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1.
Vitamin E-blended highly cross-linked polyethylene liners in total hip arthroplasty: a randomized, multicenter trial using virtual CAD-based wear analysis at 5-year follow-up.
Busch, A, Jäger, M, Klebingat, S, Baghdadi, J, Flörkemeier, T, Hütter, F, Grupp, TM, , , Haversath, M
Archives of orthopaedic and trauma surgery. 2020;(12):1859-1866
Abstract
BACKGROUND Progressive oxidation of highly cross-linked ultra-high molecular weight (UHMPWE-X) liners is considered to be a risk factor for material failure in THA. Antioxidants such as vitamin E (alpha-tocopherol) (UHMWPE-XE) were supplemented into the latest generation of polyethylene liners. To prevent inhomogenous vitamin E distribution within the polymer, blending was established as an alternative manufacturing process to diffusion. The purpose of the present study was to investigate the in vivo wear behavior of UHMWPE-XE in comparison with conventional UHMWPE-X liners using virtual CAD-based radiographs. METHODS Until now, 94 patients from a prospective, randomized, controlled, multicenter study were reviewed at 5-year follow-up. Of these, 51 (54%) received UHMWPE-XE and 43 (46%) UHMWPE-X liners. Anteroposterior pelvic radiographs were made immediately after surgery and at 1 and 5 years postoperatively. The radiographs were analyzed using the observer-independent analysis software RayMatch® (Raylytic GmbH, Leipzig, Germany). RESULTS The mean wear rate was measured to be 23.6 μm/year (SD 13.7; range 0.7-71.8 μm). There were no significant differences between the two cohorts (UHMWPE-X: 23.2 μm/year vs. UHMWPE-XE: 24.0 μm/year, p = 0.73). Cup anteversion significantly changed within the 1st year after implantation independent from the type of polyethylene liner [UHMWPE-X: 18.2-23.9° (p = 0.0001); UHMWPE-XE: 21.0-25.5° (p = 0.002)]. No further significant changes of cup anteversion in both groups were found between year 1 and 5 after implantation [UHMWPE-X (p = 0.46); UHMWPE-XE (p = 0.56)]. CONCLUSION The present study demonstrates that the addition of vitamin E does not adversely affect the midterm wear behavior of UHMWPE-X. The antioxidative benefit of vitamin E is expected to become evident in long-term follow-up. Cup anteversion increment by 5° within the 1st year is likely a result of the released hip flexion contracture resulting in an enhanced posterior pelvic tilt. Therefore, a reassessment of target values in acetabular cup placement might be considered.
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2.
Results of a randomized controlled trial with five-year radiostereometric analysis results of vitamin E-infused highly crosslinked versus moderately crosslinked polyethylene in reverse total hip arthroplasty.
Thoen, PS, Nordsletten, L, Pripp, AH, Röhrl, SM
The bone & joint journal. 2020;(12):1646-1653
Abstract
AIMS: Vitamin E-infused highly crosslinked polyethylene (VEPE) has been introduced into total hip arthroplasty (THA) with the aim of further improving the wear characteristics of moderately and highly crosslinked polyethylenes (ModXLPE and HXLPE). There are few studies analyzing the outcomes of vitamin E-infused components in cemented arthroplasty, though early acetabular component migration has been reported. The aim of this study was to measure five-year polyethylene wear and acetabular component stability of a cemented VEPE acetabular component compared with a ModXLPE cemented acetabular component. METHODS In a prospective randomized controlled trial (RCT), we assessed polyethylene wear and acetabular component stability (primary outcome) with radiostereometric analysis (RSA) in 68 patients with reverse hybrid THA at five years follow-up. Patients were randomized to either a VEPE or a ModXLPE cemented acetabular component. RESULTS Mean polyethylene wear in the proximal direction was 0.17 mm (SD 0.15) for the VEPE group and 0.20 mm (SD 0.09) for the ModXLPE group (p = 0.005) at five years. Annual proximal wear rates were 0.03 mm/year (VEPE) and 0.04 mm/year (ModXLPE). Total 3D wear was 0.21 mm (SD 0.26) and 0.23 mm (SD 0.10) for the VEPE and ModXLPE groups, respectively (p = 0.009). Total 3D cup translation was 0.72 mm (SD 0.70) (VEPE) and 0.50 mm (SD 0.44) (ModXLPE) (p = 0.409). CONCLUSION At five years, there was less polyethylene wear in the VEPE group than in the ModXLPE group. Both VEPE and ModXLPE cemented components showed low annual wear rates. Component stability was similar in the two groups and remained constant up to five years. Whether these results will equate to a lower long-term revision rate is still unknown. Cite this article: Bone Joint J 2020;102-B(12):1646-1653.
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3.
Evaluation of vitamin E-diffused highly crosslinked polyethylene wear and porous titanium-coated shell stability: a seven-year randomized control trial using radiostereometric analysis.
Galea, VP, Rojanasopondist, P, Laursen, M, Muratoglu, OK, Malchau, H, Bragdon, C
The bone & joint journal. 2019;(7):760-767
Abstract
AIMS: Vitamin E-diffused, highly crosslinked polyethylene (VEPE) and porous titanium-coated (PTC) shells were introduced in total hip arthroplasty (THA) to reduce the risk of aseptic loosening. The purpose of this study was: 1) to compare the wear properties of VEPE to moderately crosslinked polyethylene; 2) to assess the stability of PTC shells; and 3) to report their clinical outcomes at seven years. PATIENTS AND METHODS A total of 89 patients were enrolled into a prospective study. All patients received a PTC shell and were randomized to receive a VEPE liner (n = 44) or a moderately crosslinked polyethylene (ModXLPE) liner (n = 45). Radiostereometric analysis (RSA) was used to measure polyethylene wear and component migration. Differences in wear were assessed while adjusting for body mass index, activity level, acetabular inclination, anteversion, and head size. Plain radiographs were assessed for radiolucency and patient-reported outcome measures (PROMs) were administered at each follow-up. RESULTS In total, 73 patients (82%) completed the seven-year visit. Mean seven-year linear proximal penetration was -0.07 mm (sd 0.16) and 0.00 mm (sd 0.22) for the VEPE and ModXLPE cohorts, respectively (p = 0.116). PROMs (p = 0.310 to 0.807) and radiolucency incidence (p = 0.330) were not different between the polyethylene cohorts. The mean proximal shell migration rate was 0.04 mm per year (sd 0.09). At seven years, patients with radiolucency (34%) demonstrated greater migration (mean difference: 0.6 mm (sd 0.2); p < 0.001). PROMs were lower for patients with radiolucency and greater proximal migration (p = 0.009 to p = 0.045). No implants were revised for aseptic loosening. CONCLUSION This is the first randomized controlled trial to report seven-year RSA results for VEPE. All wear rates were below the previously reported osteolysis threshold (0.1 mm per year). PTC shells demonstrated acceptable primary stability through seven years, as indicated by low migration and lack of aseptic loosening. However, patients with acetabular radiolucency were associated with higher shell migration and lower PROM scores. Cite this article: Bone Joint J 2019;101-B:760-767.
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4.
Evidence for the therapeutic effect of the organic content in Szigetvár thermal water on osteoarthritis: a double-blind, randomized, controlled clinical trial.
Hanzel, A, Berényi, K, Horváth, K, Szendi, K, Németh, B, Varga, C
International journal of biometeorology. 2019;(4):449-458
Abstract
The therapeutic effects of mineral waters have been attributed to the inorganic components alone; however, biologically active organic components are also present. We aimed to investigate whether the healing effect of Szigetvár thermal mineral water could relate to the organic matter in patients suffering from osteoarthritis of the hips and the knees. XAD macroreticular resins were used to prepare the organic fraction. Patients received a 30-min thermal water (34 °C) treatment in a bath tub, five times a week for 3 weeks. After randomization, patients were divided into three groups: tap water, mineral water, and organic fraction group. Primary outcomes were range of movement (ROM), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and visual analog scale (VAS) for pain severity, and the Short Form 36 (SF-36) questionnaire was used. These scores and indices were measured at baseline, after the last treatment, and at the end of the 3-month follow-up period. Seventy-four patients (age 67.3 ± 4.48 years) were enrolled: tap water n = 24, mineral water n = 26, and organic fraction n = 24. Treatment with the redissolved organic fraction significantly improved ROM, WOMAC, and SF-36 scores compared to the tap water. Our clinical trial provided evidence for the beneficial health effects of the organic fraction of Szigetvár medicinal water.
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5.
WHO/ILO work-related burden of disease and injury: Protocol for systematic reviews of exposure to occupational ergonomic risk factors and of the effect of exposure to occupational ergonomic risk factors on osteoarthritis of hip or knee and selected other musculoskeletal diseases.
Hulshof, CTJ, Colosio, C, Daams, JG, Ivanov, ID, Prakash, KC, Kuijer, PPFM, Leppink, N, Mandic-Rajcevic, S, Masci, F, van der Molen, HF, et al
Environment international. 2019;:554-566
Abstract
BACKGROUND The World Health Organization (WHO) and the International Labour Organization (ILO) are developing a joint methodology for estimating the national and global work-related burden of disease and injury (WHO/ILO joint methodology), with contributions from a large network of experts. In this paper, we present the protocol for two systematic reviews of parameters for estimating the number of disability-adjusted life years from osteoarthritis of hip or knee, and selected other musculoskeletal diseases respectively, attributable to exposure to occupational ergonomic risk factors to inform the development of the WHO/ILO joint methodology. OBJECTIVES We aim to systematically review studies on exposure to occupational ergonomic risk factors (Systematic Review 1) and systematically review and meta-analyze estimates of the effect of exposure to occupational ergonomic risk factors on osteoarthritis of the hip or knee, and selected other musculoskeletal diseases respectively (Systematic Review 2), applying the Navigation Guide systematic review methodology as an organizing framework, conducting both systematic reviews in tandem and in a harmonized way. DATA SOURCES Separately for Systematic Reviews 1 and 2, we will search electronic academic databases for potentially relevant records from published and unpublished studies, including Medline, EMBASE, Web of Science and CISDOC. We will also search electronic grey literature databases, Internet search engines and organizational websites; hand-search reference lists of previous systematic reviews and included study records; and consult additional experts. STUDY ELIGIBILITY AND CRITERIA We will include working-age (≥15 years) workers in the formal and informal economy in any WHO and/or ILO Member State, but exclude children (<15 years) and unpaid domestic workers. The included occupational ergonomic risk factors will be any exposure to one or more of: force exertion; demanding posture; repetitiveness; hand-arm vibration; lifting; kneeling and/or squatting; and climbing. Included outcomes will be (i) osteoarthritis and (ii) other musculoskeletal diseases (i.e., one or more of: rotator cuff syndrome; bicipital tendinitis; calcific tendinitis; shoulder impingement; bursitis shoulder; epicondylitis medialis; epicondylitis lateralis; bursitis elbow; bursitis hip; chondromalacia patellae; meniscus disorders; and/or bursitis knee). For Systematic Review 1, we will include quantitative prevalence studies of any exposure to occupational ergonomic risk factors stratified by country, gender, age and industrial sector or occupation. For Systematic Review 2, we will include randomized controlled trials, cohort studies, case-control-studies and other non-randomized intervention studies with an estimate of the relative effect of any exposure with occupational ergonomic risk factors on the prevalence or incidence of osteoarthritis and/or selected musculoskeletal diseases, compared with the theoretical minimum risk exposure level (i.e., no exposure). STUDY APPRAISAL AND SYNTHESIS METHODS At least two review authors will independently screen titles and abstracts against the eligibility criteria at a first stage and full texts of potentially eligible records at a second stage, followed by extraction of data from qualifying studies. At least two review authors will assess risk of bias and the quality of evidence, using the most suited tools currently available. For Systematic Review 2, if feasible, we will combine relative risks using meta-analysis. We will report results using the guidelines for accurate and transparent health estimates reporting (GATHER) for Systematic Review 1 and the preferred reporting items for systematic reviews and meta-analyses guidelines (PRISMA) for Systematic Review 2. PROSPERO registration number: CRD42018102631.
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6.
Wear of Vitamin E-Infused Highly Cross-Linked Polyethylene at Five Years.
Shareghi, B, Johanson, PE, Kärrholm, J
The Journal of bone and joint surgery. American volume. 2017;(17):1447-1452
Abstract
BACKGROUND In an earlier study with a 2-year follow-up of uncemented cups, we had reported low femoral-head penetration of vitamin E-infused highly cross-linked polyethylene liners (E1) compared with highly cross-linked liners without vitamin E (ArComXL). We studied the penetration rate of E1 compared with that of ArComXL, with a focus on changes occurring between 2 and 5 years after total hip arthroplasty. METHODS In this randomized controlled study, we performed radiostereometric analysis of the penetration rate up to 5 years in 63 hips. RESULTS During the total period of observation, the median proximal penetration for E1, 0.13 mm (mean, 0.11 mm [95% confidence interval (CI), 0.08 to 0.14 mm]), was lower than that for ArComXL, 0.20 mm (mean, 0.22 mm [95% CI, 0.17 to 0.26 mm]). The median proximal penetration rate between 2 and 5 years was 0.02 mm/yr (mean, 0.01 mm/yr [95% CI, 0.01 to 0.02 mm/yr]) for E1 and 0.04 mm/yr (mean, 0.04 mm/yr [95% CI, 0.03 to 0.05 mm/yr) for ArComXL. The corresponding median total (i.e., 3-dimensional resultant) penetration rates were 0.04 mm/yr (mean, 0.04 mm/yr [95% CI, 0.03 to 0.05 mm/yr]) for E1 and 0.07 mm/yr (mean, 0.08 mm/yr [95% CI, 0.06 to 0.10 mm/yr]) for ArComXL. CONCLUSIONS From years 2 to 5, we observed increased penetration in both groups. The penetration rate was higher for ArComXL, resulting in more proximal and total penetration at 5 years than for E1. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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7.
Effectiveness of rehabilitation after a total hip arthroplasty: a protocol for an observational study for the comparison of usual care in the Netherlands versus Germany.
Seeber, GH, Wijnen, A, Lazovic, D, Bulstra, SK, Dietz, G, van Lingen, CP, Stevens, M
BMJ open. 2017;(8):e016020
Abstract
INTRODUCTION Osteoarthritis is the most common joint disorder worldwide. Total hip arthroplasty (THA) is considered one of the most effective treatments for end-stage hip osteoarthritis. The number of THAs is expected to increase dramatically in the coming decades. Usual postoperative rehabilitation after primary THA differs between the German and the Dutch system. In the Netherlands, patients undergo fast-track surgery and are discharged into their home environment within a few days without receiving any aftercare. In Germany, patients stay in the hospital for about 12 days before being transferred to a rehabilitation centre for a period of 3 weeks. The superficially more cost-effective Dutch system of usual care after THA is judged critically in both countries due to suboptimal rehabilitation outcomes. The aim of this study is therefore to compare the Dutch with the German usual care rehabilitation after primary THA. It is hypothesised that the German procedure is more effective in terms of functional outcomes and patient satisfaction than the Dutch procedure and that in the long run the German approach is more cost-effective than the Dutch system. METHODS AND ANALYSIS Medical effectiveness will be assessed at four different time points by means of patient self-reported questionnaires and functional tests. Assessments include the Hip disability and Osteoarthritis Outcome Score, Patient Acceptable Symptom State, Short Form 36, EuroQol 5 Dimensions 3 Level Questionnaire, Timed Up & Go Test and Five Times Sit-to-Stand Test. Additionally, long-term economic aspects in both countries will be assessed from a societal perspective, to get a first impression on whether cutting costs for rehabilitation, as practised in the Netherlands, really disburdens the healthcare system efficiently. ETHICS AND DISSEMINATION The study is approved by the Institutional Review Boards of both University Medical Center Groningen (METc2015/483) and Hannover Medical School (no 2874-2015) and will be conducted according to the principles of the Declaration of Helsinki (64th, 2013). The results of the study will be published in international peer-reviewed scientific journals. Patient data will be presented anonymously in any publication or scientific journal. TRIAL REGISTRATION NUMBER DRKS00011345; Pre-results.
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8.
Equal Primary Fixation of Resurfacing Stem, but Inferior Cup Fixation With Anterolateral vs Posterior Surgical Approach. A 2-Year Blinded Randomized Radiostereometric and Dual-energy X-Ray Absorptiometry Study of Metal-on-Metal Hip Resurfacing Arthroplasty.
Hjorth, MH, Lorenzen, ND, Søballe, K, Jakobsen, SS, Stilling, M
The Journal of arthroplasty. 2017;(11):3412-3420
Abstract
BACKGROUND The anterolateral (AntLat) surgical approach may spare the blood supply to the femoral head and improve the accuracy of cup positioning in metal-on-metal hip resurfacing arthroplasty. Thereby, potentially lessen complications such as avascular head necrosis, femoral neck narrowing and fracture, improve implant fixation, and lessen periprosthetic bone mineral density (BMD) loss. METHODS Between November 2008 and January 2012, a randomized clinical trial was performed at Aarhus University Hospital. A total of 49 patients (28 males) were allocated to metal-on-metal hip resurfacing arthroplasty by the AntLat (n = 25) or the posterior (Post; n = 24) surgical approach. Patients were followed with radiostereometric analysis, measurements of periprosthetic BMD, clinical outcome scores of Harris hip score and visual analogue scale, serum metal ions, and conventional radiographs. RESULTS At 3 months, cups in the AntLat group had higher total translations of mean 1.00 ± 0.70 mm vs mean 0.64 ± 0.45 mm in the post group (P = .04), and higher total rotations of mean 2.44° ± 1.36° vs mean 1.39° ± 1.17° in the Post group (P = .002). All migrations of cup and stem were similar at 1 and 2 years postoperative (P > .07). At 1 year, periprosthetic BMD since postoperative at the medial side of the stem was reduced to mean 98.45% ± 8.57% in the AntLat group, and increased to mean 105.57% ± 11.07% in the Post group (P = .02), but measurements were comparable at 2 years (P = .05). CONCLUSION Cups inserted by the AntLat approach migrated more until 3 months postoperative. This illustrates a less good primary cup fixation with the AntLat approach; however, all cups were well-fixed after 3 months' follow-up indicating a good secondary fixation.
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9.
Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study.
Kovács, C, Bozsik, Á, Pecze, M, Borbély, I, Fogarasi, A, Kovács, L, Tefner, IK, Bender, T
International journal of biometeorology. 2016;(11):1675-1680
Abstract
The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls (p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.
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10.
3-year follow-up of a long-term registry-based multicentre study on vitamin E diffused polyethylene in total hip replacement.
Sillesen, NH, Greene, ME, Nebergall, AK, Huddleston, JI, Emerson, R, Gebuhr, P, Troelsen, A, Malchau, H
Hip international : the journal of clinical and experimental research on hip pathology and therapy. 2016;(1):97-103
Abstract
PURPOSE Preclinical studies of vitamin E diffused highly cross-linked polyethylene (E-XLPE) has shown enhanced mechanical properties with less wear. The purpose of our study was to document the early clinical outcome of E-XLPE to ensure, for the safety of patients, that there are no unforeseen early adverse events from using this new biomaterial. METHODS The enrolled patients (n = 977) have received either a porous titanium coated or porous plasma sprayed acetabular shell with either a E-XLPE liner or a medium cross-linked (AXL) liner. At each follow-up 5 patient-reported outcome measures (PROMs) were completed: Harris Hip Score, Case Mix Indicator, UCLA Activity Score, SF-36, and EQ-5D. Radiographs were measured for cup and stem position, as well as femoral head penetration into the liner (wear). Postoperative complications and revisions were collected. RESULTS At 3 years follow-up, there were 13 revisions due to: 4 periprosthetic fractures; 1 sepsis; 6 instabilities; and 2 implant mismatches at surgery. Wear of the hip implant, calculated by software analysis of pelvis x-rays, from the postoperative interval to 3 years showed a liner penetration rate of 0.027 mm/year for AXL and 0.005 mm/year for E-XLPE with no significant difference between the 2 (p = 0.24). Improvement was seen in all PROMs from the preoperative interval to 3 years after surgery (p<0.0001). CONCLUSIONS Early follow-up of the E-XLPE and AXL liners show low penetration. PROMs indicate improvement after total hip arthroplasty in functionality and quality of life across the centers. We have not observed any early in vivo adverse effects from diffusing the liners with vitamin E. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT00545285.