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      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

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          Abstract

          Background and purpose

          Vitamin E infused highly cross-linked polyethylene (VEPE) was introduced in order to enhance oxidative resistance in highly cross-linked polyethylene cups in total hip arthroplasty (THA). We have, with a follow-up of 5 years, evaluated wear characteristics of 2 identically designed cemented cups with the only difference being the material, VEPE or ultra-high molecular weight polyethylene (UHMWPE). Furthermore, we report cup migration and clinical outcome.

          Patients and methods

          48 patients with primary osteoarthritis were randomized to either UHMWPE or VEPE cups. Patients were followed with radiostereometric analysis (RSA) from the first postoperative day, at 3 months, 1, 2, and 5 years as well as with hip-specific outcome questionnaires.

          Results

          At 3 months the mean proximal head penetration for UHMWPE was 0.07 mm (95% CI 0.03–0.11) and for VEPE 0.06 mm (–0.01 to 0.13). Thereafter, there was a continuous annual wear of 0.08 mm/year, up to 0.46 mm (0.36–0.57) at 5 years, for the UHMWPE cup. The VEPE cup showed low annual wear of 0.01 mm/year, up to 0.09 mm (0.02–0.16) at 5 years. In the first 3 months the UHMWPE cup migrated cranially 0.08 mm (0.03–0.13) whereas the VEPE cup migrated 0.17 mm (0.10–0.24), Thereafter, they showed similar migration patterns with stabilization between 2 and 5 years up to 0.21 mm (0.04–0.39) and 0.24 mm (0.13–0.36) respectively. The HOOS remained good up to 5 years, and no cup was revised.

          Interpretation

          Compared with otherwise identical UHMWPE cups the cemented VEPE cup shows statistically significant reduction of wear up to 5 years and both cup types stabilize well with good clinical outcome.

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          Most cited references19

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          Guidelines for standardization of radiostereometry (RSA) of implants.

          There is a need for standardization of radiostereometric (RSA) investigations to facilitate comparison of outcome reported from different research groups. In this document, 6 research centers have agreed upon standards for terminology, description and use of RSA arrangement including radiographic set-up and techniques. Consensus regarding minimum requirements for marker stability and scatter, choice of coordinate systems, and preferred way of describing prosthetic micromotion is of special interest. Some notes on data interpretation are also presented. Validation of RSA should be standardized by preparation of protocols for assessment of accuracy and precision. Practical issues related to loading of the joint by weight bearing or other conditions, follow-up intervals, length of follow-up, radiation dose, and the exclusion of patients due to technical errors are considered. Finally, we present a checklist of standardized output that should be included in any clinical RSA paper.This document will form the basis of a detailed standardization protocol under supervision of ISO and the European Standards Working Group on Joint Replacement Implants (CEN/TC 285/WG4). This protocol will facilitate inclusion of RSA in a standard protocol for implant testing before it is released for general use. Such a protocol-also including other recognized clinical outcome parameters-will reduce the risk of implanting potentially inferior prostheses on a large scale.
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            A literature review of the association between wear rate and osteolysis in total hip arthroplasty.

            The establishment of a polyethylene wear rate threshold for the development of osteolysis at the hip would allow surgeons to identify patients at risk for osteolysis and to implement selective, more frequent follow-up. We reviewed publications that met certain criteria for wear and osteolysis measurement. Based on this review, the incidence of osteolysis increases as the rate of wear increases. The literature indicates that osteolysis rarely is observed at a wear rate of <0.1 mm/y. We suggest that a practical wear rate threshold of 0.05 mm/y would eliminate osteolysis. This wear threshold suggests that the new cross-linked polyethylenes would reduce osteolysis, provided that in vivo wear rates mirror those observed in vitro. To facilitate future comparison of published data, we suggest that longitudinal wear studies adopt consistent edge detection-based wear measurement techniques and uniform osteolytic lesion classification and measurement schema. Copyright 2002, Elsevier Science (USA). All rights reserved.
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              History and systematic review of wear and osteolysis outcomes for first-generation highly crosslinked polyethylene.

              Highly crosslinked polyethylene (HXLPE) was introduced to reduce wear and osteolysis in total joint arthroplasty. While many studies report wear and osteolysis associated with HXLPE, analytical techniques, clinical study design and followup, HXLPE formulation and implant design characteristics, and patient populations differ substantially among investigations, complicating a unified perspective. Literature on first-generation HXLPE was summarized. We systematically reviewed the radiographic wear data and incidence of osteolysis for HXLPE in hip and knee arthroplasty. PubMed identified 391 studies; 28 met inclusion criteria for a weighted-averages analysis of two-dimensional femoral head penetration rates. To determine the incidence of osteolysis, we estimated a pooled odds ratio using a random-effects model. Weighted-averages analyses of femoral head penetration rates in HXLPE liners and conventional UHMWPE liners resulted, respectively, in a mean two-dimensional linear penetration rate of 0.042 mm/year based on 28 studies (n=1503 hips) and 0.137 mm/year based on 18 studies (n=695 hips). The pooled odds ratio for the risk of osteolysis in HXLPE versus conventional liners was 0.13 (95% confidence interval, 0.06-0.27) among studies with minimum 5-year followup. We identified two clinical studies of HXLPE in TKA, preventing systematic analysis of outcomes. HXLPE liner studies consistently report lower femoral head penetration and an 87% lower risk of osteolysis. Reduction in femoral head penetration or osteolysis risk is not established for large-diameter (>32 mm) metallic femoral heads or ceramic femoral heads of any size. Few studies document the clinical performance of HXLPE in knees.
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                Author and article information

                Journal
                Acta Orthop
                Acta Orthop
                ActaO
                Acta Orthopaedica
                Medical Journals Sweden, on behalf of the Nordic Orthopedic Federation
                1745-3674
                1745-3682
                20 January 2022
                2022
                : 93
                : 249-255
                Affiliations
                Department of Orthopedics, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden
                Author notes
                Article
                ActaO-93-1517
                10.2340/17453674.2022.1517
                8788680
                35048993
                d118ada7-4420-47f0-8b9e-94c5df0e4001
                © 2022 The Author(s)

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( https://creativecommons.org/licenses/by-nc/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material for non-commercial purposes, provided proper attribution to the original work.

                History
                : 25 October 2021
                : 23 December 2021
                Categories
                Article

                Orthopedics
                Orthopedics

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