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      Decreased stress shielding with poly-ether-ether-ketone tibial implant for total knee arthroplasty - A preliminary study using finite element analysis

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          Abstract

          In total knee arthroplasty (TKA), the mechanical mismatch between cobalt-chromium (CoCr) alloy tibial implant and bone has been implicated in stress shielding and subsequent implant failure and bone resorption. This study investigates the biomechanical advantages of poly-ether-ether-ketone (PEEK) tibial implant, which exhibit properties analogous to those of the surrounding bone. A finite element analysis (FEA) was employed to assess and compare the biomechanical performances of PEEK and CoCr tibial implants in patients with and without osteoporosis. Four FEA models were constructed with PEEK and CoCr alloy implants in normal and osteoporotic tibias. Based on previous literature and our clinical experience, stresses measurements were taken at 16 points on the tibial plateau and 8 points on the two surfaces which were 10 mm and 20 mm apart from the tibial plateau, with specific regions quantified for stress shielding. The results showed significant differences in stress distribution between PEEK and CoCr implants. The PEEK implants exhibited higher equivalent stresses on the tibial plateau in all models (normal bone: 0.22 ± 0.07 MPa vs. 0.13 ± 0.06 MPa, p < 0.01; osteoporotic bone: 0.39 ± 0.06 MPa vs. 0.17 ± 0.07 MPa, p < 0.01). In non-osteoporotic models, the mean equivalent stresses on proximal tibial surfaces were similarly elevated for PEEK implants (0.29 ± 0.13 MPa vs. 0.21 ± 0.08 MPa, p = 0.02). The CoCr implants demonstrated more stress shielding across all measured regions (tibial plateau: 23.47% vs. 2.73%; surface 1: 15.93% vs. 1.37%; surface 2: 10.71% vs. 6.56%). These disparities were even more pronounced in osteoporotic models in the CoCr group (tibial plateau: 32.50% vs. 8.36%). The maximum equivalent stresses on the tibial plateau further supported this trend (normal bone: 1.02 MPa vs. 0.52 MPa; osteoporotic bone: 1.43 MPa vs. 0.67 MPa). These data confirm the hypothesis that a PEEK tibial implant can reduce peri-prosthetic stress shielding, suggesting that PEEK implants have the capability to distribute loads more uniformly and maintain a closer approximation to physiological conditions.

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          Most cited references28

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          How long does a knee replacement last? A systematic review and meta-analysis of case series and national registry reports with more than 15 years of follow-up

          Summary Background Knee replacements are the mainstay of treatment for end-stage osteoarthritis and are effective. Given time, all knee replacements will fail and knowing when this failure might happen is important. We aimed to establish how long a knee replacement lasts. Methods In this systematic review and meta-analysis, we searched MEDLINE and Embase for case series and cohort studies published from database inception until July 21, 2018. Articles reporting 15 year or greater survival of primary total knee replacement (TKR), unicondylar knee replacement (UKR), and patellofemoral replacements in patients with osteoarthritis were included. Articles that reviewed specifically complex primary surgeries or revisions were excluded. Survival and implant data were extracted, with all-cause survival of the knee replacement construct being the primary outcome. We also reviewed national joint replacement registry reports and extracted the data to be analysed separately. In the meta-analysis, we weighted each series and calculated a pooled survival estimate for each data source at 15 years, 20 years, and 25 years, using a fixed-effects model. This study is registered with PROSPERO, number CRD42018105188. Findings From 4363 references found by our initial search, we identified 33 case series in 30 eligible articles, which reported all-cause survival for 6490 TKRs (26 case series) and 742 UKRs (seven case series). No case series reporting on patellofemoral replacements met our inclusion criteria, and no case series reported 25 year survival for TKR. The estimated 25 year survival for UKR (based on one case series) was 72·0% (95% CI 58·0–95·0). Registries contributed 299 291 TKRs (47 series) and 7714 UKRs (five series). The pooled registry 25 year survival of TKRs (14 registries) was 82·3% (95% CI 81·3–83·2) and of UKRs (four registries) was 69·8% (67·6–72·1). Interpretation Our pooled registry data, which we believe to be more accurate than the case series data, shows that approximately 82% of TKRs last 25 years and 70% of UKRs last 25 years. These findings will be of use to patients and health-care providers; further information is required to predict exactly how long specific knee replacements will last. Funding The National Joint Registry for England, Wales, Northern Ireland, and Isle of Man and the Royal College of Surgeons of England.
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            Robotic-assisted TKA reduces postoperative alignment outliers and improves gap balance compared to conventional TKA.

            Several studies have shown mechanical alignment influences the outcome of TKA. Robotic systems have been developed to improve the precision and accuracy of achieving component position and mechanical alignment.
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              The in vitro response of human osteoblasts to polyetheretherketone (PEEK) substrates compared to commercially pure titanium.

              Polyetheretherketone (PEEK) is used as an alternative to titanium in medical devices. Previous in vitro studies examining PEEK have differed in their choice of polymer variant [PEEK or carbon-fiber reinforced PEEK (CFR-PEEK)], source of polymer (some of which are no longer available or for implantation) and cell type. While all studies demonstrated favorable cytocompatibility of the PEEK material, no studies are available which reflect the current state of the art of the material. Here, we use different forms of the only implantable grade PEEK available. These are compared with commercially pure titanium (cpTi) Grade 1 using a human primary osteoblast model. Sample materials were presented as industrially relevant surfaces. Machined or injection molded PEEK and CFR-PEEK were evaluated along with polished (Ra=0.200microm) and rough (Ra=0.554microm) cpTi. Osteoblast adhesion at 4h on injection molded variants of PEEK (Ra=0.095microm) and CFR-PEEK (Ra=0.350microm) material was comparable to titanium. Machined variants of PEEK (Ra=0.902microm) and CFR-PEEK (Ra=1.106microm) materials were significantly less. Proliferation at 48h determined by [(3)H]-thymidine incorporation was the greatest on the smoothest of all materials, the injection molded unfilled PEEK, which was significantly higher than the rough titanium control. The machined unfilled PEEK had the lowest DNA synthesis. RT-PCR for alkaline phosphatase, Type I collagen and osteocalcin normalized to glyceraldehyde-3-phosphate dehydrogenase revealed different patterns of mRNA levels. High mRNA levels for Type I collagen showed that CFR-PEEK stimulated osteoblast differentiation, whilst injection molded unfilled PEEK was less differentiated. Machined unfilled PEEK had comparable message levels of bone matrix proteins as rough titanium. All material variants permitted a degree of mineralization. Scanning electron microscopy at 3 days and 2 weeks in differentiation medium showed that human osteoblasts were well spread on all the different substrates. The varied response reported here at different time points during the study suggests that material formulation (unfilled PEEK or CFR-PEEK), subjection to industrial processing, surface roughness and topography may all influence the cellular response of osteoblasts to PEEK. Thus, differences in human osteoblast responses were found to the various samples of PEEK, but implantable grade PEEK, in general, was comparable in vitro to the bone forming capacity of rough titanium.
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                Author and article information

                Contributors
                Journal
                Heliyon
                Heliyon
                Heliyon
                Elsevier
                2405-8440
                29 February 2024
                15 March 2024
                29 February 2024
                : 10
                : 5
                : e27204
                Affiliations
                [a ]Department of Joint Surgery, Honghui Hospital, Xi’An Jiaotong University, No.555 East Youyi Road, Xi'an, Shaanxi, China
                [b ]Department of Architecture, Xi’An University of Architecture and Technology, No.13 Yanta Road, Xi'an, Shaanxi, China
                Author notes
                [* ]Corresponding author. 280771976@ 123456qq.com
                Article
                S2405-8440(24)03235-3 e27204
                10.1016/j.heliyon.2024.e27204
                10920710
                38463834
                e092f733-e58e-4bed-810c-012e4e0374b0
                © 2024 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 7 October 2023
                : 26 February 2024
                : 26 February 2024
                Categories
                Research Article

                stress shielding,peek,cocr alloy,tibia implant,total knee arthroplasty

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