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Wear and corrosion of titanium alloy spinal implants in vivo | Scientific Reports

Oct 14, 2024Oct 14, 2024

Scientific Reports volume 14, Article number: 16847 (2024) Cite this article

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To investigate the wear and corrosion of titanium alloy spinal implants in vivo, we evaluated removed implants and their surrounding scar tissues from 27 patients between May 2019 and April 2021. We performed scanning electron microscopy, energy-dispersive X-ray spectroscopy, and histological analysis. The results revealed metal-like particles in the soft tissues of seven patients, without any considerable increase in inflammatory cell infiltration. Patients with fractures showed lower percentages of wear and corrosion compared with other patients (42% and 17% vs. 59% and 26%). Polyaxial screws exhibited higher wear and corrosion percentages (53% and 23%) compared with uniaxial screws (39% and 3%), although in patients with fracture, the reverse was observed (20% and 0% vs. 39% and 3%). We found that titanium alloy spinal implants experience some degree of wear and corrosion in vivo. The titanium alloy particles formed by wear exhibited good histocompatibility, not causing inflammation, foreign body reactions, or osteolysis. Therefore, spinal implants should be removed cautiously when treating titanium alloy spinal metallosis. The wear and corrosion of the implants increase with the increase in implantation time, although the screw structure does not significantly affect these changes.

Implants, such as plates, artificial joint prostheses, pedicle screws, and rods, are widely used in orthopedic surgeries. These implants are prepared using various materials, including stainless steel, titanium alloy, cobalt–chromium CoCrMo alloy, and polyethylene. Previous studies have shown that metal implants undergo varying degrees of wear and corrosion in vivo, leading to major consequences1,2,3,4. As the implantation time of the artificial joint prosthesis increases, the metal particles released by wear and corrosion can reduce the service life of the implant, affecting the patient’s condition, short-term inflammatory response around the implant, and the dissolution of artificial joint bone5,6,7. Hence, studying the wear and corrosion status of implants in vivo is essential for maintaining the therapeutic efficacy of implants and providing guidelines for timely replacement to maintain patient health.

Currently, pedicle screws and rods are the most commonly used implants in spine surgery. Previous studies have indicated that pedicle screws and rods made of stainless steel exhibit significant wear and corrosion in the body, resulting in metal particles in surrounding tissues and subsequent inflammatory reactions8. As titanium alloy is a more stable metal, it has gradually replaced stainless steel as the material of choice for spinal implants9. However, it remains unclear whether titanium spinal implants cause wear and corrosion in the body, producing free titanium particles that could lead to adverse reactions such as inflammation and allergic reactions. Metal artificial joints are known to cause osteolysis, which can lead to the loosening of spinal implants and major complications such as broken screws, broken rods, nerve damage, and failed intervertebral fusion. Therefore, investigating the in vivo performance of titanium implants is crucial for evaluating the rehabilitation status of patients.

In this study, we investigated the wear and corrosion of titanium implants and the complications due to the release of titanium particles in vivo, including inflammation, foreign body reaction, and osteolysis. We aimed to understand how the wear and corrosion of implants contribute to osteolysis and aseptic loosening of the spine.

In this study, 27 patients were enrolled, which included 18 males and 9 females. The main diseases included thoracolumbar fracture, adjacent segment disease after lumber fusion, and lumbar spondylolisthesis. In total, 15 patients were present with thoracolumbar fracture, 11 patients with adjacent segment disease, and one patient with lumbar spondylolisthesis. No signs of infection and loosening or fracture of the spinal implants were observed during the preoperative imaging examination and operation process.

Soft tissue scars were collected from 27 patients and stained with hematoxylin and eosin (H&E). The results indicated that the soft tissues of seven patients contained metal-like particles but did not exhibit a significant increase in the infiltration of inflammatory cells. Among the patients with soft tissues containing metal particles, five were diagnosed with adjacent segment disease, whereas two were diagnosed with thoracolumbar fractures. These metal-containing soft tissues were primarily found around the junction of the pedicle screws and rods (Fig. 1, Table 1). X-rays indicated that the implants were securely fixed in the spine and remained morphologically intact (Fig. 1a). To determine the composition of these metal particles, we further determined the soft tissues using scanning electron microscopy (SEM) and energy dispersive X-ray spectroscopy (EDX) measurements. The results revealed that these metal particles were mainly composed of titanium (approximately 80%) and aluminum (approximately 5%), which is consistent with the manufacturer’s data on the composition of the spinal implants (TI-6AL-4 V) (Fig. 2). However, vanadium was not detected, the cause of which remains unclear.

Changes of titanium alloy implants morphology and soft tissue pathology after implantation. (a) X-rays were used to observe the morphology of the implant. (b) Soft tissue scar around the implants. (c,d) showed metal particles could be found in the soft tissue surrounding some spinal implants in HE, but there was no significant increase in the inflammatory cells infiltration. Red arrows indicated inflammatory cells, dotted lines indicated the location of the implant, and the black around * indicated titanium metal. 100 × magnification.

Component analysis in soft tissues. The metal particles in soft tissues were mainly composed of titanium and aluminum, which was consistent with the data provided by the manufacturer on the composition of their spinal implants (TI-6AL-4 V).

In total, 102 polyaxial pedicle screws, 72 uniaxial pedicle screws, and 54 rods were removed for analysis. These spinal implants were carefully observed, and those with distinct surface changes underwent further examination with SEM and EDX. The results confirmed that the pedicle screws and rods were composed of titanium alloy, consistent with the information provided by the manufacturer (TI-6AL-4 V) (Fig. 3).

Component analysis in the titanium alloy implant. A lot of scratches could be seen on the surface of the retrieved screws. EDX indicated its main components were titanium and aluminum, which was consistent with the data provided by the manufacturer (TI-6AL-4 V).

Two types of pedicle screws are commonly used, namely polyaxial and uniaxial screws. Among the samples containing metal particles, nine were from patients diagnosed with adjacent segment disease who had polyaxial pedicle screws, and two were from patients with thoracolumbar fractures who had uniaxial pedicle screws. The results indicated that 54 of 102 polyaxial pedicle screws were worn (wear percentage: 53%) and 24 of 102 screws were corroded (corrosion percentage: 23%). Furthermore, 28 of 27 uniaxial screws were worn (wear percentage: 39%) and 2 of 72 were corroded (corrosion percentage: 3%). Thus, the wear and corrosion percentages of polyaxial screws were higher than those of uniaxial screws (Fig. 4).

Comparison of wear and corrosion percentages in polyaxial and uniaxial screws. (a) is uniaxial screws, (b) is polyaxial screws. It could be seen that in terms of wear percentage and corrosion percentage, polyaxial screws were higher than uniaxial screws. But in patients with spinal fractures,the results showed that the wear percentage and corrosion percentage of uniaxial screws were higher than those of polyaxial screws (c,d).

To investigate if the wear and corrosion percentages of the two types of screws were different due to the structural differences at the same implantation time, we compared the two types of pedicle screws in patients with spinal fractures. The results indicated that the wear percentage (28/72, 39%) and corrosion percentage (2/72, 3%) of uniaxial screws were higher than those of polyaxial screws (6/30, 20% vs. 0/30, 0%). Additionally, the locations of wear and corrosion of screws were primarily at both ends of the rods. Of the 54 rods, 35 rods were worn and 13 rods were corroded. Furthermore, the corroded parts were also mainly located at both ends of the rods. No significant difference was found in the wear percentage and corrosion percentage between long and short rods (Fig. 5, Table 2).

Comparison of wear and corrosion percentages in different types of implants. (a–c) showed the locations of wear and corrosion of spinal implants were mainly at the ends of the rods. There was no significant difference in wear percentage and corrosion percentage between long and short rods.

Additionally, we found that wear and corrosion percentages increased with increasing implantation time for both uniaxial and polyaxial screws, which is similar in rods. Of the seven patients, two patients with fractures were implanted less than 20 months ago. Additionally, the percentages of wear and corrosion were 42% (5/12) and 17% (2/12), respectively. However, in the other five patients, the implant time was more than 33 months and the wear percentage and corrosion percentage were 59% (20/34) and 26% (9/34), respectively.

Orthopedic implants are primarily composed of several types of metals, which form metal particles upon wear. Previous studies have reported that wear particles can stimulate inflammatory cells to secrete a large number of osteolytic factors, including tumor necrosis factor (TNF-α) and interleukins (ILs) such as IL-1 and IL-6. These osteolytic factors can activate osteoclasts, stimulate osteolysis, and ultimately lead to the aseptic loosening of implants, such as artificial joint prostheses5,9,10. Our findings suggest that as the implantation time increases, the proportion of wear and corrosion of titanium alloy implants also increases. Notably, wear and corrosion can occur gradually with the implantation of titanium alloy pedicle screws and rods. Nevertheless, the exact timing of the wear is not known. It may occur sooner than expected, potentially releasing metal ions after the oxide layer on the implant surface is destroyed. In the present study, no distinct inflammation or foreign body reaction was observed in the tissues surrounding the implant irrespective of the amount of titanium particles entering these tissues, which is inconsistent with the previous findings of the wear of stainless-steel spinal implants in vivo8. We hypothesize that this may be associated with the good tissue compatibility of titanium alloys. Even though they also produce a high number of wear particles in vivo, they do not trigger the aggregation of inflammatory cells or release inflammatory mediators11,12,13,14,15. Additionally, the activity of osteoclasts and osteolysis does not increase considerably.

By characterizing the pedicle screws and rods, we observed that they had different degrees of wear, mainly at the joint. Similar to the presentation of wear, corrosion was mainly present at the joint of screws and rods. We hypothesized that corrosion occurs due to the slight movement between the screws and rods. Additionally, this continuous slight movement destroys the oxide film on the surface of the titanium alloy, causing direct exposure of the metal to body fluids and ultimately causing corrosion. This corrosion, also known as fretting corrosion, is the most prevalent type of corrosion in spinal implants16,17,18. Additionally, mild scratches and wear were observed in the middle part of some rods, and subsequent evaluation of these rods showed no signs of corrosion. Furthermore, no metal particles of titanium alloy were detected in the surrounding soft tissue. We assumed that the mild scratches and wear may be due to the scraping of surgical instruments and screws during the process of rod installation and removal. Based on these aforementioned results, we concluded that persistent fretting can be one of the crucial factors leading to the wear and corrosion of titanium alloy screws and rods.

Many other factors lead to the wear and corrosion of spinal internal fixators, including the structure and material of the implants19. Previous studies on the structure of spinal implants have mainly focused on the differences between long and short rods and special implants, such as isola20,21. Hence, we evaluated the rods based on these factors. Inconsistent with the results of previous studies, our findings suggest that wear and corrosion of the long and short rods mainly occurred at the points of contact with the screws, especially at the ends of these rods. Additionally, no significant difference was found between the long and short rods. Because our study primarily focused on spinal fractures and degenerative diseases, we did not consider long-segment fixed rods in deformity correction surgery for comparative analysis. Consequently, the difference in length between the long and short rods was not significant.

Currently, two types of pedicle screws, namely uniaxial pedicle screws and polyaxial pedicle screws, are commonly used. The tail and body of the uniaxial screw as a whole can move only in the same plane. Conversely, the tail and body of the polyaxial screw are movable connections that allow multi-axis rotation. Polyaxial pedicle screws contain a fretting joint, which may increase wear and fretting corrosion between the screws and the rod or even loosen the implants. A few studies have investigated the effect of the structures of pedicle screws on the wear and corrosion of implants. Therefore, herein, we further examined the effect of these two types of pedicle screws and showed that the wear and corrosion percentages of polyaxial pedicle screws were higher than those of uniaxial pedicle screws. The majority of polyaxial pedicle screws showing signs of corrosion were obtained from patients with adjacent segment disease, which were present in the body for more than 40 months, suggesting the effect of implantation time on wear and corrosion. Uniaxial pedicle screws are mainly used for patients with thoracolumbar fractures and are often removed after fracture healing, at around 12–18 months, which is not a long retention time. Herein, pedicle screws of patients with thoracolumbar fractures were selected to determine the effect of the pedicle screw structure on the wear and corrosion of implants, and the effect of implantation time was excluded from this assessment. The results showed that the wear and corrosion percentages of the uniaxial pedicle screws were higher than those of the polyaxial pedicle screws, which are inconsistent with the previous results. Therefore, we examined the positions of these screws and showed that the corroded screws were mainly positioned at the ends of the rod. We postulated that the greater the stress at both ends of the rod, the greater the stress on the screws and the more enhanced the wear and corrosion. With the same type of screw, screws located at both ends of the rod showed a higher percentage of corrosion. Finally, we revealed that persistent fretting and stress were the key reasons behind wear and corrosion and not the pedicle screw structure.

In addition to fretting and stress, galvanic pitting and crevice corrosion are considered important factors in wear and corrosion. Additionally, the corrosion mechanism is independent of local microorganisms. However, the wear and corrosion of the transplanted Ti6Al4V spinal rod may be related to microbial corrosion22. For instance, when anaerobic sulfur-reducing bacteria are present in and on human tissues, the corrosion observed on a graft is most likely because of microbial corrosion rather than other physiological processes such as inflammation22. Herein, whether the wear and corrosion of titanium alloy implants were associated with these factors was further determined. Implant coatings can improve wear and corrosion resistance, thereby effectively preventing the release of metal ions and particles and improving their performance. For instance, TaZrN coating on CoCrMo alloy shows better wear and corrosion resistance, thus extending the service life of hip implants23. Commercially available existing implant coatings include titanium nitride (TiN), titanium niobium nitride (TiNbN), oxidized zirconium (OxZr), and zirconium nitride (ZrN)24. Hence, coated implants can be an alternative to uncoated metal implants, especially for patients with metal allergies.

Metal implants release metal ions owing to wear and corrosion in vivo, and these metal ions form metal particles and trigger a series of changes, such as the discoloration of the surrounding soft tissues, known as metallosis20,25. Herein, a large amount of metal particles were detected in the surrounding soft tissues; however, no soft tissue discoloration was observed. Currently, no clear guidelines have been established for the treatment of spinal metallosis. Some surgeons recommend removing all internal fixators even if there are no loose internal fixators once metallosis is diagnosed20,26. However, we showed that the titanium alloys did not induce osteolysis, implant loosening, and fractures. Therefore, we primarily considered the clinical symptoms of the patient when devising a treatment plan. Additionally, in the absence of spinal instability or adjacent segment disease, spinal fixation removal was not recommended.

In conclusion, the titanium alloy spinal implants underwent a certain degree of wear and corrosion in vivo. The titanium alloy particles formed by wear showed good histocompatibility and did not elicit inflammation, foreign body reactions, or osteolysis. Nonetheless, spinal implants were removed with caution when treating titanium-alloy-induced spinal metallosis. With the increasing implantation time, the wear and corrosion of the implants increased correspondingly; however, the structure of the screws and the length of the rod did not affect the wear and corrosion.

Patients who underwent implant removal in the Department of Spine Surgery of ZhongDa Hospital of Southeast University from May 2019 to April 2021 were included in the present study. The inclusion criteria were as follows: 1. Patients were of either sex and between the ages of 18 and 75 years. 2. They underwent their initial surgery in our hospital and needed to remove the spinal implant for various reasons. 3. No complications such as wound infection or inflammation around the implant were observed during the perioperative period. This study was approved by the ethics review committee of ZhongDa Hospital of Southeast University, and all patients signed the informed consent form (2019ZDSYLL068). All experiments were performed in accordance with relevant guidelines and regulations. During the surgery, soft tissue scars adjacent to the screws and the rod were cut, and the implant was removed gently to avoid damage to the implants by friction. During installing and removing the screws and the rod, surgical instruments inevitably collided and caused friction with the screw tails; hence, the part of the screw tail in contact with the nail instrument was not considered within our detection range. The presence of visible scratches on the rod surface, especially the wear caused by the rod during pre-bending, was considered an unavoidable surgical procedure and was not included in the scope of the study. The mentioned soft tissues and implants were collected and used as specimens for testing. All spinal implants were provided by China Weigao Instrument Co., Ltd.

The pedicle screws and rod were removed and confirmed by three surgeons involved in the surgery. Soft tissue scars around 5 mm of the implants were excised, soaked in 10% formalin, and labeled separately for subsequent testing.

The soft tissues were fixed with 10% neutral-buffered formalin, dehydrated, embedded in paraffin, cut into slices of 7 μm in thickness, and stained with H&E. By performing H&E staining, we observed and evaluated the infiltration of inflammatory cells to determine the presence of inflammation and foreign body reactions in the soft tissues.

The soft tissues were washed twice with phosphate-buffered saline (PBS) and fixed overnight with 2.5% glutaraldehyde phosphate buffer at 0–4 °C. The resulting samples were washed twice with PBS at 4 °C, fixed with 1% osmic acid for 2 h, washed twice with PBS again, dehydrated stepwise using gradient alcohol (30%, 50%, 70%, 80%, 90%, 95%, and 100%), and dried at the critical point after replacing isoamyl acetate. The samples were then examined by SEM (Hitachi S-3400 N) after surface gold spraying and conducting a treatment.

We analyzed metal particle composition in the soft tissues to determine whether the metal particles were released by the spinal implants. The soft tissues containing these metal particles, identified using SEM, were further subjected to EDX (Oxford Instruments). The main elements were identified, the composition was determined, and the results were compared with those of the component elements of the spinal implants.

All pedicle screws and the rod were provided by China Weigao Equipment Co., Ltd. According to the data provided by the manufacturer, these spinal implants mainly comprised Ti-6Al-4 V alloy. During the procedure, the same surgeons removed these implants using surgical instruments and avoided unnecessary scratching among the instruments, the pedicle screws, and the rod. The removed implants were washed with 3% hydrogen peroxide, brushed with a mild detergent, and then analyzed as follows.

The retrieved pedicle screws and rod were preliminarily observed by three researchers unrelated to the present study. The implants were considered worn when scratches were clearly observed on their surfaces. Implants with surface wear and other abnormal changes were further analyzed by SEM (Hitachi S-3400 N) to check for signs of corrosion. The degree of corrosion was identified using the Higgs–Goldberg method27. Briefly, corrosion was identified as white haziness (indicative of intergranular crevice corrosion), discoloration, and/or blackened debris. The following formula was used to calculate corrosion or wear proportion.

The retrieved spinal implants were examined by EDX (Oxford Instruments) to confirm their elemental composition. The consistency of the material was confirmed by comparing the obtained data with data provided by the manufacturer. Additionally, the origin of the metal particles observed in the soft tissue was confirmed.

SPSS 25.0 was used for statistical analysis. All data are presented as the mean ± standard deviation. The Mann–Whitney test was used to compare the two groups, the percentage of the wear and corrosion of implants between patients with thoracolumbar fractures and patients with adjacent segment disease, as well as uniaxial pedicle screws and universal screws. Values at P < 0.05 were considered statistically significant.

All data generated and analyzed in this study are included in this published article.

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Department of Orthopedics, ZhongDa Hospital of Southeast University, Dingjiaqiao 87, Gulou District, Nanjing, China

Hangyu Ji, Xinhui Xie & Xiaotao Wu

School of Medicine, Southeast University, Nanjing, China

Hangyu Ji & Xiaotao Wu

The Department of Pathology, Xishan People’s Hospital, Wuxi, China

Zhe Jiang

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Hangyu Ji conducted experimental operation, data analysis and writed this article. Xinhui Xie analyzed and interpreted the patients data. Zhe Jiang was in charge of the HE staining experiment. Xiaotao Wu conducted experimental design and revision of manuscript. All authors read and approved the final manuscript.

Correspondence to Hangyu Ji or Xiaotao Wu.

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Ji, H., Xie, X., Jiang, Z. et al. Wear and corrosion of titanium alloy spinal implants in vivo. Sci Rep 14, 16847 (2024). https://doi.org/10.1038/s41598-024-68057-8

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Received: 20 January 2024

Accepted: 19 July 2024

Published: 22 July 2024

DOI: https://doi.org/10.1038/s41598-024-68057-8

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