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Low Elastic Modulus Titanium Alloy Pedicle Screws Reduce the Risk of Screw Loosening: A Pre-Clinical Biosafety and Biomechanical Evaluation - 05/11/25

Doi : 10.1016/j.otsr.2025.104547 
Jinhui Liu a, 1, Wenqiang Xu b, 1, Lijunpeng Jia c, 1, Weiye Cai b, Longlong Zhang c, Ke Duan a, Yang Liu d, Jingchi Li c, d, , 1
a Sichuan Provincial Laboratory of Orthopaedic Engineering, Department of Bone and Joint Surgery, Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan Province, P.R. China 
b Department of Orthopaedics, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, 210028, Jiangsu Province, P.R. China 
c Department of Orthopedics, Luzhou Key Laboratory of Orthopedic Disorders, The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou, 646000, Sichuan Province, P.R. China 
d Department of Spine Surgery, Shanghai Changzheng Hospital, Naval Medical University, Shanghai, P.R. China 

Corresponding author.
In corso di stampa. Prove corrette dall'autore. Disponibile online dal Wednesday 05 November 2025

Abstract

Background

The exacerbation of interfacial stiffness differences can lead to localized stress concentration and an increased incidence of pedicle screw loosening. Consequently, the etiology behind the higher occurrence of screw loosening in osteoporotic patients stems not only from a reduction in bone strength but also from a progressive decline in bone elastic modulus. In this context, we hypothesize that constructing pedicle screws using materials with low elastic modulus may help mitigate stiffness discrepancies at the bone-screw interface, potentially serving as an alternative biomechanical strategy to reduce the incidence of screw loosening.

Methods

In vitro experiments were conducted to evaluate the biosafety of the novel low elastic modulus titanium alloy, Ti2448. This assessment was performed through various methods including the CCK-8 assay, flow cytometry, live and dead cell staining, and lactate dehydrogenase detection. In-vivo insertion of Ti2448 block have also been performed to assess whether it caused a local inflammatory response. Subsequently, conventional and low elastic modulus titanium alloy pedicle screws with identical shapes are machined. A comprehensive biomechanical study, comprising mechanical tests and numerical simulations, was conducted using an osteoporotic test block to evaluate the impact of reduced differences in bone-screw interfacial stiffness on local stress distribution and screw anchorage capability.

Results

The ideal biosafety of the Ti2448 has been demonstrated through both in vitro and in vivo examinations. Furthermore, when compared to traditional titanium alloy, screws with a low elastic modulus exhibit superior anchorage capabilities in mechanical testing. Correspondingly, mechanical simulations indicate that the low elastic modulus screw can reduce interfacial stiffness differences, thereby alleviating stress concentration at the bone-screw interface.

Conclusions

Low elastic modulus titanium alloy pedicle screws, characterized by their excellent biosafety, represent a viable alternative for the internal fixation of osteoporotic patients. This innovative approach aims to minimize interfacial stress concentration and mitigate the risk of screw loosening.

Level of evidence

IV; basic science and biomechanical study.

Il testo completo di questo articolo è disponibile in PDF.

Keywords : Screw loosening, Interfacial stress concentration, Stiffness difference, Pedicle screw, Low elastic modulus titanium alloy


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