Estimating safety factor for femoral plates subjected to in vivo loads
Fatigue behaviour is a crucial aspect of mandatory mechanical tests for regulatory purposes, aimed at determining the load at which the bone plate withstands under a specific number of cycles, known as the runout condition. However, current test standards, such as ASTM F382, provide setup configurat...
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| Format: | Article |
| Language: | English |
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De Gruyter
2024-12-01
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| Series: | Current Directions in Biomedical Engineering |
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| Online Access: | https://doi.org/10.1515/cdbme-2024-2025 |
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| _version_ | 1846096971184472064 |
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| author | Bologna Federico Andrea Audenino Alberto Luigi Terzini Mara |
| author_facet | Bologna Federico Andrea Audenino Alberto Luigi Terzini Mara |
| author_sort | Bologna Federico Andrea |
| collection | DOAJ |
| description | Fatigue behaviour is a crucial aspect of mandatory mechanical tests for regulatory purposes, aimed at determining the load at which the bone plate withstands under a specific number of cycles, known as the runout condition. However, current test standards, such as ASTM F382, provide setup configurations without explicit guidelines on required fatigue strength. The determination of the minimum level of in vivo performance that the plate must fulfil remains an open issue, which is frequently addressed by the direct comparison with predicate devices. To address this gap, this study proposes an in silico framework to estimate maximum stress on implanted femoral plates for comparison with four-point bending tests described in the ASTM standard, deriving appropriate safety factors. As case studies, three femoral plates were assessed, and results showed safety factors above 1.1, indicating the reliability of the implanted plates. |
| format | Article |
| id | doaj-art-bc90e32bfae147a994891f15f5dac541 |
| institution | Kabale University |
| issn | 2364-5504 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | De Gruyter |
| record_format | Article |
| series | Current Directions in Biomedical Engineering |
| spelling | doaj-art-bc90e32bfae147a994891f15f5dac5412025-01-02T05:56:32ZengDe GruyterCurrent Directions in Biomedical Engineering2364-55042024-12-0110410310610.1515/cdbme-2024-2025Estimating safety factor for femoral plates subjected to in vivo loadsBologna Federico Andrea0Audenino Alberto Luigi1Terzini Mara2Politecnico di Torino,Turin, ItalyPolitecnico di Torino,Turin, ItalyPolitecnico di Torino,Turin, ItalyFatigue behaviour is a crucial aspect of mandatory mechanical tests for regulatory purposes, aimed at determining the load at which the bone plate withstands under a specific number of cycles, known as the runout condition. However, current test standards, such as ASTM F382, provide setup configurations without explicit guidelines on required fatigue strength. The determination of the minimum level of in vivo performance that the plate must fulfil remains an open issue, which is frequently addressed by the direct comparison with predicate devices. To address this gap, this study proposes an in silico framework to estimate maximum stress on implanted femoral plates for comparison with four-point bending tests described in the ASTM standard, deriving appropriate safety factors. As case studies, three femoral plates were assessed, and results showed safety factors above 1.1, indicating the reliability of the implanted plates.https://doi.org/10.1515/cdbme-2024-2025osteosynthesis device testingastm f382four-point bendingimplanted platesafety factor |
| spellingShingle | Bologna Federico Andrea Audenino Alberto Luigi Terzini Mara Estimating safety factor for femoral plates subjected to in vivo loads Current Directions in Biomedical Engineering osteosynthesis device testing astm f382 four-point bending implanted plate safety factor |
| title | Estimating safety factor for femoral plates subjected to in vivo loads |
| title_full | Estimating safety factor for femoral plates subjected to in vivo loads |
| title_fullStr | Estimating safety factor for femoral plates subjected to in vivo loads |
| title_full_unstemmed | Estimating safety factor for femoral plates subjected to in vivo loads |
| title_short | Estimating safety factor for femoral plates subjected to in vivo loads |
| title_sort | estimating safety factor for femoral plates subjected to in vivo loads |
| topic | osteosynthesis device testing astm f382 four-point bending implanted plate safety factor |
| url | https://doi.org/10.1515/cdbme-2024-2025 |
| work_keys_str_mv | AT bolognafedericoandrea estimatingsafetyfactorforfemoralplatessubjectedtoinvivoloads AT audeninoalbertoluigi estimatingsafetyfactorforfemoralplatessubjectedtoinvivoloads AT terzinimara estimatingsafetyfactorforfemoralplatessubjectedtoinvivoloads |