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Evaluation and Prospects of the Wear Performance of Highly Crosslinked Polyethylene Acetabular Liners Containing Vitamin E

China NMPA 2025-03-04 10:32:36

Total hip arthroplasty (THA) is one of the most successful orthopedic surgeries, bringing immeasurable benefits to patients with hip diseases around the world[1]. However, the biggest obstacle for patients with hip diseases on the road to recovery is postoperative complications, among which aseptic loosening is one of the main reasons leading to revision surgery. Early studies found that the wear rate of traditional ultra-high molecular weight polyethylene liners would directly lead to aseptic loosening of the prosthesis, thus advancing the time for revision surgery[2]. To overcome the shortcomings of ultra-high molecular weight polyethylene, scientists discovered highly cross-linked polyethylene (HXLPE) at the end of the 1990s[3], but new problems arose: the manufacturing process of HXLPE liners during sterilization and irradiation produces free radicals[4]. Free radicals can damage the internal polymer structure of the liner and accelerate oxidation. As research progressed, it was found that vitamin E is a good antioxidant that can block the oxidative chain reaction of free radicals, specifically improving the processing drawbacks of HXLPE[5-6].

Total hip arthroplasty (THA) is one of the most successful orthopedic surgeries, bringing immeasurable benefits to patients with hip diseases around the world[1][1]. However, the biggest obstacle for patients with hip diseases on the road to recovery is postoperative complications, among which aseptic loosening is one of the main reasons leading to revision surgery. Early studies found that the wear rate of traditional ultra-high molecular weight polyethylene liners would directly lead to aseptic loosening of the prosthesis, thus advancing the time for revision surgery[2][2]. To overcome the shortcomings of ultra-high molecular weight polyethylene, scientists discovered highly cross-linked polyethylene (HXLPE) at the end of the 1990s[3][3], but new problems arose: the manufacturing process of HXLPE liners during sterilization and irradiation produces free radicals[4][4]. Free radicals can damage the internal polymer structure of the liner and accelerate oxidation. As research progressed, it was found that vitamin E is a good antioxidant that can block the oxidative chain reaction of free radicals, specifically improving the processing drawbacks of HXLPE[5-6][5-6].
E. Oral, S's in vitro study showed that infusing vitamin E into HXLPE not only reduces the wear rate but also eliminates free radicals generated by irradiation[7]. The report content is summarized as follows: two groups of test samples (vitamin E-infused highly cross-linked ultra-high molecular weight polyethylene and traditional ultra-high molecular weight polyethylene) were subjected to wear performance studies after gamma-ray irradiation sterilization. After five million cycles simulating gait, the average wear rate of the 28 mm traditional ultra-high molecular weight polyethylene acetabular cup was 9.54±0.73 mg/Mc (adjusted for fluid absorption), while the average wear rates of the 28 mm and 36 mm vitamin E-infused highly cross-linked ultra-high molecular weight polyethylene acetabular cups were 0.78±0.28 and 0.97±0.49 mg/Mc, respectively, which is a 10-fold reduction compared to the traditional ultra-high molecular weight polyethylene acetabular cup.
E. Oral, S's in vitro study showed that infusing vitamin E into HXLPE not only reduces the wear rate but also eliminates free radicals generated by irradiation[7][7]The research report content is summarized as follows: two sets of test samples (highly cross-linked ultra-high molecular weight polyethylene containing vitamin E and conventional ultra-high molecular weight polyethylene) were subjected to wear performance studies after gamma-ray irradiation sterilization. After five million cycles of simulated gait, the average wear rate of 28 mm conventional ultra-high molecular weight polyethylene acetabular liners was 9.54±0.73 mg/Mc (after fluid absorption calibration), while for 28 mm and 36 mm highly cross-linked ultra-high molecular weight polyethylene acetabular liners containing vitamin E, the average wear rates were 0.78±0.28 and 0.97±0.49 mg/Mc, respectively, a reduction by a factor of 10 compared to conventional ultra-high molecular weight polyethylene acetabular liners.
Compared with laboratory data, the actual performance of highly cross-linked ultra-high molecular weight polyethylene acetabular liners containing vitamin E in clinical use is not so pronounced. Joost H J van Erp compiled the results of a two-year clinical trial for both materials' acetabular components[8]. This randomized controlled trial included 199 patients, with 102 patients receiving the highly cross-linked ultra-high molecular weight polyethylene acetabular liner containing vitamin E, and 97 patients receiving the conventional ultra-high molecular weight polyethylene acetabular liner. The observation points were preoperative, 3 months postoperative, 12 months postoperative, and 24 months postoperative, using the mean linear head penetration rate (FHP) to compare wear rates through the collection of clinical and radiological parameters. Of these 199 patients, 188 (94%) completed a 2-year follow-up. The FHP for the group with the highly cross-linked ultra-high molecular weight polyethylene liner containing vitamin E was 0.046 mm/year, whereas for the control group with the conventional ultra-high molecular weight polyethylene liner, it was 0.056 mm/year. The researcher then continued the follow-up observations, obtaining 6-year clinical trial follow-up data[9]. The data showed that 173 patients (87%) completed a 6-year follow-up. For the group with the highly cross-linked ultra-high molecular weight polyethylene liner containing vitamin E, the FHP was 0.028 mm/year, and for the control group with the conventional ultra-high molecular weight polyethylene liner, it was 0.035 mm/year. During the follow-up period, no adverse reactions related to the clinical application of highly cross-linked ultra-high molecular weight polyethylene containing vitamin E occurred, and the 6-year revision survival rate for both acetabular liners was 98%, with no cases of aseptic loosening. Goulven Rochcongar's 5-year follow-up data also showed similar results[10]. Five years postoperatively, the FHP for the group with the highly cross-linked ultra-high molecular weight polyethylene liner containing vitamin E was 0.02 mm/year, and for the conventional ultra-high molecular weight polyethylene liner group, it was 0.06 mm/year. Both studies demonstrated the clinical performance of highly cross-linked ultra-high molecular weight polyethylene containing vitamin E, showing a certain degree of reduction in wear in terms of FHP compared to conventional ultra-high molecular weight polyethylene liners.
Compared with laboratory data, the actual performance of highly cross-linked ultra-high molecular weight polyethylene acetabular liners containing vitamin E in clinical use is not so pronounced. Joost H J van Erp compiled the results of a two-year clinical trial for both materials' acetabular components[8][8]. This randomized controlled trial included a total of 199 patients, with 102 patients in the vitamin E-infused highly cross-linked ultra-high molecular weight polyethylene (UHMWPE) acetabular liner group and 97 patients in the conventional UHMWPE acetabular liner group. The observation points were pre-operation, 3 months, 12 months, and 24 months post-operation, where clinical and radiological parameters were collected to compare wear rates using the mean linear femoral head penetration (FHP). Among these 199 patients, 188 patients (94%) completed the 2-year follow-up. The FHP for the vitamin E-infused highly cross-linked UHMWPE liner group was 0.046 mm/year, while the FHP for the control group, which used conventional UHMWPE liners, was 0.056 mm/year. The researchers then continued their follow-up observations, obtaining 6-year clinical trial follow-up data[9][9]. The data showed that 173 patients (87%) completed the 6-year follow-up. For the vitamin E-infused highly cross-linked UHMWPE liner group, the FHP was 0.028 mm/year, and for the conventional UHMWPE liner group, it was 0.035 mm/year. During the follow-up period, there were no adverse reactions related to the clinical application of vitamin E-infused highly cross-linked UHMWPE, and the 6-year revision survival rate for both types of acetabular liners was 98%, with no cases of aseptic loosening. Goulven Rochcongar's 5-year follow-up data also showed similar results[10][10]. Five years after surgery, the FHP for the vitamin E-infused highly cross-linked UHMWPE liner group was 0.02 mm/year, while for the conventional UHMWPE liner group, it was 0.06 mm/year. These two studies both demonstrated that, compared to conventional UHMWPE liners, the vitamin E-infused highly cross-linked UHMWPE group had a certain degree of reduction in wear as measured by FHP.
The above clinical data are all comparisons of wear between vitamin E-infused highly cross-linked UHMWPE and conventional UHMWPE. Compared to conventional UHMWPE materials, highly cross-linked UHMWPE is also favored by doctors due to its lower wear rate. Bergvinsson H's research data compared the clinical wear performance of these two types of highly cross-linked polyethylenes[11].
The above clinical data are all comparisons of wear between vitamin E-infused highly cross-linked UHMWPE and conventional UHMWPE. Compared to conventional UHMWPE materials, highly cross-linked UHMWPE is also favored by doctors due to its lower wear rate. Bergvinsson H's research data compared the clinical wear performance of these two types of highly cross-linked polyethylenes[11][11].

The study included a total of 94 patients, with 43 patients in the highly crosslinked ultra-high molecular weight polyethylene group and 51 patients in the vitamin E-containing highly crosslinked ultra-high molecular weight polyethylene group. Analysis software was used to analyze X-rays taken immediately after surgery, one year post-surgery, and five years post-surgery. The results showed no significant difference in wear rates between the two materials (highly crosslinked ultra-high molecular weight polyethylene: 23.2 μm/year, vitamin E-containing highly crosslinked ultra-high molecular weight polyethylene: 24.0 μm/year, p = 0.73). Due to the very small difference in wear rates, it is difficult to predict whether clinical differences will be found in future follow-ups; therefore, longer-term follow-up is needed to continue assessing the clinical differences between vitamin E-containing highly crosslinked ultra-high molecular weight polyethylene acetabular liners and highly crosslinked ultra-high molecular weight polyethylene.


References:

[1] J. Katz, K. Arant, and R. J. J. Loeser, “Diagnosis and treatment of hip and knee osteoarthritis: a review,” JAMA, vol. 325, no. 6, pp. 568–578, 2021.

[2] A. Forster, Z. Tsinas, and M. J. P. Al-Sheikhly, “Effect of irradiation and detection of long-lived polyenyl radicals in highly crystalline ultra-high molar mass polyethylene (UHMMPE) fibers,” Polymers, vol. 11, no. 5, p. 924, 2019.

[2] A. Forster, Z. Tsinas, and M. J. P. Al-Sheikhly, “Effect of irradiation and detection of long-lived polyenyl radicals in highly crystalline ultra-high molar mass polyethylene (UHMMPE) fibers,” Polymers, vol. 11, no. 5, p. 924, 2019.

[3] S. Kurtz, H. Gawel, and J. D. Patel, “History and systematic review of wear and osteolysis outcomes for first-generation highly crosslinked polyethylene,” Clinical Orthopaedics and Related Research, vol. 469, no. 8, pp. 2262–2277, 2011.

[3] S. Kurtz, H. Gawel, and J. D. Patel, “History and systematic review of wear and osteolysis outcomes for first-generation highly crosslinked polyethylene,” Clinical Orthopaedics and Related Research, vol. 469, no. 8, pp. 2262–2277, 2011.

[4] E. Oral and O. K. Muratoglu, “Vitamin E diffused, highly crosslinked UHMWPE: a review,” International Orthopaedics, vol. 35, no. 2, pp. 215–223, 2011.

[4] E. Oral and O. K. Muratoglu, “Vitamin E diffused, highly crosslinked UHMWPE: a review,” International Orthopaedics, vol. 35, no. 2, pp. 215–223, 2011.

[5] B. Currier, J. Currier, M. Mayor, K. Lyford, J. Collier, and D. W. van Citters, “Evaluation of oxidation and fatigue damage of retrieved crossfire polyethylene acetabular cups,” The Journal of Bone & Joint Surgery, vol. 89, no. 9, pp. 2023–2029, 2007.

[5] B. Currier, J. Currier, M. Mayor, K. Lyford, J. Collier, and D. W. van Citters, “Evaluation of oxidation and fatigue damage of retrieved crossfire polyethylene acetabular cups,” The Journal of Bone & Joint Surgery, vol. 89, no. 9, pp. 2023–2029, 2007.

[6] E. Oral, K. Wannomae, S. Rowell, and O. J. B. Muratoglu, “Diffusion of vitamin E in ultra-high molecular weight polyethylene,” Biomaterials, vol. 28, no. 35, pp. 5225–5237, 2007.

[6] E. Oral, K. Wannomae, S. Rowell, and O. J. B. Muratoglu, “Diffusion of vitamin E in ultra-high molecular weight polyethylene,” Biomaterials, vol. 28, no. 35, pp. 5225–5237, 2007.

[7] E. Oral, S. Christensen, A. Malhi, K. Wannomae, and O. K. Muratoglu, “Wear Resistance and Mechanical Properties of Highly Cross-linked, Ultrahigh- Molecular Weight Polyethylene Doped With Vitamin E,” The Journal of Arthroplasty, vol. 21, no. 4, pp. 580–591, 2006.

[7] E. Oral, S. Christensen, A. Malhi, K. Wannomae, and O. K. Muratoglu, “Wear Resistance and Mechanical Properties of Highly Cross-linked, Ultrahigh- Molecular Weight Polyethylene Doped With Vitamin E,” The Journal of Arthroplasty, vol. 21, no. 4, pp. 580–591, 2006.

[8] Joost H J van Erp, Julie R A Massier, Jelle J Halma, Thom E Snijders & Arthur de Gast (2020) 2-year results of an RCT of 2 uncemented isoelastic monoblock acetabular components: lower wear rate with vitamin E blended highly cross-linked polyethylene compared to ultra-high molecular weight polyethylene, Acta Orthopaedica, 91:3, 254-259, DOI: 10.1080/17453674.2020.1730073

[8] Joost H J van Erp, Julie R A Massier, Jelle J Halma, Thom E Snijders & Arthur de Gast (2020) 2-year results of an RCT of 2 uncemented isoelastic monoblock acetabular components: lower wear rate with vitamin E blended highly cross-linked polyethylene compared to ultra-high molecular weight polyethylene, Acta Orthopaedica, 91:3, 254-259, DOI: 10.1080/17453674.2020.1730073

[9] Julie R A Massier, Joost H J Van Erp, Thom E Snijders & Arthur DE Gast (2020) A vitamin E blended highly cross-linked polyethylene acetabular cup results in less wear: 6-year results of a randomized controlled trial in 199 patients, Acta Orthopaedica, 91:6, 705-710, DOI: 10.1080/17453674.2020.1807220

[9] Julie R A Massier, Joost H J Van Erp, Thom E Snijders & Arthur DE Gast (2020) A vitamin E blended highly cross-linked polyethylene acetabular cup results in less wear: 6-year results of a randomized controlled trial in 199 patients, Acta Orthopaedica, 91:6, 705-710, DOI: 10.1080/17453674.2020.1807220

[10] Goulven Rochcongar, Matthieu Remazeilles, Emeline Bourroux, Julien Dunet, Valentin Chapus, Matthieu Feron, César Praz, Geoffrey Buia & Christophe Hulet (2021) Reduced wear in vitamin E-infused highly cross-linked polyethylene cups: 5-year results of a randomized controlled trial, Acta Orthopaedica, 92:2, 151-155, DOI: 10.1080/17453674.2020.1852785

It appears that the provided text is already in English, so no translation was needed for the content. The HTML tags and URLs have been kept as they were. If you intended to provide a different piece of text for translation or if there's anything else I can assist with, please let me know![10] Goulven Rochcongar, Matthieu Remazeilles, Emeline Bourroux, Julien Dunet, Valentin Chapus, Matthieu Feron, César Praz, Geoffrey Buia & Christophe Hulet (2021) Reduced wear in vitamin E-infused highly cross-linked polyethylene cups: 5-year results of a randomized controlled trial, Acta Orthopaedica, 92:2, 151-155, DOI: 10.1080/17453674.2020.1852785

[11] Bergvinsson H, Zampelis V, Sundberg M, Tjörnstrand J, Flivik G. Vitamin E infused highly cross-linked cemented cups in total hip arthroplasty show good wear pattern and stabilize satisfactorily: a randomized, controlled RSA trial with 5-year follow-up. Acta Orthop. 2022 Jan 20;93:249-255. doi: 10.2340/17453674.2022.1517. PMID: 35048993; PMCID: PMC8788680.

[11] Bergvinsson H, Zampelis V, Sundberg M, Tjörnstrand J, Flivik G. Vitamin E infused highly cross-linked cemented cups in total hip arthroplasty show good wear pattern and stabilize satisfactorily: a randomized, controlled RSA trial with 5-year follow-up. Acta Orthop. 2022 Jan 20;93:249-255. doi: 10.2340/17453674.2022.1517. PMID: 35048993; PMCID: PMC8788680.

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