A randomized double-blind noninferiority trial, evaluating migration of a cemented vitamin E-stabilized highly crosslinked component compared with a standard polyethylene component in reverse hybrid total hip arthroplasty

Aims Radiostereometric analysis (RSA) studies of vitamin E-doped, highly crosslinked polyethylene (VEPE) liners show low head penetration rates in cementless acetabular components. There is, however, currently no data on cemented VEPE acetabular components in total hip arthroplasty (THA). The aim of this study was to evaluate the safety of a new cemented VEPE component, compared with a conventional polyethylene (PE) component regarding migration, head penetration, and clinical results. Patients and Methods We enrolled 42 patients (21 male, 21 female) with osteoarthritis and a mean age of 67 years (sd 5), in a double-blinded, noninferiority, randomized controlled trial. The subjects were randomized in a 1:1 ratio to receive a reverse hybrid THA with a cemented component of either argon-gas gamma-sterilized PE component (controls) or VEPE, with identical geometry. The primary endpoint was proximal implant migration of the component at two years postoperatively measured with RSA. Secondary endpoints included total migration of the component, penetration of the femoral head into the component, and patient-reported outcome measurements. Results In total, 19 control implants and 18 implants in the VEPE group were analyzed for the primary endpoint. We found a continuous proximal migration of the component in the VEPE group that was significantly higher with a difference at two years of a mean 0.21 mm (95% confidence interval (CI) 0.05 to 0.37; p = 0.013). The total migration was also significantly higher in the VEPE group, but femoral head penetration was lower. We found no difference in clinical outcomes between the groups. Conclusion At two years, this cemented VEPE component, although having a low head penetration and excellent clinical results, failed to meet noninferiority compared with the conventional implant by a proximal migration above the proposed safety threshold of RSA. The early proximal migration pattern of the VEPE component is a reason for continued monitoring, although a specific threshold for proximal migration and risk for later failure cannot be defined and needs further study. Cite this article: Bone Joint J 2019;101-B:1192–1198

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Vitamin E-Enhanced Liners in Primary Total Hip Arthroplasty: A Systematic Review and Meta-Analysis

BioMed Research International ◽

10.1155/2021/3236679 ◽

2021 ◽

Vol 2021 ◽

pp. 1-10

Author(s):

Qian-Yue Cheng ◽

Bin-Fei Zhang ◽

Peng-Fei Wen ◽

Jun Wang ◽

Lin-Jie Hao ◽

...

Keyword(s):

Vitamin E ◽

Femoral Head ◽

Total Hip Arthroplasty ◽

Hip Arthroplasty ◽

Revision Rate ◽

Meta Analysis ◽

Harris Hip Score ◽

Head Penetration ◽

Total Hip ◽

Femoral Head Penetration

Objective. Adding vitamin E to highly cross-linked polyethylene liners is frequently performed in clinical practice, aiming at reducing liner wear, increasing liner survival, and delaying revision surgery. This study is aimed at evaluating the revision rate, total femoral head penetration, and postoperative clinical function of highly cross-linked polyethylene liners with and without vitamin E in total hip arthroplasty. Methods. We conducted a systematic literature search to identify the use of highly cross-linked vitamin E liners compared to other liners in patients who received total hip arthroplasty (THA) before April 2021. The study quality assessment and data collection were conducted by two independent reviewers. Studies were artificially grouped, and vitamin E-enhanced liners (VE-PE) were compared with vitamin E-free liners (non-VE-PE). Analyses were executed using Review Manager version 5.4.1. Results. From the preliminary screening of 568 studies, fourteen studies met the research criteria. Compared to non-VE-PE, using VE-PE reduced the all-cause revision rate ( odds ratio = 0.54 ; 95% confidence interval (CI) 0.40, 0.73; P < 0.0001 ). The total femoral head penetration of the VE-PE was lower than that of the non-VE-PE ( mean difference = − 0.10 ; 95% CI -0.17, -0.03; P = 0.007 ). However, there was no difference in clinical function, including the Harris Hip Score and EuroQol Five-Dimension Questionnaire scores. Conclusion. Compared to the liners without vitamin E, the addition of vitamin E to liners could reduce the all-cause revision rate by approximately 46% in the short-term follow-up. In addition, even though addition of vitamin E could also slow down femoral head penetration, there is no contribution to clinical function.

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Femoral head penetration in Vitamin-E polyethylene liner versus conventional liners in total hip arthroplasty: systematic review and meta-analysis of randomised control trials

SICOT-J ◽

10.1051/sicotj/2021045 ◽

2021 ◽

Vol 7 ◽

pp. 47

Author(s):

Hany Elbardesy ◽

Himanshu Yadav ◽

Mohamed Rabea ◽

Shane Guerin ◽

James Harty

Keyword(s):

Vitamin E ◽

Femoral Head ◽

Total Hip Arthroplasty ◽

Systematic Reviews ◽

Hip Arthroplasty ◽

Meta Analysis ◽

Polyethylene Liner ◽

Head Penetration ◽

Randomised Control Trials ◽

Femoral Head Penetration

Background: Debate encompasses the use of Vitamin E Polyethylene or conventional Polyethylene liner in primary hip arthroplasty. Does the Inclusion of Vitamin E in PE give adequate protection from oxidation and maintains lower rates of wear? Patients and methods: We performed this study following the Preferred Reporting Items for Systematic Reviews and Meta-analyses Statement (PRISMA) and the Cochrane Handbook for systematic reviews and meta-analysis. Studies were included from any region, written in any language. We had only the randomised control trials comparing the femoral head penetration between Vitamin-E diffused highly cross-linked polyethylene (VEPE) liner and conventional liners in primary total hip arthroplasty. Results: We included 10 studies in this meta-analysis. We conducted them using Review Manager V.5.0. We computed the risk ratio to measure the treatment effect, considering the heterogeneity. We used Random-effect models. VEPE had insignificant marginal advantages for FHP within three months post-operative. Additionally, VEPE showed significantly less FHP after two and five years. After one year, it showed significantly less FHP with the VEPE group versus the UHMWPE cohort and a non-significant difference between the VEPE and XLPE group. Conclusions: In terms of FHP, this metanalysis shows less FHP for the VEPE than conventional PE. A longer follow-up period is required to evaluate whether the oxidation protection gained by Vitamin E results in lower wear rates, less osteolysis, and aseptic loosening compared to the conventional PE in the long term.

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Vitamin E-doped total hip arthroplasty liners show similar head penetration to highly cross-linked polyethylene at five years: a multi-arm randomized controlled trial

The Bone & Joint Journal ◽

10.1302/0301-620x.102b10.bjj-2020-0138.r1 ◽

2020 ◽

Vol 102-B (10) ◽

pp. 1303-1310 ◽

Cited By ~ 1

Author(s):

Kristian Kjærgaard ◽

Ming Ding ◽

Carsten Jensen ◽

Charles Bragdon ◽

Henrik Malchau ◽

...

Keyword(s):

Vitamin E ◽

Femoral Head ◽

Total Hip Arthroplasty ◽

Aseptic Loosening ◽

Acetabular Component ◽

Hip Arthroplasty ◽

Harris Hip Score ◽

Head Penetration ◽

Total Hip ◽

Component Migration

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. Results Of 220 screened patients, 127 were included in this study. In all, 116 received the allocated intervention, and 94 had their results analyzed at five years. Head penetration was similar between liner materials and head sizes at five years, vE-PE versus XLPE was -0.084 mm (95% confidence interval (CI) -0.173 to 0.005; p = 0.064), and 32 mm versus 36 mm was -0.020 mm (95% CI -0.110 to 0.071; p = 0.671), respectively. No differences were found in acetabular component migration or in the patient-reported outcome measures. Conclusion No significant difference in head penetration was found at five years between vE-PE and XLPE liners, nor between 32 mm and 36 mm heads. Cite this article: Bone Joint J 2020;102-B(10):1303–1310.

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Comparison of Polyethylene Wear between Highly Crosslinked and Annealed UHMWPE and Conventional UHMWPE against Ceramic Heads in Total Hip Arthroplasty

Key Engineering Materials ◽

10.4028/www.scientific.net/kem.529-530.279 ◽

2012 ◽

Vol 529-530 ◽

pp. 279-284 ◽

Cited By ~ 1

Author(s):

Taishi Sato ◽

Yasuharu Nakashima ◽

Mio Akiyama ◽

Takuaki Yamamoto ◽

Taro Mawatari ◽

...

Keyword(s):

Femoral Head ◽

Total Hip Arthroplasty ◽

Hip Arthroplasty ◽

Polyethylene Wear ◽

Wear Rates ◽

Head Penetration ◽

Total Hip ◽

Patient Demographics ◽

Ceramic Femoral Head ◽

Implantation Period

The purpose of this study was to examine the effects of ceramic femoral head material on the wear of annealed, crosslinked ultra-high molecular weight polyethylene (UHMWPE) (XLPE) in total hip arthroplasty compared to non-crosslinked conventional UHMWPE (CPE). XLPE was fabricated by crosslinking with 60 kGy irradiation and annealing. Femoral heads made from zirconia and alumina ceramics, and cobalt-chrome (CoCr) of 22 mm or 26 mm diameter were used. In this study, the femoral head penetration into the cup was measured digitally on radiographs of 70 hips with XLPE and 50 hips with CPE. The average follow-up periods were 6.1 and 12.7 years, respectively. The steady wear rate of XLPE was significantly lower than those of CPE (0.002 versus 0.08 mm/year, respectively). Zirconia displayed increased wear rates compared to alumina in CPE; however, there was no difference among head materials in XLPE (0.0028, 0.011 and 0.009 mm/year for zirconia, alumina and CoCr, respectively). Neither head size or implantation period impacted XLPE wear. In contrast to CPE, XLPE displayed low wear rates surpassing the effects of varying femoral head material, size, implantation period and patient demographics.

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Radiolucent lines do not affect the longevity of highly cross-linked polyethylene cemented components in total hip arthroplasty

The Bone & Joint Journal ◽

10.1302/0301-620x.103b10.bjj-2020-2298.r2 ◽

2021 ◽

Vol 103-B (10) ◽

pp. 1604-1610

Author(s):

Yusuke Takaoka ◽

Koji Goto ◽

Jiro Tamura ◽

Yaichiro Okuzu ◽

Toshiyuki Kawai ◽

...

Keyword(s):

Femoral Head ◽

Total Hip Arthroplasty ◽

Acetabular Component ◽

Hip Arthroplasty ◽

Long Term Outcome ◽

Total Hip ◽

Radiolucent Lines ◽

Kaplan Meier ◽

Acetabular Components

Aims We aimed to evaluate the long-term outcome of highly cross-linked polyethylene (HXLPE) cemented acetabular components and assess whether any radiolucent lines (RLLs) which arose were progressive. Methods We retrospectively reviewed 170 patients who underwent 187 total hip arthroplasties at two hospitals with a minimum follow-up of ten years. All interventions were performed using the same combination of HXLPE cemented acetabular components with femoral stems made of titanium alloy. Kaplan-Meier survival analysis was performed for the primary endpoint of acetabular component revision surgery for any reason and secondary endpoint of the appearance of RLLs. RLLs that had appeared once were observed over time. We statistically assessed potential relationships between RLLs and a number of factors, including the technique of femoral head autografting and the Japanese Orthopaedic Association score. Results The mean follow-up period was 13.0 years (10.0 to 16.3). Femoral head autografting was performed on 135 hips (72.2%). One acetabular component was retrieved because of deep infection. No revision was performed for the aseptic acetabular loosening. The Kaplan-Meier survival curve for the primary and secondary endpoints were 98.2% (95% confidence interval (CI) 88.6% to 99.8%) and 79.3% (95% CI 72.8% to 84.6%), respectively. RLLs were detected in 38 hips (21.2%), at a mean of 1.7 years (1 month to 6 years) postoperatively. None of the RLLs were progressive, and the presence of RLLs did not show a significant association with the survival and clinical score. RLLs were more frequently observed in hips without femoral head autografts than in those with autografts. Conclusion The use of HXLPE cemented acetabular components in total hip arthroplasty demonstrated excellent clinical outcomes after ten years, and no RLLs were progressive, and their presence did not affect the outcome. Femoral head autografting did not negatively impact the acetabular component survival or the appearance of RLLs. Cite this article: Bone Joint J 2021;103-B(10):1604–1610.

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Mid-Term Results of Ceramic-on-Ceramic Total Hip Arthroplasty with Sandwich Cup

Key Engineering Materials ◽

10.4028/www.scientific.net/kem.309-311.1357 ◽

2006 ◽

Vol 309-311 ◽

pp. 1357-1362

Author(s):

Masahiro Hasegawa ◽

Akihiro Sudo ◽

Atsumasa Uchida

Keyword(s):

Total Hip Arthroplasty ◽

Hip Arthroplasty ◽

Hip Dislocation ◽

Clinical Results ◽

Total Hip ◽

The Mean ◽

Acetabular Components ◽

Mid Term Results ◽

Ceramic On Ceramic

In ceramic-on-ceramic total hip arthroplasty (THA), modular acetabular component with a sandwich insertion was developed and evaluated mid-term clinical results. 35 hips had undergone cementless ceramic-on-ceramic THA with sandwich cup (Kyocera, Kyoto, Japan). The mean duration of follow-up was 5 years. 6 hips had undergone component revisions. The reasons for revision included infection in 1 hip, dislocation with loosening in 2 hips, alumina liner fractures in 2 hips, and cup dissociation in 1 hip. All femoral and acetabular components showed no loosening in the unrevised hips at the time of the last follow-up. None of the 29 unrevised hips had osteolysis.

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Standing Versus Supine Radiographs to Evaluate Femoral Head Penetration in the Polyethylene Liner After Total Hip Arthroplasty

The Journal of Arthroplasty ◽

10.1016/j.arth.2014.02.010 ◽

2014 ◽

Vol 29 (12) ◽

pp. 2415-2419 ◽

Cited By ~ 3

Author(s):

Masaaki Maruyama ◽

Keiji Tensho ◽

Shinji Wakabayashi ◽

Kenji Hisa

Keyword(s):

Femoral Head ◽

Total Hip Arthroplasty ◽

Hip Arthroplasty ◽

Polyethylene Liner ◽

Head Penetration ◽

Total Hip ◽

Femoral Head Penetration

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A Novel Digital Templating Methodology for Arthroplasty: Experience from Patients with Osteonecrosis of the Femoral Head

Hip International ◽

10.5301/hipint.5000427 ◽

2017 ◽

Vol 27 (1) ◽

pp. 82-86 ◽

Cited By ~ 1

Author(s):

Ning Dong ◽

Chen Yang ◽

Shu-Qiang Li ◽

Yu-Hang Gao ◽

Jian-Guo Liu ◽

...

Keyword(s):

Retrospective Study ◽

Femoral Head ◽

Total Hip Arthroplasty ◽

Hip Arthroplasty ◽

External Rotation ◽

Femoral Rotation ◽

Digital Templating ◽

Stem Size ◽

Step Procedure ◽

Acetabular Components

Purpose To assess the accuracy of a novel digital templating methodology for total hip arthroplasty (THA) in patients with osteonecrosis of the femoral head (ONFH). Methods A retrospective study was carried out on 77 hips in 58 patients who had undergone uncemented THA for ONFH. Pre-Operative radiographs were templated using a 2-step procedure: (i) calculation of basic cup and stem sizes based on the anatomical morphology; (ii) adjustment of the basic sizes to account for variables such as femoral external rotation, osteoporotic changes in the femur, osteosclerotic changes in the acetabulum, and the type of stem. Basic and adjusted sizes were compared with the actual sizes of the implants used. Results Before adjustment, the overall accuracy was 69% and 70% for stem size and the cup respectively. Among all the cases, 31 femoral components (40%) and 17 acetabular components (22%) required adjustment. After adjustment, the accuracy of templating for stem and cup sizes in these adjusted cases improved from 52% to 87% (p = 0.002), and 41% to 82%, respectively (p = 0.032). And the overall templating accuracy improved to 83% on the stem side (p = 0.038) and 79% on the cup side (p = 0.195). Conclusions Pre-Operative digital templating was useful in predicting cup and stem sizes in patients with ONFH. Radiographic signs of femoral rotation or osteoporotic changes call for appropriate adjustment to improve the accuracy of templating for THA.

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