endurance of LCP, especially in lower limb plates subjected to ambulatory cyclic loads, is a critical factor that needs to be understood. Unfortunately, there is limited information available on the fatigue failure of LCP. The fatigue behavior is a crucial aspect of mandatory mechanical tests for regulatory purposes, which aim to determine the load at which the plate withstands under a specific number of cycles, known as the runout condition. The current test standards, such as ASTM F382, only provide the setup configuration without furnishing explicit guidelines regarding the required fatigue strength of the bone plate in the runout condition. The determination of the minimum level of in vivo performance that the plate must fulfill remains an open issue, which is frequently addressed by the direct comparison with predicate devices. To address this issue, this study proposes a rationale that combines analytical and in silico approaches to estimate the maximum stress and fatigue life of a bone plate under in vivo loads. Four-point bending tests were conducted on a diaphyseal femoral plate to determine the experimental runout load. Analytical and finite element (FE) models were first implemented to replicate the four-point bending setup and to calculate the maximum stress on the plate. The Goodman and Gerber criteria were exploited to determine the mean stress effect due to the four-point bending setup and to verify the predicted number of cycles. In addition, the force-displacement curves of the FE model were validated by means of experimental results. Analytical and FE models were then applied to calculate the maximum stress and assess the performance of the implanted plate under in vivo loading conditions. In the implanted plate condition, a mean number of cycles higher than 1.5 million was estimated. Analytical models showed good performance compared with in silico strategies, exhibiting errors below 6%. The comparison between the obtained results provides valuable insights for constructing a robust rationale to support the regulatory process in order to obtain CE marking.

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Minimum performance level definition for bone plate testing according to standard: A preliminary study

Cited by 3 publications

References 2 publications

A novel carbon‐flax bioepoxy hybrid composite bone plate with enhanced bio‐mechanical performance

A novel carbon‐flax bioepoxy hybrid composite bone plate with enhanced bio‐mechanical performance

Bone Plates Runout Prediction Through Tensile Strength and Geometric Properties for Regulatory Mechanical Testing

An analytical and in silico strategy for estimating maximum stress and fatigue life of bone plates under in vivo loads: a rationale for regulatory testing

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