Impact of depressive symptoms on direct medical cost among medicare recipients with knee osteoarthritis.

OBJECTIVE: Depressive symptoms are prevalent among knee osteoarthritis (KOA) patients and may lead to additional medical costs. We compared medical costs in Medicare Current Beneficiary Survey (MCBS) respondents with KOA with and without self-reported depressive symptoms. METHODS: We identified a KOA cohort using ICD-9/10 diagnostic codes in both Part A and Part B claims among community-dwelling MCBS respondents from 2003 to 2019. We determined the presence of depressive symptoms using self-reported data on sadness or anhedonia. We considered three groups: 1) without depressive symptoms, 2) with depressive symptoms, no billable services, and 3) with depressive symptoms and billable services. We used a generalized linear model with log-transformed outcomes to compare annual total direct medical costs among the three groups, adjusting for age, gender, race, history of fall, Total Joint Replacement, comorbidities, and calendar year. RESULTS: The analysis included 4118 MCBS respondents with KOA. Of them, 27% had self-reported depressive symptoms, and 6% reported depressive symptoms and received depression-related billable services. The adjusted mean direct medical costs were $8598/year for those without depressive symptoms, $9239/year for those who reported depressive symptoms and received no billable services, and $14,229/year for those who reported depressive symptoms and received billable services. CONCLUSION: While over one quarter of Medicare beneficiaries with KOA self-reported depressive symptoms, only 6% received billable medical services. The presence of depressive symptoms led to higher direct medical costs, even among those who did not receive depression-related billable services.

The economics of a national anterior cruciate ligament injury prevention program for amateur football players: a Markov model analysis.

OBJECTIVES: To estimate the long term cost savings, return on investment, and gain in quality-adjusted life years (QALYs) that could be achieved by a national anterior cruciate ligament (ACL) injury prevention program for amateur football (soccer) players in Australia. STUDY DESIGN: Markov model decision analysis. SETTING, PARTICIPANTS: Two hypothetical scenarios including all amateur football players in Australia (340 253 players): no intervention, and a national ACL injury prevention program. Transitions between health states, including ACL rupture, meniscal injury, knee osteoarthritis, and total knee replacement were made in one-year cycles over 35 years from a societal perspective. MAIN OUTCOME MEASURES: Cost savings, return on investment, and QALY gain achieved in the prevention program scenario relative to control scenario, by age group (10-17, 18-34, 35 years or older) and gender. SECONDARY OUTCOMES: incidence of ACL rupture, knee osteoarthritis, total knee replacement, and total knee replacement revision. RESULTS: The total mean cost of an ACL injury was estimated to be $30 665. The national injury prevention program was projected to save $52 539 751 in medical and societal costs caused by ACL ruptures in amateur footballers over 35 years; the estimated return on each dollar invested in the program was $3.51. Over this period, the number of players with ruptured ACLs could be reduced by 4385 (9%), the number of knee osteoarthritis cases by 780 (8.1%), and the number of total knee replacements by 121 (8.1%); 445 QALYs were gained. CONCLUSION: Our findings support investing in a national, evidence-based program for the primary prevention of ACL injuries in amateur football players.

Significant Cost Savings and Improved Early Clinical Outcomes in Medicare Patients Utilizing a Clinician-Controlled Telerehabilitation System Following Total Knee Arthroplasty.

BACKGROUND: The costs and benefits of different rehabilitation protocols following total knee arthroplasty are unclear. The emergence of telerehabilitation has introduced the potential for enhanced patient convenience and cost reduction. The purpose of this study was to assess the cost difference between standard physical therapy (SPT) and a telerehabilitation home-based clinician-controlled therapy system (HCTS). METHODS: A prospectively enrolled, consecutive series of 109 Medicare patients who received SPT were compared to 101 Medicare patients who were treated with a HCTS. The analysis focused on total rehabilitation costs and the assessment of outcome measures: knee range of motion, visual analog scale pain levels, and Knee Injury and Osteoarthritis Outcome Score for Joint Replacement. RESULTS: The HCTS group demonstrated not only statistically significantly lower average costs but also faster and sustained knee range of motion improvements. Furthermore, in comparison to SPT, the HCTS group exhibited superior visual analog scale pain scores and Knee Injury and Osteoarthritis Outcome Score for Joint Replacement functional scores at all assessment points postoperatively, which were statistically significant (all P < .001) and surpassed the minimal clinically important difference thresholds. CONCLUSIONS: The HCTS used in this study exhibited a remarkable cost-saving advantage of $2,460 per patient compared to standard therapy. As approximately 500,000 primary total knee arthroplasties in the United States are covered by Medicare annually, a switch to HCTS could yield total cost savings of more than $1.23 billion per year for our taxpayer-funded health care system. Furthermore, the HCTS cohort demonstrated superior functional outcomes and improved pain scores across all assessment time points, exceeding the minimal clinically important difference.

Are education, exercise and diet interventions a cost-effective treatment to manage hip and knee osteoarthritis? A systematic review.

OBJECTIVE: To identify research gaps and inform implementation we systematically reviewed the literature evaluating cost-effectiveness of recommended treatments (education, exercise and diet) for the management of hip and/or knee OA. METHODS: We searched Medline, Embase, Cochrane Central Register of Controlled Trials, National Health Services Economic Evaluation Database, and EconLit from inception to November 2019 for trial-based economic evaluations investigating hip and/or knee OA core treatments. Two investigators screened relevant publications, extracted data and synthesized results. Risk of bias was assessed using the Consensus on Health Economic Criteria list. RESULTS: Two cost-minimization, five cost-effectiveness and 16 cost-utility analyses evaluated core treatments in six health systems. Exercise therapy with and without education or diet was cost-effective or cost-saving compared to education or physician-delivered usual care at conventional willingness to pay (WTP) thresholds in 15 out of 16 publications. Exercise interventions were cost-effective compared to physiotherapist-delivered usual care in three studies at conventional WTP thresholds. Education interventions were not cost-effective compared to usual care or placebo at conventional WTP thresholds in three out of four publications. CONCLUSIONS: Structured core treatment programs were clinically effective and cost-effective, compared to physician-delivered usual care, in five health care systems. Providing education about core treatments was not consistently cost-effective. Implementing structured core treatment programs into funded clinical pathways would likely be an efficient use of health system resources and enhance physician-delivered usual primary care.

Wait times, resource use and health-related quality of life across the continuum of care for patients referred for total knee replacement surgery.

Background: The escalating socioeconomic burden of knee osteoarthritis (OA) underscores the need for innovative strategies to reduce wait times for total knee arthroplasty (TKA). The purpose of this study was to evaluate resource use, costs and health-related quality of life (HRQoL) across the continuum of care for patients with knee OA. Methods: This was a prospective study of 383 patients recruited from a high-volume teaching hospital at different stages of care (referral, consultation and presurgery). Outcomes included health care resource use; costs captured from the health care payer, private sector and societal perspectives; HRQoL measured using the Western Ontario and McMaster Universities Osteoarthritis Index, the 12-Item Short Form Health Survey, and EuroQoL 5-Dimension 5-Level tool; wait times; and the proportion of referrals deemed suitable candidates for surgery. Results: The most commonly used conservative treatments were pharmacotherapy, exercise and lifestyle modification. Forty percent of patients referred for TKA were deemed not to be suitable candidates for surgery. The greatest proportion of costs was borne by the patient or private insurer; a small proportion was borne by the public payer. Across all stages of care, more than 60% of the total costs was attributed to productivity losses. HRQoL remained relatively stable throughout the waiting period (mean wait time from referral to TKA 13.2 mo) but improved postoperatively. Conclusion: The suboptimal primary care management of knee OA calls for the development of innovative models of care. This study may provide valuable guidance on the design and implementation of a new online educational platform to improve referral efficiency and expedite wait times for TKA.

Contexte: Le fardeau socioéconomique croissant de l'arthrose du genou rappelle que nous avons besoin de stratégies novatrices afin de réduire les temps d'attente pour l'arthroplastie totale du genou (ATG). Le but de cette étude est d'évaluer l'utilisation des ressources, les coûts et la qualité de vie liée à la santé (QVLS) dans tout le continuum des soins pour les patients souffrant d'arthrose du genou. Méthodes: Cette étude prospective a porté sur 383 patients recrutés dans un établissement d'enseignement fort achalandé, qui en étaient à différentes étapes du continuum de soins (demande de consultation, consultation et préchirurgie). Les paramètres incluaient l'utilisation des ressources en santé, les coûts du point de vue sociétal et des régimes d'assurance maladie publics et privés, la QVLS mesurée au moyen de l'indice WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), du questionnaire Short Form Health Survey en 12 points et de l'outil EuroQoL appliqué à 5 dimensions et à 5 niveaux, les temps d'attente, et la proportion de demandes de consultation concernant des patients considérés comme de bons candidats à la chirurgie. Résultats: Les traitements conservateurs les plus utilisés étaient la pharmacothérapie, l'exercice et les modifications à l'hygiène de vie. Quarante pour cent des patients adressés en consultation pour ATG ont été considérés comme de bons candidats à la chirurgie. La plus grande part des coûts a été assumée par le patient ou un assureur privé; une faible part des coûts a été assumée par le régime public. À toutes les étapes du continuum, plus de 60 % des coûts totaux ont été attribués à des pertes de productivité. La QVLS est demeurée relativement stable tout au long de la période d'attente (temps d'attente moyen entre la consultation et l'ATG, 13,2 mois) mais s'est améliorée après la chirurgie. Conclusion: La prise en charge sous-optimale de l'arthrose du genou en soins primaires rappelle qu'il est nécessaire d'établir des modèles de soins novateurs. Cette étude pourrait faciliter la mise au point et l'application d'une nouvelle plateforme éducative en ligne pour améliorer l'efficience des demandes de consultation et abréger les temps d'attente pour l'ATG.

Long-term clinical and economic outcomes of a short-term physical activity program in knee osteoarthritis patients.

OBJECTIVE: Physical activity (PA) in the US knee osteoarthritis (OA) population is low, despite well-established health benefits. PA program implementation is often stymied by sustainability concerns. We sought to establish parameters that would make a short-term (3-year efficacy) PA program a cost-effective component of long-term OA care. METHOD: Using a validated computer microsimulation (Osteoarthritis Policy Model), we examined the long-term clinical (e.g., comorbidities averted), quality of life (QoL), and economic impacts of a 3-year PA program, based upon the SPARKS (Studying Physical Activity Rewards after Knee Surgery) Trial, for inactive knee OA patients. We determined the cost, efficacy, and impact of PA on QoL and medical costs that would make a PA program a cost-effective addition to OA care. RESULTS: Among the 14 million with knee OA in the US, >4 million are inactive. Participation of 10% in the modeled PA program could save 200 cases of cardiovascular disease, 400 cases of diabetes, and 6,800 quality-adjusted life-years (QALYs). The program had an incremental cost-effectiveness ratio (ICER) of $16,100/QALY. Tripling PA program cost ($860/year) raised the ICER to $108,300/QALY; varying QoL benefits from PA yielded ICERs of $8,800/QALY-$99,900/QALY; varying background cost savings from PA did not qualitatively impact ICERs. Offering the PA program to any adults with knee OA (not only inactive) yielded $31,000/QALY. CONCLUSION: A PA program with 3-year efficacy in the knee OA population carried favorable long-term clinical and economic benefits. These results offer justification for policymakers and payers considering a PA intervention incorporated into knee OA care.

Patients', healthcare providers', and insurance company employees' preferences for knee and hip osteoarthritis care: a discrete choice experiment.

OBJECTIVE: To determine patients', healthcare providers', and insurance company employees' preferences for knee and hip osteoarthritis (KHOA) care. DESIGN: In a discrete choice experiment, patients with KHOA or a joint replacement, healthcare providers, and insurance company employees were repetitively asked to choose between KHOA care alternatives that differed in six attributes: waiting times, out of pocket costs, travel distance, involved healthcare providers, duration of consultation, and access to specialist equipment. A (panel latent class) conditional logit model was used to determine preference heterogeneity and relative importance of the attributes. RESULTS: Patients (n = 648) and healthcare providers (n = 76) valued low out of pocket costs most, while insurance company employees (n = 150) found a joint consultation by general practitioner (GP) and orthopaedist most important. Patients found the duration of consultation less important than healthcare providers and insurance company employees did. Patients without a joint replacement were likely to prefer healthcare with low out of pocket costs. Patients with a joint replacement and/or low disease-specific quality of life were likely to prefer healthcare from an orthopaedist. Patients who already received healthcare for knee/hip problems were likely to prefer a joint consultation by GP and orthopaedist, and direct access to specialist equipment. CONCLUSIONS: Patients, healthcare providers, and insurance company employees highly prefer a joint consultation by GP and orthopaedist with low out of pocket costs. Within patients, there is substantial preference heterogeneity. These results can be used by policy makers and healthcare providers to choose the most optimal combination of KHOA care aligned to patients' preferences.

Cost-effectiveness of 12 weeks of supervised treatment compared to written advice in patients with knee osteoarthritis: a secondary analysis of the 2-year outcome from a randomized trial.

OBJECTIVE: To assess the 24-month cost-effectiveness of supervised treatment compared to written advice in knee osteoarthritis (OA). DESIGN: 100 adults with moderate-severe OA not eligible for total knee replacement (TKR) randomized to a 12-week individualized, supervised treatment (exercise, education, diet, insoles and pain medication) or written advice. Effectiveness was measured as change in quality-adjusted life years (QALYs) from baseline to 24 months, including data from baseline, 3, 6, 12 and 24 months, while healthcare costs and transfer payments were derived from national registries after final follow-up. Incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated. A sensitivity analysis resampling existing data was conducted and the probability of cost-effectiveness was estimated using a 22,665 Euros/QALY threshold. In a sensitivity analysis, cost-effectiveness was calculated for different costs of the supervised treatment (actual cost in study; cost in private practice; and in-between cost). RESULTS: Average costs were similar between groups (6,758 Euros vs 6,880 Euros), while the supervised treatment were close to being more effective (incremental effect (95% CI) of 0.075 (-0.005 to 0.156). In the primary analysis excluding deaths, this led the supervised treatment to be cost-effective, compared to written advice. The sensitivity analysis demonstrated that the results were sensitive to changes in the cost of treatment, but in all scenarios the supervised treatment was cost-effective (ICERs of 6,229 to 20,688 Euros/QALY). CONCLUSIONS: From a 24-month perspective, a 12-week individualized, supervised treatment program is cost-effective compared to written advice in patients with moderate-severe knee OA not eligible for TKR. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT01535001.

Socioeconomic status of patients in a Swedish national self-management program for osteoarthritis compared with the general population-a descriptive observational study.

BACKGROUND: First-line treatment for hip and knee osteoarthritis (OA) including education and supervised exercises, delivered as a self-management program, is considered one of the mainstays in OA treatment. However, the socioeconomic profile of the population that utilizes first-line treatment for hip and knee OA is unclear. The aim of this study was to describe the socioeconomic status (SES) of a population referred to a self-management program for OA, in comparison with that of the general Swedish population. METHODS: This is a cross-sectional study including 72,069 patients with hip or knee OA enrolled in the National Quality Register for Better management of patients with Osteoarthritis (BOA) between 2008 and 2016, and registered before participation in a structured OA self-management program. A reference cohort (n = 216,207) was selected from the general Swedish population by one-to-three matching by year of birth, sex and residence. Residential municipality, country of birth, marital status, family type, educational level, employment, occupation, disposable income and sick leave were analyzed. RESULTS: The BOA population had higher educational level than the reference group, both regarding patients with hip OA (77.5% vs 70% with ≥10 years of education), and with knee OA (77% vs 72% with ≥10 years of education). Their average disposable income was higher (median [IQR] in Euro (€), for hip €17,442 [10,478] vs €15,998 [10,659], for knee €17,794 [10,574] vs €16,578 [11,221]). Of those who worked, 46% of patients with hip OA and 45% of the reference group had a blue-collar occupation. The corresponding numbers for knee OA were 51 and 44% respectively. Sick leave was higher among those with hip and knee OA (26%) than those in the reference groups (13% vs 12%). CONCLUSIONS: The consistently higher SES in the BOA population compared with the general population indicates that this self-management program for OA may not reach the more socioeconomically disadvantaged groups, who are often those with a higher disease burden.

What Is the Appropriate Price for Platelet-Rich Plasma Injections for Knee Osteoarthritis? A Cost-Effectiveness Analysis Based on Evidence From Level I Randomized Controlled Trials.

PURPOSE: To identify the price of treatment at which platelet-rich plasma (PRP) is cost-effective relative to hyaluronic acid (HA) and saline solution intra-articular injections. METHODS: A systemized review process of the PubMed, Embase, and MEDLINE databases was undertaken to identify randomized controlled trials comparing PRP with HA and saline solution with up to 1 year of follow-up. Level I trials that reported Western Ontario and McMaster Universities Arthritis Index Likert scores were included. These scores were converted into utility scores. Cost data were obtained from Centers for Medicare & Medicaid Services fee schedules. Total costs included the costs of the injectable, clinic appointments, and procedures. The change in utility scores from baseline to 6 months and 1 year for the PRP, HA, and saline solution groups was divided by total cost to determine utility gained per dollar and to identify the price needed for PRP to be cost-effective relative to these other injection options. RESULTS: Nine randomized controlled trials met the inclusion criteria. A total of 882 patients were included: 483 in the PRP group, 338 in the HA group, and 61 in the saline solution group. Baseline mean utility scores ranged from 0.55 to 0.57 for the PRP, HA, and saline solution groups. The 6-month gains in utility were 0.12, 0.02, and -0.06, respectively. The 12-month gains in utility from before injection were 0.14, 0.03, and 0.06, respectively. The lowest total costs for HA and saline solution were $681.93 and $516.29, respectively. For PRP to be cost-effective, the total treatment cost would have to be less than $3,703.03 and $1,192.08 for 6- and 12-month outcomes, respectively. CONCLUSIONS: For patients with symptomatic knee osteoarthritis, PRP is cost-effective, from the payer perspective, at a total price (inclusive of clinic visits, the procedure, and the injectable) of less than $1,192.08 over a 12-month period, relative to HA and saline solution. LEVEL OF EVIDENCE: Level I, systematic review.

Comparative clinical and cost analysis between surgical and non-surgical intervention for knee osteoarthritis.

OBJECTIVE: To evaluate the management and costs of osteoarthritis of the knee (OAK), a progressive joint disease due to bone and cartilage degeneration, with significant personal and societal impact. METHODS: We prospectively analyzed the clinical outcomes and quantifiable cumulative direct costs of patients with OAK referred to our multidisciplinary OA program over a two year time period. One hundred thirty-one subjects were assessed. All demonstrated radiographic criteria for moderate to severe OAK. Western Ontario McMaster Osteoarthritis Index (WOMAC), Minimal Clinically Important Improvement (MCII), and change in BMI were recorded and analyzed. Total medical and surgical direct costs for all subjects during the two year time period were determined. RESULTS: Five patients underwent total joint replacement during the two years of study. Among the group as a whole, a significant overall improvement in WOMAC scores was noted at the two year time point follow-up. After dividing the group into tertiles by baseline WOMAC scores, 46% achieved MCII. Significant weight loss was noted for individuals with baseline BMI of > 30. As all patients were considered "de facto" surgical candidates at referral, an average net savings of $9551.10 of direct costs per patient, or a potential total of $1,203,438.60 for the entire group, could be inferred as a result of medical as opposed to surgical management. CONCLUSION: These findings support the benefits of multidisciplinary medical management for patients with significant OAK. This approach is clinically beneficial and may provide significant cost savings. Such models of care can substantially improve the long-term outcome of this highly prevalent condition and reduce societal and financial burdens.

Health resource use and costs of symptomatic knee and/or hip osteoarthritis.

BACKGROUND: Data on the economic consequences of hip and knee osteoarthritis (OA) are scarce. We aimed to estimate the annual direct and indirect costs for patients followed for hip and/or knee OA in the Knee and Hip Osteoarthritis Long term Assessment (KHOALA) cohort. METHODS: The KHOALA cohort, set up from 2007 to 2009, is a French multicenter study of 878 individuals with symptomatic knee/hip OA who were 40-75 years old. Resources used were collected annually for 5 years. Costs were assigned by using official sources and expressed in 2018 euros per patient. RESULTS: The mean annual total costs per patient over the 5-year study period were 2,180 ± 5,305€. The mean annual direct medical costs per patient were 2,120 ± 5,275€ and mean annual indirect costs per patient 180 ± 1,735€ for people of working age. Costs increased slightly over the study period. Drugs were the largest cost share, representing over 50% of all direct costs. However, the proportion attributable to OA drugs accounted for only 10.5% of drug costs. The second cost share was hospitalizations; hip and knee prosthetic surgery accounted for 27% of surgery hospitalization costs. Health professional visits were the third cost share, accounting for 3% of direct medical costs. The median costs induced could be as high as 2 billion €/year (IQR 0.7-4.3) in France. CONCLUSION: Hip and knee OA costs were substantial and increased over the study period in France. However, the costs attributable to OA represented only a small fraction of overall costs.

Incremental clinical effectiveness and cost effectiveness of providing supervised physiotherapy in addition to usual medical care in patients with osteoarthritis of the hip or knee: 2-year results of the MOA randomised controlled trial.

OBJECTIVE: To investigate the clinical- and cost-effectiveness at 2-year follow-up of providing individual, supervised exercise physiotherapy and/or manual physiotherapy in addition to usual medical care. METHOD: People with hip or knee osteoarthritis meeting the American College of Rheumatology clinical diagnostic criteria were randomised (1:1, concealed, assessor-blinded) to four groups: usual medical care; supervised exercise physiotherapy; manual physiotherapy; or combined exercise and manual physiotherapy. Physiotherapy group participants were provided 10 50-min treatment sessions including booster sessions at 4 and 13 months, in addition to usual care. The primary outcome at 2-year follow-up was incremental cost-utility ratio (ICUR) of each physiotherapy intervention in addition to usual care, compared with usual care alone, from the health system and societal perspectives. To allow interpretation of negative ICURs, we report incremental net benefit (INB). The primary clinical outcome was the Western Ontario and McMaster Osteoarthritis Index (WOMAC). RESULTS: Of 206 patients, 186 (90·3%) were retained at 2-year follow-up. Exercise physiotherapy and manual physiotherapy dominated usual care, demonstrating cost savings; combined therapy did not. Exercise therapy had the highest incremental net benefits (INBs), statistically significant at all willingness-to-pay (base-case: societal New Zealand (NZ)$6,312, 95%CI 334 to 12,279; health system NZ$8,065, 95%CI 136 to 15,994). Clinical improvements were superior to usual care only in the exercise physiotherapy group (-28.2 WOMAC points, 95%CI -49.2 to -7.1). No serious adverse events were recorded. CONCLUSION: Individually supervised exercise therapy is cost-effective and clinically effective in addition to usual medical care at 2-year follow-up, and leads to cost savings for the health system and society. TRIAL REGISTRATION: Prospectively registered with the Australian NZ Clinical Trials Registry, reference ACTRN12608000130369.

EQ-5D-5L utilities per health states in Spanish population with knee or hip osteoarthritis.

BACKGROUND: The objective of this study was to obtain utilities by means of EQ-5D-5L for different health states in patients with knee osteoarthritis (KOA) or hip osteoarthritis (HOA) in Spain, and to compare these values with those used in foreign studies with the aim of discussing their transferability for their use in economic evaluations conducted in Spain. METHODS: Primary study: Observational prospective study of KOA or HOA patients in Spain. Sociodemographic and clinical characteristics were collected to characterize the sample. Utilities were elicited using the EQ-5D-5L questionnaire. ANOVA and bivariable analyses were conducted to identify differences between health states. LITERATURE REVIEW: Using the bibliographic databases NSH EED and CEA Registry, we conducted searches of model-based cost utilities analyses of technologies in KOA or HOA patients. Health states and utilities were extracted and compared with values obtained from the Spanish sample. RESULTS: Three hundred ninety-seven subjects with KOA and 361 subjects with HOA were included, with average utilities of 0.544 and 0.520, respectively. In both samples, differences were found in utilities according to level of pain, stiffness and physical function (WOMAC) and severity of symptoms (Oxford scales), so that the worst the symptoms, the lower the utilities. The utilities after surgery were higher than before surgery. Due to limitations from our study related to sample size and observational design, it was not possible to estimate utilities for approximately half the health states included in the published models because they were directly related to specific technologies. For almost 100% of health states of the selected studies we obtained very different utilities from those reported in the literature. CONCLUSIONS: To our knowledge this is the first article with detailed utilities estimated using the EQ-5D-5L in Spain for KOA and HOA patients. In both populations, utilities are lower for worse health states in terms of level of pain, stiffness and physical function according to WOMAC, and according to the Oxford scales. Most utilities obtained from the Spanish sample are lower than those reported in the international literature. Further studies estimating utilities from local populations are required to avoid the use of foreign sources in economic evaluations.

Functional outcome of total knee replacement: a study protocol for a prospective, double-blinded, parallel-group randomized, clinical controlled trial of novel, personalized and conventional implants.

BACKGROUND: The development of total knee replacement (TKR) implant designs aims to improve outcome regarding pain, function, joint stiffness, instability, patellar problems, and ultimately wear of the implant. Recently, two major orthopaedic implant manufacturers launched a new generation of TKR implants which, according to the manufacturers, provide improved functional outcome. However, the benefits of these new TKR designs claimed by the manufacturers in terms of improved functional outcome still lack scientific documentation. The present randomized controlled trial has been designed to compare three fixed bearing, cemented cruciate-retaining (CR) designs; one of the new personalized TKR design with two conventional TKR designs with the main emphasis being on functional outcome. METHODS: The present study is a prospective, double-blinded, randomized, single-center intervention trial. A total of 240 patients will be recruited to participate in a parallel-group study at Coxa Hospital for Joint Replacement, Tampere, Finland. We will compare the short-term functional outcome of TKR performed with a novel personalized TKR design (Persona CR, Zimmer, Warsaw, IN, USA) against TKRs performed with two conventional designs (PFC CR, DePuy, Warsaw, IN, USA and Nexgen CR, Zimmer, Warsaw, IN, USA). In total, 80 patients will be randomized in each of the three study arms. The primary outcome in this study is the Oxford Knee Score (OKS), which is a validated patient-reported outcome measure (PROM). Secondary outcome measures include the Forgotten Joint Score, the 15D, the UCLA activity score, and the VAS pain scale. The results will be analyzed after 2-year follow-up. DISCUSSION: This paper presents a prospective, randomized, single-center trial study protocol. It provides details of patient randomization, PROMs, follow-up, methods of analysis of the material, and publication plan. An important aspect that will be considered in the study will be the economic effects of the novel designs as they are substantially more expensive, and the benefits of the added costs remain unknown. In addition, it is especially important to carry out evaluative studies in independent centers that are not biased by the interests of the manufacturers. TRIAL REGISTRATION: Retrospectively registered, November, 2017, ClinicalTrials.gov Identifier: NCT03339557 .

The projected burden of primary total knee and hip replacement for osteoarthritis in Australia to the year 2030.

BACKGROUND: Comprehensive national joint replacement registries with well-validated data offer unique opportunities for examining the potential future burden of hip and knee osteoarthritis (OA) at a population level. This study aimed to forecast the burden of primary total knee (TKR) and hip replacements (THR) performed for OA in Australia to the year 2030, and to model the impact of contrasting obesity scenarios on TKR burden. METHODS: De-identified TKR and THR data for 2003-2013 were obtained from the Australian Orthopaedic Association National Joint Replacement Registry. Population projections and obesity trends were obtained from the Australian Bureau of Statistics, with public and private hospital costs sourced from the National Hospital Cost Data Collection. Procedure rates were projected according to two scenarios: (1) constant rate of surgery from 2013 onwards; and (2) continued growth in surgery rates based on 2003-2013 growth. Sensitivity analyses were used to estimate future TKR burden if: (1) obesity rates continued to increase linearly; or (2) 1-5% of the overweight or obese population attained a normal body mass index. RESULTS: Based on recent growth, the incidence of TKR and THR for OA is estimated to rise by 276% and 208%, respectively, by 2030. The total cost to the healthcare system would be $AUD5.32 billion, of which $AUD3.54 billion relates to the private sector. Projected growth in obesity rates would result in 24,707 additional TKRs totalling $AUD521 million. A population-level reduction in obesity could result in up to 8062 fewer procedures and cost savings of up to $AUD170 million. CONCLUSIONS: If surgery trends for OA continue, Australia faces an unsustainable joint replacement burden by 2030, with significant healthcare budget and health workforce implications. Strategies to reduce national obesity could produce important TKR savings.

Cooled radiofrequency ablation of the genicular nerves for chronic pain due to osteoarthritis of the knee: a cost-effectiveness analysis based on trial data.

BACKGROUND: For patients with painful knee osteoarthritis, long-term symptomatic relief may improve quality of life. Cooled radiofrequency ablation (CRFA) has demonstrated significant improvements in pain, physical function and health-related quality of life compared with conservative therapy with intra-articular steroid (IAS) injections. This study aimed to establish the cost-effectiveness of CRFA compared with IAS for managing moderate to severe osteoarthritis-related knee pain, from the US Medicare system perspective. METHODS: We conducted a cost-effectiveness analysis utilizing efficacy data (Oxford Knee Scores) from a randomized, crossover trial on CRFA (NCT02343003), which compared CRFA with IAS out to 6 and 12 months, and with IAS patients who subsequently crossed over to receive CRFA after 6 months. Outcomes included health benefits (quality-adjusted life-years [QALYs]), costs and cost-effectiveness (expressed as cost per QALY gained). QALYs were estimated by mapping Oxford Knee Scores to the EQ-5D generic utility measure using a validated algorithm. Secondary analyses explored differences in the settings of care and procedures used in-trial versus real-world clinical practice. RESULTS: CRFA resulted in an incremental QALY gain of 0.091 at an incremental cost of $1711, equating to a cost of US$18,773 per QALY gained over a 6-month time horizon versus IAS. Over a 12-month time horizon, the incremental QALY gain was 0.229 at the same incremental cost, equating to a cost of US$7462 per QALY gained versus IAS. Real-world cost assumptions resulted in modest increases in the cost per QALY gained to a maximum of US$21,166 and US$8296 at 6 and 12 months, respectively. Sensitivity analyses demonstrated that findings were robust to variations in efficacy and cost parameters. CONCLUSIONS: CRFA is a highly cost-effective treatment option for patients with osteoarthritis-related knee pain, compared with the US$100,000/QALY threshold typically used in the US.

Routine Patellar Resurfacing During Total Knee Arthroplasty Is Not Cost-Effective in Patients Without Patellar Arthritis.

BACKGROUND: Currently, the decision to resurface the patella is often made irrespective of the presence of patellar arthritis. The purpose of this study is to utilize the existing literature to assess cost-utility of routinely vs selectively resurfacing the patella. METHODS: Prospective randomized studies of patella resurfacing vs non-resurfacing in total knee arthroplasty (TKA) were identified through literature review. Data from these studies represented probabilities of varied outcomes following TKA dependent upon patella resurfacing. Using previously validated utility scores from the McKnee modified Health Utilities Index, endpoint utility values were provided for each potential outcome. RESULTS: Literature review yielded a total of 14 studies with 3,562 patients receiving 3,823 TKAs, of which 1,873 (49.0%) patellae were resurfaced. Persistent postoperative anterior knee pain occurred in 20.9% vs 13.2% (P < .001) and patella reoperation was performed in 3.7% vs 1.6% (P < .001) of unresurfaced and resurfaced patella, respectively. In studies excluding those with arthritic patellae, the incidence of anterior knee pain was equivalent between groups and reoperation decreased to 1.2% vs 0% (P = .06). Patella resurfacing provided marginally improved quality-adjusted life-years (QALY) for both selective and indiscriminate patella resurfacing. When including all studies, the incremental cost per QALY was $3,032. However, when analyzing only those studies with nonarthritic patellae, the incremental cost per QALY to resurface the patella increased to $183,584. CONCLUSION: Patellar resurfacing remains a controversial issue in TKA. Utilizing data from new prospective randomized studies, this analysis finds that routinely resurfacing arthritis-free patellae in TKA are not cost-effective.

Cost-effectiveness of generic celecoxib in knee osteoarthritis for average-risk patients: a model-based evaluation.

OBJECTIVE: The cost-effectiveness of the recently-introduced generic celecoxib in knee OA has not been examined. METHOD: We used the Osteoarthritis Policy (OAPol) Model, a validated computer simulation of knee OA, to evaluate long-term clinical outcomes, costs, and cost-effectiveness of generic celecoxib in persons with knee OA. We examined eight treatment strategies consisting of generic celecoxib, over-the-counter (OTC) naproxen, or prescription naproxen, with or without prescription or OTC proton-pump-inhibitors (PPIs) to reduce gastrointestinal (GI) toxicity. In the base case, we assumed that annual cost was $130 for OTC naproxen, $360 for prescription naproxen, and $880 for generic celecoxib. We considered a willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY) and discounted costs and benefits at 3% annually. In sensitivity analyses we varied celecoxib toxicity, discontinuation, cost, and pain level. RESULTS: In the base case analysis of the high pain cohort (WOMAC 50), celecoxib had an incremental cost-effectiveness ratio (ICER) of $284,630/QALY compared with OTC naproxen. Only under highly favorable cost, toxicity, and discontinuation assumptions (e.g., annual cost below $360, combined with a reduction in the cardiovascular (CV) event rates below baseline values) was celecoxib likely to be cost-effective. Celecoxib might also be cost-effective at an annual cost of $600 if CV toxicity were eliminated completely. In subjects with moderate pain (WOMAC 30), at the base case CV event rate of 0.2%, generic celecoxib was only cost-effective at the lowest plausible cost ($190). CONCLUSION: In knee OA patients with no comorbidities, generic celecoxib is not cost-effective at its current price.

Development and validation of a new population-based simulation model of osteoarthritis in New Zealand.

OBJECTIVE: To describe the construction and preliminary validation of a new population-based microsimulation model developed to analyse the health and economic burden and cost-effectiveness of treatments for knee osteoarthritis (OA) in New Zealand (NZ). METHOD: We developed the New Zealand Management of Osteoarthritis (NZ-MOA) model, a discrete-time state-transition microsimulation model of the natural history of radiographic knee OA. In this article, we report on the model structure, derivation of input data, validation of baseline model parameters against external data sources, and validation of model outputs by comparison of the predicted population health loss with previous estimates. RESULTS: The NZ-MOA model simulates both the structural progression of radiographic knee OA and the stochastic development of multiple disease symptoms. Input parameters were sourced from NZ population-based data where possible, and from international sources where NZ-specific data were not available. The predicted distributions of structural OA severity and health utility detriments associated with OA were externally validated against other sources of evidence, and uncertainty resulting from key input parameters was quantified. The resulting lifetime and current population health-loss burden was consistent with estimates of previous studies. CONCLUSION: The new NZ-MOA model provides reliable estimates of the health loss associated with knee OA in the NZ population. The model structure is suitable for analysis of the effects of a range of potential treatments, and will be used in future work to evaluate the cost-effectiveness of recommended interventions within the NZ healthcare system.