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Background: Multiple interventions may be used to treat symptomatic knee osteoarthritis (OA), but concerns have been raised about the safety and efficacy of some therapies. Clinical trials have shown that hyaluronic acid (HA) can provide pain relief up to 6 months and possibly to 12 months, while real-world data has shown that pain medication and intra-articular corticosteroid (CS) injection utilization are reduced within 6 months after HA., Objective: To examine changes in prescription pain medication and CS utilization during 1 year after multimodal therapy that included high molecular weight, bio-fermentation derived HA (Bio-HA) use for knee OA., Methods: Commercial and Medicare Supplemental claims data (IBM MarketScan Research Databases) (1 January 2012, through 31 December 2018) was used to identify unilateral Bio-HA patients using multimodal therapy (any combination of CS injection, opioids, and non-opioid pain medication). Monthly therapy utilization was compared in the 12 months after Bio-HA therapy initiation to the 4-month intra-multimodal period., Results: A total of 13,999 patients underwent Bio-HA therapy with concurrent multimodal therapy. The number of filled opioid prescriptions decreased from 2,913.0/month to 2,861.5/month after Bio-HA, with a reduction in mean monthly prescriptions from 0.60 to 0.43 per user ( p  < 0.001). A number of opioid days supplied also decreased from 48,914/month to 39,730/month, with a decrease from 10.1/month to 6.0/month per user ( p  < 0.001). Bio-HA patients had prescription pain medication-free days for 71% of the time post-multimodal period compared to 53% during the intra-multimodal period ( p  < 0.001). The proportion of patients with CS injections after Bio-HA decreased from 53.8% to 29.6% ( p  < 0.001). Total monthly CS injections decreased from 2,292 to 663., Conclusions: Our data suggest that high molecular weight Bio-HA, as part of multimodal therapy, may be effective in providing longer-term pain relief with the reduction in pain therapy (CS injections and opioids) and increase in prescription pain medication-free days.

Objective: Case reports of severe acute localized reactions (SALR) following intraarticular (IA) hyaluronic acid (HA) injections for knee osteoarthritis (OA) have been described. We compared surrogate SALR measures between patients using hylan G-F 20 and specific non-hylan G-F 20 HA products., Design: Knee OA patients were identified from the Optum Clinformatics dataset (January 2006 to June 2016), stratified into hylan G-F 20 and non-hylan G-F 20 HA users, matched by single or multiple injection products. Occurrences of surrogate SALR measures including inflammation/infection, intraarticular corticosteroid (CS) injections, arthrocentesis/aspiration, arthrotomy/incision and drainage, and arthroscopy were evaluated within 3 days post-HA., Results: Based on 694,404 HA injections, inflammation/infection rate was rare within 3 days of HA (up to 0.03%), with no statistical differences between hylan G-F 20 and non-hylan G-F 20 groups (matched by single or multiple injection products). The risk of knee arthrotomy/incision and drainage, arthroscopy, or arthrocentesis for hylan G-F 20 (2 mL) 3 weekly injection patients was lower than Hyalgan/Supartz and Orthovisc patients, but greater than Euflexxa patients. Overall, we found that Hylan G-F 20 (2 mL) 3 weekly injection had lower SALR rates compared to Hyalgan/Supartz and Orthovisc. However, Hylan G-F 20 (2 mL) 3 weekly injection had slightly higher rates of SALR when compared to Euflexxa. Among the single injection products, Hylan G-F 20 (6 mL) single injection had lower rates of SALR than Monovisc and Gel-One., Conclusions: This study shows no clear correlation between avian-derived or cross-linked products and SALR and provides evidence against avian-derived products or crosslinking as a source for these reactions.

Objective: Concerns have been raised about severe acute localized reactions (SALR) following intra-articular (IA) hyaluronic acid (HA) injections for knee osteoarthritis (OA). We compared surrogate SALR measures between hylan G-F 20 and non-hylan G-F 20 HA patients and evaluated corresponding SALR risk factors for hylan G-F 20 patients., Design: Knee OA patients were identified from the Optum Clinformatics dataset (January 2006 to June 2016), stratified into hylan G-F 20 and non-hylan G-F 20 HA users. Occurrences of surrogate SALR measures including inflammation/infection, intra-articular corticosteroid (CS) injections, arthrocentesis/aspiration, and office visits were evaluated within 3 days of HA use. Risk factors were evaluated using logistic regression., Results: The cohort involved 748,428 HA patients (23.2% in the hylan G-F 20 group). Inflammation/infection rate was 0.001% for hylan G-F 20 and 0.002% for non-hylan G-F 20 HA groups. Risk of CS injection (any diagnosis) was greater for hylan G-F 20 patients by 28% ( P < 0.001). Combined rates of CS injection and arthrocentesis/aspiration (any diagnosis) were comparable for both groups (hylan G-F 20, 2.2%; non-hylan G-F 20 HA, 2.6%). The risk of any visit or studied responses was lower for the hylan G-F 20 cohort by 12% ( P < 0.001). Clinical characteristics, such as CS injections within 1 week before HA and fluoroscopic imaging, were associated with the outcomes., Conclusions: The diagnosis of inflammations or infections within 3 days of the HA injection was extremely rare. The overall risk of surrogate SALR measures was similar for hylan G-F 20 and non-hylan G-F 20 HA patients.

Aim: We studied changes in opioid prescriptions and corticosteroid injection use for knee osteoarthritis patients before and after intra-articular hyaluronic acid (HA) use and opioid prescriptions before and after knee arthroplasty (KA). Materials & methods:  A total of 1,017,578 knee osteoarthritis members were ascertained from a commercial claims database (Health Intelligence Company LLC, IL, USA) using ICD9/ICD10 diagnosis codes. Results:  Eighty two percent of HA patients did not fill opioid prescriptions postinjection, with 54% of opioid users discontinuing fills. Two-thirds of KA patients filled opioid prescriptions within 6 months postsurgery, with 78% of opioid users continuing fills and 62% of nonusers initiating use. Conclusion: Alternative therapies, such as HA, that reduce opioid use may alleviate opioid addiction risks for KA patients who use opioids in the pre- and postoperative periods.

Background: Limiting treatment to those recommended by the American Academy of Orthopaedic Surgeon Clinical Practice Guidelines has been suggested to decrease costs by 45% in the year prior to total knee arthroplasty, but this only focuses on expenditures leading up to, but not including, the surgery and not the entire episode of care. We evaluated the treatment costs following knee osteoarthritis (OA) diagnosis and determined whether these are different for patients who use intra-articular hyaluronic acid (HA) and/or knee arthroplasty., Methods: Claims data from a large commercial database containing de-identified data of more than 100 million patients with continuous coverage from 2012 to 2016 was used to evaluate the cumulative cost of care for over 2 million de-identified members with knee OA over a 4.5-year period between 2011 and 2015. Median cumulative costs were then stratified for patients with or without HA and/or knee arthroplasty., Results: Knee OA treatment costs for 1,567,024 patients over the 4.5-year period was $6.60 billion (mean $4210/patient) as calculated by the authors. HA and knee arthroplasty accounted for 3.0 and 61.5% of the overall costs, respectively. For patients who underwent knee arthroplasty, a spike in median costs occurred sooner for patients without HA use (around the 5- to 6-month time point) compared to patients treated with HA (around the 16- to 17-month time point)., Conclusions: Non-arthroplasty therapies, as calculated by the authors, accounted for about one third of the costs in treating knee OA in our cohort. Although some have theorized that limiting the use of HA may reduce the costs of OA treatment, HA only comprised a small fraction (3%) of the overall costs. Among patients who underwent knee arthroplasty, those treated with HA experienced elevated costs from the surgery later than those without HA, which reflects their longer time to undergoing knee arthroplasty. The ability to delay or avoid knee arthroplasty altogether can have a substantial impact on the cost to the healthcare system.

Objective: There is debate about the effectiveness of intra-articular (IA) hyaluronic acid (HA) injections. We asked the following questions: (1) What is the epidemiology of IA HA use in knee arthroplasty (KA) patients? (2) Is Synvisc associated with a delay to KA? (3) Is there a difference in the delay to KA with the number of HA courses?, Design: The Optum Clinformatics data set (2006-June 2016) was used to identify patients with knee osteoarthritis (OA). Patients who did not receive IA HA were identified, along with those who received Synvisc or non-Synvisc HA. The median duration from knee OA to KA was compared using quantile regression modeling with propensity score weighting. The trend in time to KA with each HA course was evaluated., Results: Of 4,027,848 knee OA patients, 141,305 patients underwent KA. Overall median time from knee OA diagnosis to KA was 1.2 years (average: 1.9 ± 1.9 years; interquartile range of 0.4-2.8 years). HA patients had significantly longer adjusted median time to KA by at least 7 months ( P < 0.001). After adjusting for the time to HA and number of injections, Synvisc patients had 1.7 months longer time to KA than non-Synvisc HA patients ( P < 0.001). There was a trend toward longer time to KA with more HA courses., Conclusions: Most KA patients did not use HA (73.7%) and when received, it was associated with a longer median time to KA by at least 7 months, though the cause and effect could not be examined. The delay to KA increased with more HA courses.

Background: Unicondylar knee arthroplasty (UKA) has superior functional outcomes compared to total knee arthroplasty (TKA) with good mid-term and long-term survival data from high-volume institutions. We sought to quantify the risk of complications, re-operation/revision, hospital re-admission for any reason, and mortality of knee arthroplasty patients in the US patient population using 2 large databases., Methods: UKA and TKA patients who were identified in the 2002-2011, 5% sample of Medicare data and 2004-2012 (June) MarketScan Commercial and Medicare Supplemental Databases were followed to evaluate the risk of complications, hospital re-admission for any reason, and mortality within 90 days of surgery. Survival probability defined by re-operation was calculated using the Kaplan-Meier method at 0.5, 2, 5, 7, and up to 10 years post-operatively., Results: Compared to UKA, complication rates for TKA patients were significantly higher, including wound complication, pulmonary embolism, stiffness, peri-prosthetic joint infection, myocardial infarction, re-admission, and death. Age was found to be a significant risk factor (P < .05) for all complications in the Medicare cohort, except stiffness (P = .839), and all complications in the MarketScan cohort, except re-admission (P = .418), whereas gender had a variable effect on complications based on age. Survivorship of UKA was lower than TKA at all time points. Additionally, younger age adversely affected implant survival. By 7 years post-surgery, UKA survivorship in the Medicare and MarketScan cohorts was 80.9% and 74.4%, respectively. In contrast, TKA survivorship for the same cohorts was 95.7% and 91.9% by the same time point., Conclusion: Patients undergoing UKA have fewer post-operative complications and re-admissions than those undergoing TKA. However, patients undergoing UKA have a higher rate of re-operation and revision at up to 10 years of follow-up. It appears that age, as well as surgeon and hospital volume significantly impacts implant survivorship while gender does not have a relation., Level of Evidence: Level III., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Publications on the prevalence of unicompartmental knee arthroplasty in the United States using a single database may have underestimated the "true" number of cases performed, given that several unicondylar knee arthroplasty (UKA) patients are <65 years and have private insurance. The prevalence of UKA in elderly (≥65 years) and younger (<65 years) populations was evaluated using the 2002 to 2011 5% sample of the Medicare data (Part B) and the 2004 to June 2012 MarketScan Commercial and Medicare Supplemental databases, respectively. The prevalence of UKA was stratified by age, gender, census region, Charlson comorbidity index, Medicare buy-in status, and diagnosis. The annual rate of change in the UKA rate was examined using Poisson regression to evaluate temporal changes considering year as a covariate. A total of 5235 and 23,310 UKA procedures were identified from the 5% Medicare and MarketScan databases, respectively. The rates of UKA generally increased until 2008, after which there was a decline. In both cohorts, gender and year of operation were found to be significantly associated with UKA rate. Analysis of data obtained over the past few years revealed that males 55 to 64 years, 65 to 69 years, and 70 to 74 years were the only age-gender groups whose UKA rates appeared to be trending upward. From 2002 to 2011, the rate of UKAs performed in the United States has increased, and a significant proportion of the surgeries were performed in younger (<65 years) patients., Competing Interests: Authors' Disclosure Statement: This article was funded in part by a research grant provided by Mako Surgical. Dr. Lonner reports being a consultant for ZimmerBiomet, Smith and Nephew, Force Therapeutics, and Muvr Labs and receiving royalties from ZimmerBiomet and Smith and Nephew. He is a shareholder in Force Therapeutics and Muvs Labs. The other authors report no actual or potential conflict of interest in relation to this article.

Background: Few nonoperative treatment options for knee osteoarthritis (OA) are available, but there is ongoing debate about the effectiveness of intra-articular (IA) hyaluronic acid (HA) injections. We investigated whether the formulation of IA HA, or its combined use with IA corticosteroid (CS), may be contributing to some of the reported variation in clinical outcomes., Methods: The 5% Part B Medicare data (2005-2012) were used to identify knee OA patients who underwent knee arthroplasty (KA). The time from diagnosis of OA to KA was compared between patients with (HA) and without (no HA) IA HA use, using quantile regression with propensity score adjustment. These were further stratified by type of IA HA. Patient factors associated with time to KA were also assessed using Cox regression., Results: The "HA" cohort was associated with a longer time to KA of 8.7 months (95% confidence interval: 8.3-9.1 months; P < .001) compared with the "no HA" cohort, with extended time to KA in the bioengineered Euflexxa IA HA cohort. Patient factors associated with longer time to KA included women, younger patients, minority patients, patients with fewer comorbidities, and IA CS injection use. Patients with both IA HA and IA CS had an additional 6.3 months (95% confidence interval: 5.5-7.0 months; P < .001) to KA over those with only IA HA., Conclusion: In a large cohort of elderly patients undergoing KA, there was a significant longer time from diagnosis of OA to KA in those receiving IA HA. It is unclear if the extended time may lead to less KA utilization., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Introduction: Hyaluronic acid (HA) and corticosteroid (CS) injections are frequently used in the management of osteoarthritis (OA) of the knee, despite a lack of strong evidence supporting their efficacy in the literature. The purpose of this study is to evaluate trends in HA and CS usage in Medicare patients over the past 15 years., Methods: The Medicare 5% national sample database was used to identify 581,022 patients (representing an estimated 11.6 million) with a diagnosis of knee OA between 1999 and 2013., Results: The percentage of newly diagnosed knee OA patients who received any injection trended from 39% in 1999 to 47% in 2006 and then declined to 37.5% in 2013. However, the mean number of injections per newly diagnosed OA patient nearly doubled from 0.27 to 0.45 for CS and from 0.18 to 0.36 for HA. Among those having both HA and CS injections, 69% had CS as first-line treatment, whereas 31% had HA first., Conclusion: The percentage of newly diagnosed knee OA patients receiving injections peaked in 2007 and then decreased steadily through 2013, as did the proportion of patients receiving HA injections as first-line therapy. However, the number of injections per patient has increased significantly over the past 15 years in both groups., (Copyright © 2016 Elsevier Inc. All rights reserved.)

There are little data that quantify the long term costs, mortality, and downstream disease after Total Knee Arthroplasty (TKA). The purpose of this study is to compare differences in cost and health outcomes between Medicare patients with OA who undergo TKA and those who avoid the procedure. The Medicare 5% sample was used to identify patients diagnosed with OA during 1997-2009. All OA patients were separated into non-arthroplasty and arthroplasty groups. Differences in costs, mortality, and new disease diagnoses were adjusted using logistic regression for age, sex, race, buy-in status, region, and Charlson score. The 7-year cumulative average Medicare payments for all treatments were $63,940 for the non-TKA group and $83,783 for the TKA group. The risk adjusted mortality hazard ratio (HR) of the TKA group ranged from 0.48 to 0.54 through seven years (all P<0.001). The risk of heart failure in the TKA group was 40.9% at 7years (HR=0.93, P<0.001). The results demonstrate the patients in the TKA cohort as having a lower probability of heart failure and mortality, at a total incremental cost of $19,843., (Copyright © 2013 Elsevier Inc. All rights reserved.)