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      Hyaluronic Acid Injections Are Associated with Delay of Total Knee Replacement Surgery in Patients with Knee Osteoarthritis: Evidence from a Large U.S. Health Claims Database

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      PLoS ONE
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          Abstract

          Background

          The growing prevalence of osteoarthritis (OA) and the medical costs associated with total knee replacement (TKR) surgery for end-stage OA motivate a search for agents that can delay OA progression. We test a hypothesis that hyaluronic acid (HA) injection is associated with delay of TKR in a dose-dependent manner.

          Methods and Findings

          We retrospectively evaluated records in an administrative claims database of ~79 million patients, to identify all patients with knee OA who received TKR during a 6-year period. Only patients with continuous plan enrollment from diagnosis until TKR were included, so that complete medical records were available. OA diagnosis was the index event and we evaluated time-to-TKR as a function of the number of HA injections. The database included 182,022 patients with knee OA who had TKR; 50,349 (27.7%) of these patients were classified as HA Users, receiving ≥1 courses of HA prior to TKR, while 131,673 patients (72.3%) were HA Non-users prior to TKR, receiving no HA. Cox proportional hazards modelling shows that TKR risk decreases as a function of the number of HA injection courses, if patient age, gender, and disease comorbidity are used as background covariates. Multiple HA injections are therefore associated with delay of TKR (all, P < 0.0001). Half of HA Non-users had a TKR by 114 days post-diagnosis of knee OA, whereas half of HA Users had a TKR by 484 days post-diagnosis (χ 2 = 19,769; p < 0.0001). Patients who received no HA had a mean time-to-TKR of 0.7 years; with one course of HA, the mean time to TKR was 1.4 years (χ 2 = 13,725; p < 0.0001); patients who received ≥5 courses delayed TKR by 3.6 years (χ 2 = 19,935; p < 0.0001).

          Conclusions

          HA injection in patients with knee OA is associated with a dose-dependent increase in time-to-TKR.

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          Most cited references30

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          OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines.

          To develop concise, patient-focussed, up to date, evidence-based, expert consensus recommendations for the management of hip and knee osteoarthritis (OA), which are adaptable and designed to assist physicians and allied health care professionals in general and specialist practise throughout the world. Sixteen experts from four medical disciplines (primary care, rheumatology, orthopaedics and evidence-based medicine), two continents and six countries (USA, UK, France, Netherlands, Sweden and Canada) formed the guidelines development team. A systematic review of existing guidelines for the management of hip and knee OA published between 1945 and January 2006 was undertaken using the validated appraisal of guidelines research and evaluation (AGREE) instrument. A core set of management modalities was generated based on the agreement between guidelines. Evidence before 2002 was based on a systematic review conducted by European League Against Rheumatism and evidence after 2002 was updated using MEDLINE, EMBASE, CINAHL, AMED, the Cochrane Library and HTA reports. The quality of evidence was evaluated, and where possible, effect size (ES), number needed to treat, relative risk or odds ratio and cost per quality-adjusted life years gained were estimated. Consensus recommendations were produced following a Delphi exercise and the strength of recommendation (SOR) for propositions relating to each modality was determined using a visual analogue scale. Twenty-three treatment guidelines for the management of hip and knee OA were identified from the literature search, including six opinion-based, five evidence-based and 12 based on both expert opinion and research evidence. Twenty out of 51 treatment modalities addressed by these guidelines were universally recommended. ES for pain relief varied from treatment to treatment. Overall there was no statistically significant difference between non-pharmacological therapies [0.25, 95% confidence interval (CI) 0.16, 0.34] and pharmacological therapies (ES=0.39, 95% CI 0.31, 0.47). Following feedback from Osteoarthritis Research International members on the draft guidelines and six Delphi rounds consensus was reached on 25 carefully worded recommendations. Optimal management of patients with OA hip or knee requires a combination of non-pharmacological and pharmacological modalities of therapy. Recommendations cover the use of 12 non-pharmacological modalities: education and self-management, regular telephone contact, referral to a physical therapist, aerobic, muscle strengthening and water-based exercises, weight reduction, walking aids, knee braces, footwear and insoles, thermal modalities, transcutaneous electrical nerve stimulation and acupuncture. Eight recommendations cover pharmacological modalities of treatment including acetaminophen, cyclooxygenase-2 (COX-2) non-selective and selective oral non-steroidal anti-inflammatory drugs (NSAIDs), topical NSAIDs and capsaicin, intra-articular injections of corticosteroids and hyaluronates, glucosamine and/or chondroitin sulphate for symptom relief; glucosamine sulphate, chondroitin sulphate and diacerein for possible structure-modifying effects and the use of opioid analgesics for the treatment of refractory pain. There are recommendations covering five surgical modalities: total joint replacements, unicompartmental knee replacement, osteotomy and joint preserving surgical procedures; joint lavage and arthroscopic debridement in knee OA, and joint fusion as a salvage procedure when joint replacement had failed. Strengths of recommendation and 95% CIs are provided. Twenty-five carefully worded recommendations have been generated based on a critical appraisal of existing guidelines, a systematic review of research evidence and the consensus opinions of an international, multidisciplinary group of experts. The recommendations may be adapted for use in different countries or regions according to the availability of treatment modalities and SOR for each modality of therapy. These recommendations will be revised regularly following systematic review of new research evidence as this becomes available.
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            Treatment of osteoarthritis of the knee: evidence-based guideline, 2nd edition.

            Treatment of Osteoarthritis of the Knee: Evidence-Based Guideline, 2nd Edition, is based on a systematic review of the current scientific and clinical research. This guideline contains 15 recommendations, replaces the 2008 AAOS clinical practice guideline, and was reevaluated earlier than the 5-year recommendation of the National Guideline Clearinghouse because of methodologic concerns regarding the evidence used in the first guideline. The current guideline does not support the use of viscosupplementation for the treatment of osteoarthritis of the knee. In addition, the work group highlighted the need for better research in the treatment of knee osteoarthritis.
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              An algorithm recommendation for the management of knee osteoarthritis in Europe and internationally: a report from a task force of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO).

              Existing practice guidelines for osteoarthritis (OA) analyze the evidence behind each proposed treatment but do not prioritize the interventions in a given sequence. The objective was to develop a treatment algorithm recommendation that is easier to interpret for the prescribing physician based on the available evidence and that is applicable in Europe and internationally. The knee was used as the model OA joint.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                22 December 2015
                2015
                : 10
                : 12
                : e0145776
                Affiliations
                [1 ]Department of Rheumatology, University of California Los Angeles, Los Angeles, California, United States of America
                [2 ]North American Business Unit, Seikagaku Corporation, Tokyo, Japan
                [3 ]Department of Medical Affairs, Bioventus LLC, Durham, NC, United States of America
                [4 ]Department of Orthopaedics, Louisiana State University Health Sciences Center, New Orleans, Louisiana, United States of America
                University of Texas Health Science Center at Houston, UNITED STATES
                Author notes

                Competing Interests: This study was sponsored by Seikagaku Corporation of Tokyo, Japan. Mr. Lim is an employee of Seikagaku Corporation of Tokyo, Japan, and is an inventor and patent holder for a hyaluronic acid product (Patent title: Pharmaceutical composition for relieving pain; Patent number: US 8828969 B2). Dr. Steen is an employee of Bioventus LLC of Durham, North Carolina. Dr. Altman has been a consultant to Bioventus LLC for several years. Dr. Dasa has been a consultant for and is on the Speaker Board of Bioventus LLC. There are no further patents, products in development, or marketed products to declare. None of the authors has any other undescribed financial interests (stock ownership, patent applications, patent registrations, and research grants (or other funding) related to the work described. Seikagaku Corporation and Bioventus LLC did not play a role in study design, data collection, data analysis, or preparation of the manuscript; rather the companies paid salaries for Mr. Lim and Dr Steen, and this relationship has been made explicit by the involvement of Mr. Lim and Dr. Steen in all of the roles associated with authorship. This does not alter the authors' adherence to all the PLoS ONE policies on sharing data and materials.

                Conceived and designed the experiments: RA SL RGS VD. Performed the experiments: RA SL RGS VD. Analyzed the data: RA SL RGS VD. Wrote the paper: RA SL RGS VD.

                Article
                PONE-D-15-20433
                10.1371/journal.pone.0145776
                4687851
                26694145
                1a1cb82d-dafc-4672-b74e-ad414a0e82c4
                © 2015 Altman et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

                History
                : 12 May 2015
                : 8 December 2015
                Page count
                Figures: 2, Tables: 4, Pages: 13
                Funding
                This research was sponsored by the Seikagaku Corporation of Tokyo, Japan. Sooyeol Lim is employed by Seikagaku Corporation. Seikagaku Corporation provided support in the form of salary for author SL, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific role of this author is articulated in the ‘author contributions’ section. R. Grant Steen is employed by Bioventus LLC. Bioventus LLC provided support in the form of salary for author RGS, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific role of this author is articulated in the ‘author contributions’ section.
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