Knee OA cost comparison for hyaluronic acid and knee arthroplasty.

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.

Intra articular hyaluronic acid in the management of knee osteoarthritis: Pharmaco-economic study from the perspective of the national health insurance system.

INTRODUCTION: Pharmaco-economic data on the management of knee osteoarthritis (OA) with intra articular hyaluronic acid (IA HA) viscosupplementation is limited. We contrasted IA HA with non-steroidal anti-inflammatory drugs (NSAIDs). METHODS: Observational, prospective and multicenter study comparing treatments of knee OA costs and efficacy with either NSAIDs alone, or hyaluronic acid (Arthrum H 2%®), during a 6-month follow-up period. The investigators were pharmacists who recorded data on disease, drug consumption and healthcare circuit. Retrospectively, the 6-month period preceding inclusion was also studied, to ensure the comparability of groups. RESULTS: 199 patients were analyzed in a NSAIDs group and 202 in an IA HA group. Any of the WOMAC sub-scores and the EQ-5D Quality of Life index were significantly improved in the IA HA group (p<0.0001) at 3 and 6 months. Clinical results were therefore in favor of the IA HA group. The total drug expenses per 6-month period were comparable before and after inclusion, €96 and €98 for NSAIDs group vs €94 and €101 for IA HA group, which indicates no evidence of additional cost from IA HA. For the active part of the population, the incidence of sick leave was lower in the IA HA group, indicating a better maintenance of patient activity. The overall expense on 12 months (6 months before and 6 months after inclusion) for the national health insurance system was comparable for NSAIDs and IA HA groups: €528 and €526, respectively. The number of patients taking NSAIDs significantly decreased in IA HA group (from 100% at inclusion to 66% at 1-3 months and 44% at 4-6 months), but remained unchanged (100%) during the follow-up period, in NSAIDs group. CONCLUSION: Treatment with IA HA did not generate additional cost for the national health insurance and was associated with a functional improvement of knee osteoarthritis and Quality of Life. The cost-utility analysis was in favor of IA HA, with a gain of QALY equivalent to half a month, after the 6-month follow-up period comparing both treatments. The NSAIDs consumption was decreased in the IA HA group, resulting in an improved estimated benefit/risk ratio.

A randomized, open-label, multicenter study of the efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate versus dimethyl sulfoxide in women with bladder pain syndrome/interstitial cystitis.

AIMS: Intravesical instillation of hyaluronic acid (HA) plus chondroitin sulfate (CS) in women with bladder pain syndrome/interstitial cystitis (BPS/IC) has shown promising results. This study compared the efficacy, safety, and costs of intravesical HA/CS (Ialuril® , IBSA) to dimethyl sulfoxide (DMSO). METHODS: Randomized, open-label, multicenter study involving 110 women with BPS/IC. The allocation ratio (HA/CS:DMSO) was 2:1. Thirteen weekly instillations of HA (1.6%)/CS (2.0%) or 50% DMSO were given. Patients were evaluated at 3 (end-of-treatment) and 6 months. Primary endpoint was reduction in pain intensity at 6 months by visual analogue scale (VAS) versus baseline. Secondary efficacy measurements were quality of life and economic analyses. RESULTS: A significant reduction in pain intensity was observed at 6 months in both treatment groups versus baseline (P < 0.0001) in the intention-to-treat population. Treatment with HA/CS resulted in a greater reduction in pain intensity at 6 months compared with DMSO for the per-protocol population (mean VAS reduction 44.77 ± 25.07 vs. 28.89 ± 31.14, respectively; P = 0.0186). There were no significant differences between treatment groups in secondary outcomes. At least one adverse event was reported in 14.86% and 30.56% of patients in the HA/CS and DMSO groups, respectively. There were significantly fewer treatment-related adverse events for HA/CS versus DMSO (1.35% vs. 22.22%; P = 0.001). Considering direct healthcare costs, the incremental cost-effectiveness ratio of HA/CS versus DMSO fell between 3735€/quality-adjusted life years (QALY) and 8003€/QALY. CONCLUSIONS: Treatment with HA/CS appears to be as effective as DMSO with a potentially more favorable safety profile. Both treatments increased health-related quality of life, while HA/CS showed a more acceptable cost-effectiveness profile.

Hyaluronic Acid Injections for Treatment of Advanced Osteoarthritis of the Knee: Utilization and Cost in a National Population Sample.

BACKGROUND: The prevalence of knee osteoarthritis is increasing in the aging U.S. POPULATION: The efficacy and cost-effectiveness of the use of hyaluronic acid (HA) injections for the treatment of knee osteoarthritis are debated. In this study, we assessed the utilization and costs of HA injections in the 12 months preceding total knee arthroplasty (TKA) and evaluated the usage of HA injections in end-stage knee osteoarthritis management in relation to other treatments. METHODS: MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases (Truven Health Analytics) were reviewed to identify patients who underwent TKA from 2005 to 2012. The utilization of patient-specific osteoarthritis-related health care (including medications, corticosteroid injections, HA injections, imaging, and office visits) and payment information were analyzed for the 12 months preceding TKA. RESULTS: A total of 244,059 patients met the inclusion criteria. Of those, 35,935 (14.7%) had ≥1 HA injection in the 12 months preceding TKA. HA injections were responsible for 16.4% of all knee osteoarthritis-related payments, trailing only imaging studies (18.2%), and HA injections accounted for 25.2% of treatment-specific payments, a rate that was higher than that of any other treatment. Patients receiving HA injections were significantly more likely to receive additional knee osteoarthritis-related treatments compared with patients who did not receive HA injections. CONCLUSIONS: Despite numerous studies questioning the efficacy and cost-effectiveness of HA injections for osteoarthritis of the knee, HA injections are still utilized for a substantial percentage of patients. Given the paucity of data supporting the effectiveness of HA injections and the current cost-conscious health-care climate, decreasing their use among patients with end-stage knee osteoarthritis may represent a substantial cost reduction that likely does not adversely impact the quality of care.

Comparison of dextranomer/hyaluronic acid based bulking agents in the treatment of vesicoureteral reflux in children: Deflux versus Vurdex.

INTRODUCTION: The objective of this study was to compare the clinical efficacy of two similar tissue bulking agents, Deflux and Vurdex, used for a treatment of vesicoureteral reflux (VUR) in our institution. MATERIAL AND METHODS: The case records of 104 children, treated endoscopically for primary VUR from January 2010 to January 2015, were retrospectively reviewed. Most of the patients were treated with Deflux until 2012, when use of Vurdex was started. Exclusion criteria were patients with secondary reflux due to neurogenic bladder, duplicated refluxing ureters, primarily operated patients and patients operated after first or second injection. RESULTS: Endoscopic treatment of vesicoureteral reflux using Deflux was performed in 65 children (106 ureters). There were 24 patients with unilateral and 41 patients with bilateral VUR. After first injection of Deflux success was achieved in 74 ureters (69.8%), after second injection in 91 ureters (85.8%) and after third injection in 99 ureters (93.3%). The same procedure using Vurdex was performed in 39 children (58 ureters). There were 20 patients with unilateral and 19 patients with bilateral reflux. After first injection of Vurdex success was achieved in 43 ureters (74.1%), after second injection in 52 ureters (89.6%) and after third injection in 55 ureters (94.8%). CONCLUSIONS: Overall success rate for patients treated with Deflux was 93.3% and for patients treated with Vurdex 94.8%. No significant difference in success rates between two groups was found (p = 0.714). However, Vurdex has an advantage because of the significantly lower price, but with same treatment results as Deflux.

Cost-effectiveness analysis of arthroscopic surgery compared with non-operative management for osteoarthritis of the knee.

OBJECTIVE: To determine the cost-effectiveness of arthroscopic surgery in addition to non-operative treatments compared with non-operative treatments alone in patients with knee osteoarthritis (OA). DESIGN, SETTING AND PARTICIPANTS: We conducted an economic evaluation alongside a single-centre, randomised trial among patients with symptomatic, radiographic knee OA (KL grade ≥ 2). INTERVENTIONS: Patients received arthroscopic debridement and partial resection of degenerative knee tissues in addition to optimised non-operative therapy, or optimised non-operative therapy only. MAIN OUTCOME MEASURES: Direct and indirect costs were collected prospectively over the 2-year study period. The effectiveness outcomes were the Western Ontario McMaster Osteoarthritis Index (WOMAC) and quality-adjusted life years (QALYs). Cost-effectiveness was estimated using the net benefit regression framework considering a range of willingness-to-pay values from the Canadian public payer and societal perspectives. We calculated incremental cost-effectiveness ratios and conducted sensitivity analyses using the extremes of the 95% CIs surrounding mean differences in effect between groups. RESULTS: 168 patients were included. Patients allocated to arthroscopy received partial resection and debridement of degenerative meniscal tears (81%) and/or articular cartilage (97%). There were no significant differences between groups in use of non-operative treatments. The incremental net benefit was negative for all willingness-to-pay values. Uncertainty estimates suggest that even if willing to pay $400,000 to achieve a clinically important improvement in WOMAC score, or ≥$50,000 for an additional QALY, there is <20% probability that the addition of arthroscopy is cost-effective compared with non-operative therapies only. Our sensitivity analysis suggests that even when assuming the largest treatment effect, the addition of arthroscopic surgery is not economically attractive compared with non-operative treatments only. CONCLUSIONS: Arthroscopic debridement of degenerative articular cartilage and resection of degenerative meniscal tears in addition to non-operative treatments for knee OA is not an economically attractive treatment option compared with non-operative treatment only, regardless of willingness-to-pay value. TRIAL REGISTRATION NUMBER: NCT00158431.

Cost-effectiveness analysis of intra-articular injections of a high molecular weight bioengineered hyaluronic acid for the treatment of osteoarthritis knee pain.

OBJECTIVE: To determine the cost-effectiveness of bioengineered hyaluronic acid (BioHA, 1% sodium hyaluronate) intra-articular injections in treating osteoarthritis knee pain in poor responders to conventional care (CC) including non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics. METHODS: Two decision analytic models compared BioHA treatment with either continuation of patient's baseline CC with no assumption of disease progression (Model 1), or CC including escalating care costs due to disease progression (NSAIDs and analgesics, corticosteroid injections, and surgery; Model 2). Analyses were based on patients who received two courses of 3-weekly intra-articular BioHA (26-week FLEXX Trial + 26-week Extension Study). BioHA group costs included fees for physician assessment and injection regimen, plus half of CC costs. Cost-effectiveness ratios were expressed as averages and incremental costs per QALY. One-way sensitivity analyses used the 95% confidence interval (CI) of QALYs gained in BioHA-treated patients, and ±20% of BioHA treatment and CC costs. Probabilistic sensitivity analyses were performed for Model 2. RESULTS: For 214 BioHA patients, the average utility gain was 0.163 QALYs (95% CI = -0.162 to 0.488) over 52 weeks. Model 1 treatment costs were $3469 and $4562 for the BioHA and CC groups, respectively; sensitivity analyses showed BioHA to be the dominant treatment strategy, except when at the lower end of the 95% CI. Model 2 annual treatment costs per QALY gained were $1446 and $516 for the BioHA and CC groups, respectively. Using CC as baseline strategy, the incremental cost-effectiveness ratio (ICER) of BioHA was $38,741/QALY gained, and was sensitive to response rates in either the BioHA or CC groups. CONCLUSION: BioHA is less costly and more effective than CC with NSAIDs and analgesics, and is the dominant treatment strategy. Compared with escalating CC, the $38,741/QALY ICER of BioHA remains within the $50,000 per QALY willingness-to-pay threshold to adopt a new technology.

A randomized clinical trial of photodynamic therapy with methyl aminolaevulinate vs. diclofenac 3% plus hyaluronic acid gel for the treatment of multiple actinic keratoses of the face and scalp.

BACKGROUND: A gel containing diclofenac and hyaluronic acid (DHA) and photodynamic therapy with methyl aminolaevulinate (MAL-PDT) are widely used treatments for actinic keratoses (AKs). OBJECTIVES: The aim of this single-centre, open-label, prospective, nonsponsored, randomized controlled clinical trial was to compare the treatment results and cost-effectiveness of MAL-PDT and DHA. METHODS: Patients with multiple AKs of the face and scalp were randomized to receive MAL-PDT or DHA. After 90 days, the overall complete remission (CR) rate of patients and the CR rate of lesions according to thickness score were assessed, and patients and an investigator scored the cosmetic outcome. In addition, patients scored their overall satisfaction with the treatment. Patients with CR of all lesions were followed up for 12 months. RESULTS: Two hundred patients with a total of 1674 AKs were enrolled. The lesion CR rates at 3 months were 85·9% with MAL-PDT and 51·8% with DHA (P < 0·0001). AKs of all thicknesses were significantly more responsive to MAL-PDT. The patient CR rates at 3 months were 68% with MAL-PDT and 27% with DHA. At the 12-month examination, the number of patients with CR reduced to 37 with MAL-PDT and seven with DHA. Rating of cosmetic outcome was very good or excellent in the vast majority of patients with both treatments. The analysis of cost-effectiveness showed that the costs per patient with CR at 3 months and at 12 months are €566·7 and €1026·2, respectively, with MAL-PDT and €595·2 and €2295·6, respectively, with DHA. CONCLUSIONS: Efficacy, cosmetic outcome and patients' overall satisfaction with MAL-PDT are superior in comparison with DHA. MAL-PDT is more expensive but it is more cost-effective.

Treatment costs of bladder pain syndrome/interstitial cystitis in Austria: a pharmacoeconomic approach following current guidelines.

BACKGROUND: Bladder pain syndrome/interstitial cystitis (BPS/IC) is a chronic disease with a significant impact on quality of life. A broad range of therapies are used to treat this condition, and patients are often excluded from receiving more expensive and more effective therapies because of cost issues. OBJECTIVE: The objective of this study was to assess the mid- and long-term costs (over 1, 5 and 10 years) of various therapies for BPS/IC. METHODS: Costs in an open-access health system (Austria) for three BPS/IC-specific therapies (intravesical hyaluronan, pentosanpolysulfate and amitriptyline), taken from the American Urological Association guidelines, were evaluated and compared with those of non-specific symptomatic therapies. Response rates for the different therapies were taken from peer-reviewed publications and used to define the need for therapy maintenance with regard to symptom improvement. RESULTS: Despite the highest initial costs, the reduced need for further therapy in patients with long-term symptom remission after hyaluronan therapy resulted in the lowest total treatment costs at all three timepoints. Hyaluronan was cost saving against all alternatives in standard assumptions and in all sensitivity analyses. As a limitation, treatment costs in this study are specific for Austria. However, the template used for calculation of treatment costs can be transferred to all countries by inserting local prices. CONCLUSION: Disease-specific therapies with high remission rates result in significantly lower long-term costs in BPS/IC. Non-specific symptomatic therapies are most expensive. Long-term cost effectiveness is crucial in the treatment of chronic diseases to limit expenses in individual healthcare systems.

Efficacy of Seprafilm for preventing adhesive bowel obstruction and cost-benefit analysis in pediatric patients undergoing laparotomy.

PURPOSE: This aim of the study is to determine whether the use of Seprafilm reduces the incidence and the medical costs of adhesive bowel obstruction (ABO) in children. METHODS: Pediatric patients undergoing laparotomy were prospectively assigned to the Seprafilm group, n = 441). A historical control group consisted of children without using Seprafilm (n = 409). The incidence of ABO during a 24-month follow-up period was compared between the groups. To clarify the cost-benefit relations, expenses for Seprafilm and medical costs for hospitalization related to ABO in the Seprafilm group were compared with the ABO-associated hospitalization costs in the control group. RESULTS: The cumulative incidence rate of ABO in the control group was significantly higher than in the Seprafilm group (4.9% vs. 2.0%, p = 0.015). Nearly all cases that required adhesiolysis had adhesions to areas other than the incision in both groups. In cost-benefit analysis, cost per patient was $105 higher in the control group than in the Seprafilm group, but this did not reach significance (p = 0.63). CONCLUSIONS: Seprafilm reduces the incidence of ABO in the pediatric patients undergoing laparotomy. Although associated medical costs in the Seprafilm group were not significantly reduced, use of Seprafilm did not lead to an increase in cost. Wider range of Seprafilm application or an additional anti-adhesion device may help in preventing adhesion to areas other than the incision.

Hylan G-F 20 has better pain relief and cost-effectiveness than sodium hyaluronate in treating early osteoarthritic knees in Taiwan.

BACKGROUND/PURPOSE: Intra-articular injection of hyaluronan (hyaluronic acid; HA) products is available to treat early osteoarthritis (OA) of the knee in Taiwan. We tested whether HA products with different molecular weights have significantly different effects on clinical efficacy and cost-effectiveness. METHODS: Thirty-seven patients with mild to moderate OA of both knees underwent five weekly intra-articular injections of sodium hyaluronate (Artz) in one knee and three weekly intra-articular injections of chemically cross-linked Hylan G-F 20 (Synvisc) in the other. Visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne's index, and Hospital for Special Surgery (HSS) knee scores were compared initially and at the last injection, and at 8, 12, 16, 20, and 26 weeks after the first injection. RESULTS: VAS, WOMAC, WOMAC-A1 (pain when walking on a flat surface) scores before week 16, HSS scores before week 12, and Lequesne's index scores except at week 26 all showed that HA significantly improved the scores time-dependently. In VAS scores, Synvisc showed better improvement before week 20, while this effect appeared at week 12 for the WOMAC-A1 scores. The incremental cost-effectiveness ratio of the Taiwan National Health Insurance Program, of the patient, and both of these was lower for Synvisc, which also reduced the number of additional hospital visits for injections by two. CONCLUSION: Synvisc possesses better symptom-modifying ability and cost-utility in treating early OA of the knee in Taiwan.

Volumizing the brow with hyaluronic acid fillers.

BACKGROUND: Aging eyes often are treated by excision of apparent excess skin and fat and, in some instances, by elevation of the brow. The result of these traditional approaches is increased definition of the orbit, which is not of benefit for all patients. In some cases, the addition of volume in the periorbital area may provide a better-looking result than traditional surgical alternatives. OBJECTIVE: The author describes the use of hyaluronic acid (HA) fillers for improvement of the periorbital region. METHODS: Using local anesthetic, patients are provided with a preview of the aesthetic result of treatment with HA fillers to add volume to the brow. Most treatments are performed using HA fillers, which have the benefit of results that are both reversible and long-lasting. The author uses a fanning technique to inject small quantities of material. RESULTS: The use of these techniques results in a high degree of patient satisfaction. Occasional minor irregularities may occur, but these can be smoothed out by massage or blended by further injection. Results lasting two years are common and we have observed longevity of three years or more in some patients. Some brow configurations that falsely project emotional states, such as anxiety, may also be corrected. CONCLUSIONS: As in other types of cosmetic surgery, patient selection is key. In properly selected patients, increased fullness of the upper lids is preferable to the greater definition of the lids resulting from traditional surgical techniques. The longevity of treatment and reversibility of changes to the upper lids with HA fillers render this approach both cost-effective and safe.

Endoscopic subureteral injection is not less expensive than outpatient open reimplantation for unilateral vesicoureteral reflux.

PURPOSE: Extravesical ureteral reimplantation and subureteral Deflux injection are used to correct vesicoureteral reflux with success rates of 94% to 99% and up to 89%, respectively. It was reported that unilateral extravesical reimplantation may be performed safely in an outpatient setting. Given that, we analyzed total system reimbursement to compare planned outpatient unilateral extravesical reimplantation to subureteral Deflux injection in patients with unilateral vesicoureteral reflux. MATERIALS AND METHODS: Data were collected on consecutive patients undergoing outpatient procedures for unilateral vesicoureteral reflux. Assessment of total system reimbursement was made using a payer mix adjusted calculation of surgery plus anesthesia plus hospital reimbursement. This was compared per procedure and in terms of total system reimbursement for each approach to obtain a similar resolution rate. RESULTS: A total of 209 consecutive patients were identified, of whom 26 underwent subureteral Deflux injection and 183 underwent unilateral extravesical reimplantation. Mean operative time was 93 minutes for reimplantation and 45 minutes for injection. The mean volume of dextranomer-hyaluronic acid was 1.2 ml. Total initial system reimbursement per patient was $3,813 for reimplantation and $4,259 for injection. A 3% hospital admission rate for reimplantation increased the total to $3,945. Higher reimbursement for injection depended largely on the material expense for dextranomer-hyaluronic acid. CONCLUSIONS: In terms of total system reimbursement it is less expensive in our system to treat unilateral vesicoureteral reflux with unilateral extravesical reimplantation than with subureteral Deflux injection using dextranomer-hyaluronic acid. The ability to perform unilateral reimplantation as an outpatient procedure has shifted this relationship.

Viscosupplementation: managed care issues for osteoarthritis of the knee.

BACKGROUND: Osteoarthritis (OA) affects an estimated 49 million adults in North America, or nearly 1 of every 6 adults. More than 8 million North Americans have limited mobility to some extent because of OA. By 2030, an estimated 71 million North Americans will be diagnosed with OA, an increase of 45% over current figures. For one group-model health maintenance organization (HMO), the average cost of care for patients with OA was $543 per member, a total annual cost to the HMO of $4,728,425. Of this total amount, 46% was for inpatient care, 32% was for medication, and 22% was for ambulatory care. OBJECTIVE: To determine the impact of OA on managed care and discuss treatment options available to those with OA, particularly of the knee. SUMMARY: OA represents an advanced stage of an active, progressive disease process. We know from medical research that OA is the endpoint of a progression in tissue degradation that results in loss of cartilage structure and function. Relief of pain and preservation of joint tissue must evolve to encompass treatments that interfere with cartilage-degrading mechanisms that follow acute or chronic injury, restore normal cartilage and joint homeostasis, and arrest the progression of disease. Optimal future treatments will also reverse existing damage and restore normal cartilage structure and function. Viscosupplementation with an elastoviscous fluid containing polymers of hylan derivatives of the natural glycosaminoglycan hyaluronan is indicated for treating pain of OA of the knee that has not responded to or is contraindicated for conservative nonpharmacologic therapy and traditional analgesics. These analgesics include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and cyclooxygenase-2 (COX-2) inhibitors. Clinicians in the managed care setting may consider using viscosupplementation in patients (1) who have persistent pain despite their use of conservative nonpharmacologic and pharmacologic therapy (e.g., exercise, weight loss, physician therapy, bracing/orthotics, NSAIDs, COX-2 inhibitors, and intra-articular glucocorticoids); (2) who have compromised gastrointestinal (GI) function or who are at risk for GI bleeding due to the adverse events of NSAIDs; (3) who are taking concomitant anticoagulant therapy for any condition; (4) who have cardiovascular or renal risk factors that preclude use of COX-2 inhibitors; and (5) for whom surgery is not appropriate. Further study should be conducted with larger numbers of patients to help identify a subgroup of patients with OA in whom viscosupplementation may have even greater effects. Additional research should also concentrate on assessing the risks and benefits of extended treatments, because limited data are available concerning the effectiveness of multiple courses of therapy. CONCLUSION: OA is an important public health issue as the leading cause of disability in North America. As populations age, socioeconomic costs of OA will dramatically increase. Among available treatment options, viscosupplementation is a valuable alternative to more conservative therapy and has the benefit of circumventing the possible side effects of systemically administered pharmacologic agents. Viscosupplementation demonstrated efficacy in OA of the knee, and its use in the managed care arena may generate savings in hospitalizations and other costs.

Corticosteroid compared with hyaluronic acid injections for the treatment of osteoarthritis of the knee. A prospective, randomized trial.

BACKGROUND: Although both corticosteroid and hyaluronic acid injections are widely used to palliate the symptoms of knee osteoarthritis, little research involving a comparison of the two interventions has been done. We tested the hypothesis that there are no significant differences between Hylan G-F 20 (Synvisc) and the corticosteroid betamethasone sodium phosphate-betamethasone acetate (Celestone Soluspan) in terms of pain relief or improvement in function, as determined by validated scoring instruments. METHODS: One hundred patients with knee osteoarthritis were randomized to receive intra-articular injection of either Hylan G-F 20 or the corticosteroid, and they were followed for six months. The patients treated with Hylan G-F 20 received one course of three weekly injections. The patients treated with the corticosteroid received one injection at the time of enrollment in the study, and they could request one more injection any time during the study. An independent, blinded evaluator assessed the patients with the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), a modification of the Knee Society rating system, and the visual analog pain scale. RESULTS: Both the group treated with the corticosteroid and the group treated with Hylan G-F 20 demonstrated improvements from baseline WOMAC scores (a median decrease from 55 to 40 points and from 54 to 44 points, respectively; p < 0.01 for both). The scores according to the Knee Society system did not significantly improve for the patients who received the corticosteroid (median, 58 to 70 points; p = 0.06) or for those who received Hylan G-F 20 (median, 58 to 68 points; p = 0.15). The scores on the visual analog scale improved for patients receiving Hylan G-F 20 (median, 70 to 52 mm; p < 0.01) but not for the patients who received the corticosteroid (median, 64 to 52 mm; p = 0.28). However, no significant differences between the two treatment groups were found with respect to the WOMAC, Knee Society system, or visual analog scale results. Women demonstrated a significant improvement in only one of the six possible outcome-treatment combinations (the WOMAC scale), whereas men demonstrated significant improvements in five of the six outcomes (all measures except the Knee Society rating system). CONCLUSIONS: No differences were detected between patients treated with intra-articular injections of Hylan G-F 20 and those treated with the corticosteroid with respect to pain relief or function at six months of follow-up. Women demonstrated significantly less response to treatment than men did for both treatments on all three outcome scales. Such significant gender-related differences warrant further investigation.

Corneal endothelial cell protection with a dispersive viscoelastic material and an irrigating solution during phacoemulsification: low-cost versus expensive combination.

PURPOSE: To evaluate the protective effect on corneal endothelial cells of a low-cost and an expensive combination of a dispersive viscoelastic material and an irrigating solution during phacoemulsification. SETTING: Department of Ophthalmology, University of Vienna, Vienna, Austria. METHODS: This prospective randomized examiner- and patient-masked study comprised 90 eyes of 45 consecutive patients with age-related cataract in both eyes. For each patient, the first eye was randomly assigned to receive hydroxypropyl methylcellulose 2% (Ocucoat) and Ringer's solution (low-cost combination) or sodium chondroitin sulfate 4%-sodium hyaluronate 3% (Viscoat) and an enriched balanced salt solution (BSS Plus) (expensive combination) during phacoemulsification. The contralateral eye received the other treatment. Endothelial cell function was evaluated by measuring corneal thickness (CT) using partial coherence interferometry, morphology assessment, and endothelial cell counts. RESULTS: The acute postoperative increase in CT was +9.8 microm in the low-cost group and +10.9 microm in the expensive group; the difference between groups was not significant. After 1 month, the CT still differed significantly from baseline in the low-cost group. Three months after surgery, the CT had returned to baseline values in both groups. There was no significant between-group difference in endothelial cell counts or morphology. CONCLUSIONS: During phacoemulsification in a nonselected patient population, there was no difference in acute postoperative corneal edema and endothelial cell morphology after 3 months between a Viscoat and BSS Plus combination and an Ocucoat and Ringer's solution combination. Eyes receiving the expensive combination had marginally faster recovery of corneal swelling by 3 months. However, the cost of Viscoat and 500 mL BSS Plus is 5 times that of Ocucoat and Ringer's solution.

The cost-effectiveness of endoscopic injection of dextranomer/hyaluronic acid copolymer for vesicoureteral reflux.

PURPOSE: Vesicoureteral reflux is a risk factor for progressive renal damage associated with urinary tract infection. Mild to moderate reflux is routinely treated with long-term antibiotic prophylaxis to prevent recurrent infections and open surgical reimplantation for breakthrough infections despite antibiotic therapy. Endoscopic subureteral injection of implant material is a therapeutic alternative to long-term prophylaxis and open surgery but its widespread use in the United States has been prevented by the lack of a stable implant material. Dextranomer/hyaluronic acid copolymer has been shown to be a safe, effective and durable implant material and was recently approved in the United States. We estimate the effect on costs and cure rates of introducing endoscopic injection with dextranomer/hyaluronic acid copolymer as a treatment alternative in the United States. MATERIALS AND METHODS: We constructed a model that mimics current clinical practice of vesicoureteral reflux treatment for 6 years, and incorporates spontaneous resolution and surgical intervention rates obtained from 2 long-term followup studies. The treatment algorithm was established using medical data from the literature, and clinical management practices from a Delphi survey of 27 pediatric urologists and nephrologists across the United States. Endoscopic injection was introduced into the model as replacement to surgery or alternative to long-term antibiotic prophylaxis. The effectiveness of dextranomer/hyaluronic acid copolymer was calculated from 140 patients (208 ureters) with grade III reflux treated in a clinical study of 221 children in Sweden. RESULTS: With current practice, the average cost per patient in 6 years was 6,640 US dollars and 23.5% of patients continued to have reflux. Replacing open surgery with endoscopic injection led to similar cure rates (22.2% failures) but costs were reduced to 5,522 US dollars. When injection was performed after 1 year of antibiotic therapy failure rates were reduced to 8.5% but costs increased to 7,644 US dollars. CONCLUSIONS: Our results show that a persistent approach to endoscopic surgery can be expected to result in overall success that equals or exceeds open surgery at a lower cost. This finding is particularly true if open reimplant is reserved for patients with high grade or persistent vesicoureteral reflux.

Viscosupplementation for osteoarthritis.

Viscosupplementation therapy can restore the elastic and viscous properties of synovial fluid and thus recreate the intra-articular joint homeostasis that is disrupted in the degenerative joint. Hyaluronan (hyaluronic acid) products have been developed and used for viscosupplementation therapy in osteoarthritis. Viscosupplementation treatments using these products are well tolerated. Because viscosupplementation therapy is based on the concept of replenishing a normal physiological component of synovial fluid and cartilaginous tissue, exogenous administration of hyaluronic acid has the potential to have few side effects or local or systemic reactions. Viscosupplementation represents an alternative treatment for patients with osteoarthritis in which oral medications and/or surgery are not options or are ineffective.