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      Hylan GF-20 Viscosupplementation in the Treatment of Symptomatic Osteoarthritis of the Knee: Clinical Effect Survivorship at 5 Years

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          Abstract

          Purpose

          Controversies remain surrounding the choice of hyaluronic acid products and patient selection. A study was conducted to report the long-term survivorship of intra-articular injection effect of high molecular weight hyaluronic preparation hylan GF-20 (Synvisc-One) for patients with symptomatic knee osteoarthritis.

          Materials and Methods

          A retrospective observational analysis of a single therapeutic series was carried out. The analysis was conducted to determine therapeutic effect survivorship taking arthroplasty and any other surgical interventions as endpoint results.

          Results

          Seventy-seven consecutive patients (82 knees) were followed up for five years. At one-year follow-up, 71 knees (87%) responded to treatment and only 8 knees (10%) were offered arthroplasty due to persistence of symptoms. At five-year follow-up, 41 (50%) were still considered responders. During the study period, repeat injection was given in 9 knees (11%). Arthroplasty (either total or unicompartmental) was required in 26 (31%). Kaplan-Meier survivorship analysis of therapeutic effect demonstrated 67% survival at 5 years with arthroplasty as endpoint and 58% survival at 5 years with all secondary interventions as endpoint.

          Conclusions

          This study demonstrates a significantly longer duration of clinical benefit of hylan GF-20 injection. Present results may suggest a notion of an ideal delay therapeutic strategy for patients not ready to receive an arthroplasty. Further studies will be required to help characterise these subsets of patients.

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          Most cited references24

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          Viscosupplementation for Osteoarthritis of the Knee: A Systematic Review of the Evidence.

          The purpose of this analysis was to determine the clinical significance of injectable hyaluronic acid (HA) in the treatment of knee osteoarthritis, and to assess which trial-level factors influence the overall treatment effect of HA on pain (as measured by a VAS [visual analog scale] or the WOMAC [Western Ontario and McMaster Universities Osteoarthritis Index]) and the WOMAC function and WOMAC stiffness subscales.
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            Therapeutic effects of hyaluronic acid on osteoarthritis of the knee. A meta-analysis of randomized controlled trials.

            The magnitude of the therapeutic effects of intra-articular injection of hyaluronic acid on osteoarthritis of the knee is still in question. The aim of this meta-analysis was to elucidate the therapeutic efficacy and safety of intra-articular injection of hyaluronic acid for osteoarthritis of the knee. We conducted a meta-analysis of twenty blinded randomized controlled trials that compared the therapeutic effect of intra-articular injection of hyaluronic acid with that of intra-articular injection of a placebo to treat osteoarthritis of the knee. The outcome end points were classified into three categories: pain with activities, pain without activities, and function. The outcome measures of the efficacy of hyaluronic acid were the mean differences in the efficacy scores between the hyaluronic acid and placebo groups. The outcome measure of the safety of hyaluronic acid was the relative risk of adverse events. Intra-articular injection of hyaluronic acid can decrease symptoms of osteoarthritis of the knee. We found significant improvements in pain and functional outcomes with few adverse events. However, there was significant between-study heterogeneity in the estimates of the efficacy of hyaluronic acid. Subgroup analysis and meta-regression analysis showed that lower methodological quality such as a single-blind or single-center design resulted in higher estimates of hyaluronic acid efficacy, that introduction of acetaminophen as an escape analgesic in the trial resulted in lower estimates of hyaluronic acid efficacy, and that patients older than sixty-five years of age and those with the most advanced radiographic stage of osteoarthritis (complete loss of the joint space) were less likely to benefit from intra-articular injection of hyaluronic acid. This meta-analysis confirmed the therapeutic efficacy and safety of intra-articular injection of hyaluronic acid for the treatment of osteoarthritis of the knee. Additional well-designed randomized controlled trials with high methodological quality are needed to resolve the continued uncertainty about the therapeutic effects of different types of hyaluronic acid products on osteoarthritis of the knee in various clinical situations and patient populations. Therapeutic study, Level II-3b (systematic review; nonhomogeneous Level-I studies). See Instructions to Authors for a complete description of levels of evidence.
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              Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs.

              Exposure to non-steroidal anti-inflammatory drugs (NSAIDs) is known to increase substantially the risk of upper gastrointestinal bleeding and perforation (UGIB). We have carried out a population-based retrospective case-control study to assess the variation in risk associated with various individual NSAIDs, with adjustment for features of use and other independent risk factors. The study sample comprised 1457 cases of UGIB and 10,000 control subjects identified from general practitioners' computerised records in the UK. The adjusted estimate of relative risk of UGIB associated with current NSAID use was 4.7 (95% CI 3.8-5.7). Previous UGIB was the single most important predictor of UGIB (relative risk 13.5 [10.3-17.7]). For all NSAIDs together, the risk was greater for high doses than for low doses (7.0 [5.2-9.6] vs 2.6 [1.8-3.8]). The estimates of risk associated with the individual NSAIDs varied widely. Users of azapropazone (23.4 [6.9-79.5]) and piroxicam (18.0 [8.2-39.6]) had the highest risk of UGIB among the NSAIDs studied. All the other NSAIDs with sufficient data for individual analysis (ibuprofen, naproxen, diclofenac, ketoprofen, and indomethacin) had relative risks similar to that for overall NSAID use. NSAIDS should be used cautiously in patients who have other risk factors for UGIB; these include advanced age, smoking, history of peptic ulcer, and use of oral corticosteroids or anticoagulants.
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                Author and article information

                Journal
                Knee Surg Relat Res
                Knee Surg Relat Res
                Knee Surgery & Related Research
                Korean Knee Society
                2234-0726
                2234-2451
                June 2017
                01 June 2017
                : 29
                : 2
                : 129-136
                Affiliations
                [1 ]Department of Trauma Orthopaedics, University Hospital Coventry and Warwickshire NHS Trust, Coventry, UK
                [2 ]Department of Trauma Orthopaedics, Alexandra Hospital, Redditch, UK
                Author notes
                Correspondence to: Tarek Boutefnouchet, MBChB, MRCS, PGCMed, MSc, Department of Trauma Orthopaedics, University Hospital Coventry and Warwickshire NHS Trust, Clifford Vridge Road, Coventry CV2 2DX, UK, Tel: +44-780-967-7302, Fax: +44-247-696-6262, E-mail: tboutefnouchet@ 123456hotmail.com
                Article
                ksrr-29-129
                10.5792/ksrr.16.061
                5450575
                28545178
                491970fa-699a-4aad-90b7-49858f1e939d
                Copyright © 2017 Korean Knee Society

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 17 October 2016
                : 06 February 2017
                : 27 February 2017
                : 13 March 2017
                : 23 April 2017
                Categories
                Original Article

                Surgery
                knee,osteoarthritis,intra-articular injections,viscosupplementation,hyaluronic acid,treatment outcome,survival

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