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Bone & Joint Research
Vol. 13, Issue 11 | Pages 682 - 693
26 Nov 2024
Wahl P Heuberger R Pascucci A Imwinkelried T Fürstner M Icken N Schläppi M Pourzal R Gautier E

Aims. Highly cross-linked polyethylene (HXLPE) greatly reduces wear in total hip arthroplasty, compared to conventional polyethylene (CPE). Cross-linking is commonly achieved by irradiation. This study aimed to compare the degree of cross-linking and in vitro wear rates across a cohort of retrieved and unused polyethylene cups/liners from various brands. Methods. Polyethylene acetabular cups/liners were collected at one centre from 1 April 2021 to 30 April 2022. The trans-vinylene index (TVI) and oxidation index (OI) were determined by Fourier-transform infrared spectrometry. Wear was measured using a pin-on-disk test. Results. A total of 47 specimens from ten brands were included. The TVI was independent of time in vivo. A linear correlation (R. 2. = 0.995) was observed between the old and current TVI standards, except for vitamin E-containing polyethylene. The absorbed irradiation dose calculated from the TVI corresponded to product specifications for all but two products. For one electron beam-irradiated HXLPE, a mean dose of 241% (SD 18%) of specifications was determined. For another, gamma-irradiated HXLPE, a mean 41% (SD 13%) of specifications was determined. Lower wear was observed for higher TVI. Conclusion. The TVI is a reliable measure of the absorbed irradiation dose and does not alter over time in vivo. The products of various brands differ by manufacturing details and consequently cross-linking characteristics. Absorption and penetration of electron radiation and gamma radiation differ, potentially leading to higher degrees of cross-linking for electron radiation. There is a non-linear, inverse correlation between TVI and in vitro wear. The wear resistance of the HXLPE with low TVI was reduced and more comparable to CPE. Cite this article: Bone Joint Res 2024;13(11):682–693


Bone & Joint 360
Vol. 12, Issue 4 | Pages 44 - 46
1 Aug 2023
Burden EG Whitehouse MR Evans JT


Bone & Joint Research
Vol. 11, Issue 1 | Pages 23 - 25
17 Jan 2022
Matar HE Platt SR Bloch BV Board TN Porter ML Cameron HU James PJ


The Bone & Joint Journal
Vol. 102-B, Issue 11 | Pages 1527 - 1534
3 Nov 2020
Orita K Minoda Y Sugama R Ohta Y Ueyama H Takemura S Nakamura H

Aims

Vitamin E-infused highly cross-linked polyethylene (E1) has recently been introduced in total knee arthroplasty (TKA). An in vitro wear simulator study showed that E1 reduced polyethylene wear. However there is no published information regarding in vivo wear. Previous reports suggest that newly introduced materials which reduce in vitro polyethylene wear do not necessarily reduce in vivo polyethylene wear. To assist in the evaluation of the newly introduced material before widespread use, we established an in vivo polyethylene wear particle analysis for TKA. The aim of this study was to compare in vivo polyethylene wear particle generation between E1 and conventional polyethylene (ArCom) in TKA.

Methods

A total of 34 knees undergoing TKA (17 each with ArCom or E1) were investigated. Except for the polyethylene insert material, the prostheses used for both groups were identical. Synovial fluid was obtained at a mean of 3.4 years (SD 1.3) postoperatively. The in vivo polyethylene wear particles were isolated from the synovial fluid using a previously validated method and examined by scanning electron microscopy.


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1303 - 1310
3 Oct 2020
Kjærgaard K Ding M Jensen C Bragdon C Malchau H Andreasen CM Ovesen O Hofbauer C Overgaard S

Aims

The most frequent indication for revision surgery in total hip arthroplasty (THA) is aseptic loosening. Aseptic loosening is associated with polyethylene liner wear, and wear may be reduced by using vitamin E-doped liners. The primary objective of this study was to compare proximal femoral head penetration into the liner between a) two cross-linked polyethylene (XLPE) liners (vitamin E-doped (vE-PE)) versus standard XLPE liners, and b) two modular femoral head diameters (32 mm and 36 mm).

Methods

Patients scheduled for a THA were randomized to receive a vE-PE or XLPE liner with a 32 mm or 36 mm metal head (four intervention groups in a 2 × 2 factorial design). Head penetration and acetabular component migration were measured using radiostereometric analysis at baseline, three, 12, 24, and 60 months postoperatively. The Harris Hip Score, University of California, Los Angeles (UCLA) Activity Score, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey questionnaire (SF-36) were assessed at baseline, three, 12, 36, and 60 months.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 43 - 43
1 Feb 2017
Muratoglu O Bichara D O'Brien C Doshi B Oral E
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Introduction. We have previously demonstrated that peroxide crosslinked vitamin E-blended UHMWPE maintains its clinically-required wear and mechanical properties [1]. This material can potentially be used as an irradiation-free bearing surface for TJA. However, using organic peroxides in medical devices requires a thorough examination of tissues in contact with the implant. For this study we crosslinked polyethylene using five times the needed concentration of peroxide (2,5-Dimethyl-2,5-di(t-butylperoxy)-hexyne-3 or P130), followed by implantation to determine implant biocompatibility, and pre and post implant peroxide residual contents. Methods. The study was performed after institutional approval following ISO standard 10993–6. Study groups: not crosslinked (0.2 (1050) VE), crosslinked (0.2 VE (1050)/5% P130) and crosslinked-high temperature melted (HTM) (0.2 VE (1050)/5% P130). Materials were blended and consolidated, machined (2.5 diameter × 2.5 cm height), sterilized and implanted in the dorsum New Zealand white rabbits. Pre and post implantation FTIR was performed. Two samples were implanted in each rabbit; n=6 samples were included for each group. After 4 weeks, samples were explanted, analyzed using FTIR, and subcutaneous tissues processed for histological analysis. Results. FTIR absorbances at 914cm. −1. , 1169cm. −1. , and the OH absorbance at 3450cm. −1. showed differences between materials (Fig 1A). There was a significant increase in the absorbance at 914 for the non-crosslinked and crosslinked samples after explantation (p = 2.77E–17, p = 4.22E–23, Fig 1B). There was a significant decrease in all peroxide related absorbances after explantation for the crosslinked and HTM samples (p < 0.05, Fig 1B). Before implantation, these absorbances were significantly higher in the crosslinked and crosslinked/HTM samples than those in the non crosslinked sample (p<0.05, Fig 2A). Peroxide related absorbances of the crosslinked sample were also significantly higher than those of the crosslinked/HTM sample (p<0.05, Fig 2A). After explantation, the crosslinked samples had significantly higher absorbances than both the non crosslinked and crosslinked/HTM samples (p < 0.05, Fig 2A). All peroxide related absorbances of the crosslinked/HTM samples were significantly higher than those of the non crosslinked sample (p < 0.05, Fig 2A). The non crosslinked sample showed no significant differential between these absorbances at implantation and after retrieval. The crosslinked sample had the largest differential between the total peak absorbances before implantation and retrieval at 914cm. −1. The crosslinked/HTM samples had the largest differential between the total peak absorbances before and after implantation for both 1169cm. −1. and the OH absorbances (Fig 2B). All explants were recovered after four weeks in vivo (Fig 3A). No difference was found in the histological analysis of the tissue characterized by a synovial-like lining with signs of fibrosis around the implants (Fig 3B). Discussion. The main challenge of this study was identifying pre and postoperative implant peroxide residual peaks via FTIR. We wanted to ensure that peroxide was present in implants before implantation, to ensure their elution into tissues. Conclusions. Peroxide crosslinked polyethylene stabilized with vitamin E can potentially be used as an alternate bearing surface. Irradiation-free processing could result in cost-effectiveness and more accurate cross-linking of polyethylene implants


The Bone & Joint Journal
Vol. 97-B, Issue 11 | Pages 1463 - 1469
1 Nov 2015
Jonsson BA Kadar T Havelin LI Haugan K Espehaug B Indrekvam K Furnes O Hallan G

We report the five-year outcome of a randomised controlled trial which used radiostereometric analysis (RSA) to assess the influence of surface oxidised zirconium (OxZr, Oxinium) on polyethylene wear in vivo.

A total of 120 patients, 85 women and 35 men with a mean age of 70 years (59 to 80) who were scheduled for primary cemented total hip arthroplasty were randomly allocated to four study groups. Patients were blinded to their group assignment and received either a conventional polyethylene (CPE) or a highly cross-linked (HXL) acetabular component of identical design. On the femoral side patients received a 28 mm head made of either cobalt-chromium (CoCr) or OxZr.

The proximal head penetration (wear) was measured with repeated RSA examinations over five years. Clinical outcome was measured using the Harris hip score.

There was no difference in polyethylene wear between the two head materials when used with either of the two types of acetabular component (p = 0.3 to 0.6). When comparing the two types of polyethylene there was a significant difference in favour of HXLPE, regardless of the head material used (p < 0.001).

In conclusion, we found no advantage of OxZr over CoCr in terms of polyethylene wear after five years of follow-up. Our findings do not support laboratory results which have shown a reduced rate of wear with OxZr. They do however add to the evidence on the better resistance to wear of HXLPE over CPE.

Cite this article: Bone Joint J 2015;97-B:1463–9.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 160 - 160
1 Sep 2012
Kuzyk PR Saccone M Sprague S Simunovic N Bhandari M Schemitsch EH
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Purpose. Cross-linking of polyethylene greatly reduces its wear rate in hip simulator studies. We conducted a systematic review and meta-analysis of randomized controlled trials comparing cross-linked to conventional polyethylene liners for total hip arthroplasty to determine if there is a clinical reduction of: 1) wear rates, 2) radiographic osteolysis, and 3) need for total hip revision. Method. A systematic search of MEDLINE, EMBASE, and COCHRANE databases was conducted from inception to May 2010 for all trials involving the use of cross-linked polyethylene for total hip arthroplasty. Eligibility for inclusion in the review was: use of a random allocation of treatments; a treatment arm receiving cross-linked polyethylene and a treatment arm receiving conventional polyethylene for total hip arthroplasty; and use of radiographic wear as an outcome measure. Eligible studies were obtained and read in full by two co-authors who then independently applied the Checklist to Evaluate a Report of a Nonpharmacological Trial to each study. Pooled mean differences were calculated for the following continuous outcomes: bedding-in, linear wear rate, three dimensional linear wear rate, volumetric wear rate, and total linear wear. Pooled risk ratios were calculated for radiographic osteolysis and revision hip arthroplasty. Results. The literature search strategy identified 194 potential studies of which 12 met inclusion criteria. All studies reported a significant reduction in radiographic wear with cross-linked polyethylene. Pooled mean differences for linear wear rate, three dimensional linear wear rate, volumetric wear rate, and total linear wear were all significantly reduced for cross-linked polyethylene. The risk ratio for radiographic osteolysis was 0.40 (95% C.I. of 0.27 to 0.58; p<0.01; I2=0%), favoring cross-linked polyethylene. There were no significant differences in need for revision total hip arthroplasty or amount of bedding-in. Conclusion. Cross-linked polyethylene liners demonstrate reduced radiographic wear and osteolysis up to 8 years after implantation. Follow up is not long enough to show a difference in need for revision total hip arthroplasty. Cross-linked polyethylene should be considered for young patients undergoing total hip arthroplasty


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 204 - 204
1 Sep 2012
Zietz C Fritsche A Mittelmeier W Bader R
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The prevalent cause of implant failure after total joint replacement is aseptic loosening caused by wear debris. Improvement of the wear behaviour of the articulating bearing between the cup and femoral head is essential for increased survival rate of artificial hip joints. Cross-linking of the polyethylene (PE) material is one attempt to reduce wear particle release at the articulating surface. Various cross-linked polyethylenes (X-PE) are used in orthopaedics since several years. In total hip arthroplasty (THA) the use of larger femoral head sizes has specific reasons. Larger heads lead to a decreased risk of total hip dislocation and impingement as well as an improved range of motion in comparison to smaller head sizes like 28mm or less. However, the increasing diameter of femoral head can be associated with lower thickness of the PE liner and increased wear rate. Cross-linking of PE can improve the wear rate of the liner and hence supports the use of larger femoral heads. The aim of this experimental study was to evaluate the wear of standard vs. sequential X-PE (X3-PE) liner in combination with different ceramic femoral head sizes. Wear testing was performed for 5 million load cycles using standard UHMW-PE liners (N2Vac) and X3-PE liners (each Stryker GmbH & Co. KG, Duisburg, Germany) combined with 28mm ceramic ball heads and the Trident PSL acetabular cup (Stryker). Furthermore, X3-PE liners with an internal diameter of 36mm and 44mm and decreased wall thickness (5.9mm and 3.8mm) were combined with corresponding ceramic heads. An eight station hip wear simulator according to ISO 14242 (EndoLab GmbH, Rosenheim, Germany) was used to carry out the standard wear tests. The tests were realised in temperature-controlled chambers at 37°C containing calf serum (protein content 20g/l). The average gravimetrical wear rates of the standard UHMW-PE (N2Vac) liners combined with 28mm ceramic heads amounted to 12.6 ± 0.8mg/million cycles. Wear of X3-PE liners in combination with 28 mm ceramic heads was not detectable. The average gravimetrical wear rates of the X3-PE liners in combination with 36mm and 44mm ceramic heads amounted to 2.0 ± 0.5mg and 3.1 ± 0.3mg/million cycles, respectively. The purpose of this study was to evaluate the effect of femoral head size at THA on standard and sequential X-PE liner. The wear simulator tests showed that the wear rate of PE liners with small heads (28mm) decreased by cross-linking of the PE significantly. The amount of wear at X-PE increased slightly with larger head size (36mm and 44mm). However, by sequential cross-linking, the wear rate using thinner liners and larger femoral heads is reduced to a fractional amount of wear at conventional UHMW-PE. Hence, the above-mentioned advantages of larger femoral head diameters can be realised by improved wear behaviour of sequential X-PE


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 5 | Pages 593 - 600
1 May 2011
Kuzyk PRT Saccone M Sprague S Simunovic N Bhandari M Schemitsch EH

We conducted a systematic review and meta-analysis of randomised controlled trials comparing cross-linked with conventional polyethylene liners for total hip replacement in order to determine whether these liners reduce rates of wear, radiological evidence of osteolysis and the need for revision. The MEDLINE, EMBASE and COCHRANE databases were searched from their inception to May 2010 for all trials involving the use of cross-linked polyethylene in total hip replacement. Eligibility for inclusion in the review included the random allocation of treatments, the use of cross-linked and conventional polyethylene, and radiological wear as an outcome measure. The pooled mean differences were calculated for bedding-in, linear wear rate, three-dimensional linear wear rate, volumetric wear rate and total linear wear. Pooled risk ratios were calculated for radiological osteolysis and revision hip replacement. A search of the literature identified 194 potential studies, of which 12 met the inclusion criteria. All reported a significant reduction in radiological wear for cross-linked polyethylene.

The pooled mean differences for linear rate of wear, three-dimensional linear rate of wear, volumetric wear rate and total linear wear were all significantly reduced for cross-linked polyethylene. The risk ratio for radiological osteolysis was 0.40 (95% confidence interval 0.27 to 0.58; I2 = 0%), favouring cross-linked polyethylene. The follow-up was not long enough to show a difference in the need for revision surgery.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 281 - 281
1 Sep 2005
Grobbelaar C
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This study investigates the relationship between the quality of the arthroplasty and the radiological appearance of the interface. Of special interest is the prognostic value of sustained stability and of improvement in the interface, a phenomenon we have not previously seen. At 1 week and at 6 and 24 months postoperatively, we assessed radiographs of 20 randomly selected patients in whom cross-linked polyethylene cups had been implanted. We classified them into three stages: in stage 0 there was no interface in any zone, in stage I less than 2 mm and in stage II more than 2 mm. This was not a comparative study, but an important feature was the sustainment and/or improvement of the interface. In 16 patients a complete ‘white-out’ of interfaces in postoperative x-rays was sustained for the duration of the study. In three patients imperfect postoperative interfaces clearly improved. In only one patient, who had developed infection, was there deterioration. Widening was seen only in cases of gross mechanical failure or sepsis. We postulate that cross-linking of polyethylene results in virtual absence of HDP debris and that this is the main reason for interface improvement. It is polythene particles that cause osteolysis, and their elimination dramatically improves the prognosis for total joint replacement. The results reconfirm that, provided fixation is complete, cement is not the main reason for interface failure. We believe that this method makes total joint replacement viable even in young patients


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 352 - 352
1 Sep 2005
Weber F Grobbelaar C du Plessis T Cakic J
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Introduction and Aims: Wear of ultra-high molecular weight polyethylene (UHMWPE) acetabular cups is a well-known cause of osteolysis and loosening of the components. Improvement of the wear resistance of UHMWPE could extend the clinical life of total hip arthroplasty (THA). Chemical cross-linking in acetylene with gamma radiation is a cheap and effective way of increasing wear resistance of UHMWPE.

Method: This study is a report on 132 patients operated between 1977 and 1984, using the Pretoria monobloc stainless steel hip with 30mm metal head. Acetabular cups were machined from RAM extruded rectangular bars (RCH 1000). Final cups were gamma irradiated in stainless steel containers filled with acetylene gas. Three hundred microns surface cross-linking was achieved at 100kG. At that time, 1059 hip replacements were performed by the two first authors. The retrospective study consisted of measurement of the radiological wear. The criteria was to compare and measure the wear from early post-op radiograph and longest follow-up radiograph. Linear wear was measured according to the Livermore methods. Exclusion criteria included follow-up less than 10 years, sepsis, dislocation and other non wear-related causes of failure. The rarely retrieved cross-linked ace-tabular cups were analysed individually using spectrum electron microsope (SEM).

Conclusion: The South African contribution to the method of cross-linking is important. This is a cheap and effective way to improve the quality of the polyethylene. Results of this long-term group of patients with cross-linked UHMWPE show a significant decrease in the wear rate, significantly increasing the longevity of the THR.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_IV | Pages 438 - 438
1 Apr 2004
Asano T
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Wear of ultra-high molecular weight polyethylene (UHMWPE) is a major factor that affects longevity of the total joint replacement. In total hips, cross-linking of polyethylene acetabular cup has been shown highly effective in reducing wear both clinically and experimentally. In TKR, Schmidig 2000 showed 90% reduction of wear rate in 10 Mrad irradiated tibial inserts compared to 3 Mrad irradiated tibial inserts. Thus crosslinking should provide substantial improvement also in the wear resistance of UHMWPE tibial inserts. Our objective was to compare 3 Mrad UHMWPE with 10 Mrad HCLPE in same design but comparing standard kinematics to more severe mal-rotation kinematics. The latter offsets the tibial tray with 15 degrees internal rotation such the central tibial eminencies became involved in the wear process. Our hypothesis was that HCLPE would be more resistant than the standard UHMPE even in the mal-rotation model. The control material was Duracon 3 Mrad UHMWPE. HCLPE was radiation crosslinked to 10 Mrad mater


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_I | Pages 79 - 79
1 Mar 2002
Weber F Grobbelaar C du Plessis T Cakic J Spirakis A Cappaert G
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Wear of ultra-high molecular weight polyethylene (UHMWP) acetabular cups is a well-known cause of osteolysis and loosening of the components. Improvement of the wear resistance of UHMWP could extend the clinical life of total hip arthroplasty (THA). Chemical cross-linking in acetylene with gamma radiation is a cheap and effective way of increasing wear resistance of UHMWP.

This study is a report on 263 patients (123 males and 140 females) on whom Dr Weber performed THA between 1977 and 1984, using the Pretoria (Grobbelaar) monobloc stainless steel hip with 30-mm metal head. There were 96 patients (107 prostheses) available for follow-up at a mean of 18.3 years, with 89 surviving prosthesis in 79 patients (83.2%).

We collected complete sets of radiographs of 54 patients (mean age 71.4 years) for a radiological survey in 1999. In 41 patients (76%) we found no wear. The mean age of these patients was 72 years. Wear was noted in the other 13 patients (24%), whose mean age was 75 years. The mean follow-up time was 16 years (8 to 23). The mean magnification in the radiological study was 18%. Mean wear for the total group was 1.29 mm and mean annual wear 0.17 mm.

A similar analysis performed on a group of 64 of Dr Grobbelaar’s patients at 15.5 year mean follow-up shows remarkable similarity, with mean wear of 0.172 mm for a group of 64 patients and annual wear 0.11 mm. Dr Oonishi of Japan, who has conducted the only other long-term follow-up, found similarly promising results.