Viscosupplementation in the management of ankle osteoarthritis: a review.

INTRODUCTION: Osteoarthritis (OA) is a disease of synovial joints and is the most common cause of chronic pain. Viscosupplementation (VS) with hyaluronic acid (HA) is largely used for knee osteoarthritis therapy but the evidence for its usefulness in ankle osteoarthritis is limited. The objective of this review is to assess the efficacy of viscosupplementation treatment of ankle osteoarthritis in the current literature. METHODS: The following databases were searched: Medline (period 2006-2008), Database of Abstract on Reviews and Effectiveness and Cochrane Database of Systematic Reviews. Reference lists of relevant articles were controlled for additional references. The search terms Review, Viscosupplementation (VS), Osteoarthritis (OA), Hyaluronic acid (HA), Hyaluronan, Sodium hyaluronate, Ankle OA, Ankle joint were used to identify all studies relating to the use of VS therapy for the ankle OA. Methodological quality of included studies was assessed by assigning level of evidence as previously defined by the Centre for Evidence Based Medicine (CEBM). RESULT: Seven articles concerning the efficacy of a total of 275 patients undergoing VS treatment for ankle OA were included. One European study, one Taiwanese study, one Italian study, one Turkish study and three American studies with level of evidence ranging from I to IV evaluated the following products: Hyalgan, Synvisc, Supartz, Adant. CONCLUSION: Viscosupplementation is used widely in knee OA and is included in the professional guidelines for treatment of the disease in this joint. The potential for treating osteoarthritis of the ankle joint by viscosupplementation has been suggested in the literature, however, no dosing studies have been published to date, and dosing in the ankle joint remains an area for discussion. Viscosupplementation could potentially provide an useful alternative in treating such patients with painful ankle OA.

Intra-articular injection of hyaluronic acid (MW 1,500-2,000 kDa; HyalOne) in symptomatic osteoarthritis of the hip: a prospective cohort study.

INTRODUCTION: Clinical trials have demonstrated the safety and efficacy of hyaluronic acid-based products for the treatment of hip osteoarthritis, but data from observational studies of normal medical practice are scarce. This study investigated the long-term efficacy and tolerability of ultrasound-guided intra-articular sodium hyaluronate (MW 1,500-2,000 kDa; Hyalone) injections in daily clinical practice. METHODS: In this observational, cohort study of patients with hip osteoarthritis, Hyalone was administered under the ultrasound guidance, every 6 months, with the possibility of an additional injection at the intervening 3-month intervals on clinical request. Efficacy measurements included the Lequesne algofunctional index, self-reported pain via the visual analogue scale (VAS), the concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) and safety. The patients were followed up for 18 months after the first intra-articular injection. RESULTS: Data from 120 patients were collected. During the study, a statistically significant reduction in algofunctional indexes was demonstrated at 3 months after study product injection, while at 12 months 80% of the patients achieved a decrease of at least 30% in symptoms. These results were maintained over time through cyclical and personalized repetition of ultrasound guided injections, at least one injection every 6 months. CONCLUSIONS: The study treatment reduced pain and improved mobility in osteoarthritis of the hip. These results in daily clinical practice demonstrate a beneficial effect and the safety of the study product and suggest adding intra-articular injections of HyalOne to the armamentarium of conservative management of symptomatic hip osteoarthritis.

Pharmaco-economic issues in the treatment of severe osteoporosis.

INTRODUCTION: clinical guidelines recommend to identify and treat people at high risk of fracture. METHODS: we have carried out a simulation concerning pharmaco-economic issues in the treatment of severe osteoporosis and particularly those people with previous femoral fragility fractures, assuming that only 13.1% of hip fractured patients had started a proper antifracture therapy, as shown by the analysis of the Tuscany regional database. RESULTS: Annual costs sustained by the Italian healthcare system for treating hip fractured patients all over Italy have been estimated to range from 2 560 000 in year 2000 to 3 291 750 in year 2005, representing only 0,3% of the overall costs sustained because of hip fractures in Italy. CONCLUSIONS: Sixty percent of the pharmacological costs can be considered as ineffective from a therapeutic point of view because patients were assuming their drugs only for 6 months. There is a need for specific codification of osteoporotic fragility fractures at hospital admissions and for implementing regional strategies aimed to reduce hip re-fractures by increasing the number of patients on treatment and incrementing adherence to treatment.

The symptomatic effects of intra-articular administration of hylan G-F 20 on osteoarthritis of the hip: clinical data of 6 months follow-up.

Hip osteoarthritis (OA) is usually managed with systemic treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs) and/or symptomatic slow-acting drugs. Unfortunately, many patients either cannot tolerate NSAIDs or suffer serious, even fatal, NSAID-induced side effects, predominantly gastrointestinal ulceration and bleeding. Viscosupplementation, which aims to restore physiological and rheological features of the synovial fluid, is a well-accepted therapeutic option in knee OA patients, but limited data exist in the literature about its potential benefit for the treatment of hip OA. The purpose of this study is to observe the effects of hylan G-F 20 administered through ultrasound (US)-guided intra-articular (IA) injections in patients with symptomatic hip OA. We treated 30 patients with symptomatic hip OA. Under US guidance, 7 patients received one injection, 21 patients had two injections, and 2 patients received three injections, each with 2 ml of hylan G-F 20. Lequesne index, VAS scale of hip pain, and NSAID consumption were evaluated at baseline as well as 2 and 6 months after the beginning of the treatment. No systemic adverse events were observed. Lequesne index, VAS pain score, and NSAID consumption showed a reduction that was statistically significant to the baseline. The present observation suggests the potentiality for the safety and efficacy of hylan G-F 20 injected under US guidance in patients with symptomatic hip OA. Further controlled studies are needed.

[18-month observational study on efficacy of intraarticular hyaluronic acid (Hylan G-F 20) injections under ultrasound guidance in hip osteoarthritis]. / Studio osservazionale sull'efficacia a 18 mesi di iniezioni intraarticolari di acido ialuronico (Hylan G-F 20) sotto guida ecografica nell'artrosi dell'anca.

OBJECTIVE: To evaluate the efficacy and the tolerability of viscosupplementation (VS) with hyaluronic acid (Hylan GF 20) in a cohort of 36 patients affected by hip osteoarthritis through a 18 months follow-up. METHODS: Viscosupplementation was performed with an anteriorsagittal approach, under ultrasound guidance. 36 patients were administered hyaluronic acid intraarticularly in the hip, with a unique injection of Hylan G-F20, which could be repeated after at least 3 months. Treatment efficacy was assessed by functional index WOMAC, pain evaluation on a visual analogue scale and NSAID consumption. All such parameters were recorded at the time of the first injection and then 3, 6, 9, 12 and 18 months later. RESULTS: Statistically significant reduction of all parameters was observed three months after the injection, and was still maintained at the timepoints 6, 9, 12 and 18 months. No local side effects have been observed, nor systemic complications. CONCLUSIONS: Our data show that viscosupplementation is a promising approach for hip osteoarthritis, providing beneficial effects in a long-term follow up. Yet, the topic deserves further and wider studies, so to define the number of injections to administer and suggest a fit interval between subsequent injections.

Open pilot study of ultrasound-guided intra-articular injection of hylan G-F 20 (Synvisc) in the treatment of symptomatic hip osteoarthritis.

Patients suffering from hip osteoarthritis (OA) are frequently symptomatic, and the disease can result in significant limitation of patients' activity and high social costs. Hip OA is generally managed with systemic treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs) and/or symptomatic slow acting drugs. Viscosupplementation with hyaluronan (HA) or its derivatives, which aims to restore the physiological and rheological features of the synovial fluid to improve symptoms, is now a routinely prescribed treatment for OA of the knee. However, few data exist in the literature regarding the use of viscosupplementation in the treatment of hip OA. The objective of this prospective, open, uncontrolled pilot study was to investigate the safety and effectiveness of intra-articular injection, under ultrasound control, of hylan G-F 20 for the treatment of OA of the hip. Twelve patients (> or =40 years old) with symptomatic hip OA were treated with one injection of 2 ml of hylan G-F 20 under ultrasound guidance. During the study, patients were evaluated for safety and efficacy using the Lequesne index, a visual analogue scale (VAS) measure of hip OA pain and analysis of NSAID consumption. Patients treated with hylan G-F 20 in this study showed clinically significant reductions in Lequesne and VAS scores and in the consumption of NSAIDs up to 3 months after the injection. In the 12 patients treated (total of 14 injections), no systemic adverse events were observed. Three patients reported mild, local pain post-injection. This study demonstrates the potential of ultrasound-guided intra-articular injections of a viscosupplement into the hip joint and gives positive preliminary information about the safety and efficacy of hylan G-F 20 for the treatment of symptomatic hip OA.

Incidence and costs of hip fractures vs strokes and acute myocardial infarction in Italy: comparative analysis based on national hospitalization records.

OBJECTIVES: As osteoporotic fractures are becoming a major health care problem in countries characterized by an increasing number of older adults, in this study we aimed to compare the incidence and costs of hip fragility fractures in Italian elderly people versus those of major cardiovascular diseases (strokes and acute myocardial infarctions [AMI]) occurring in the whole adult population. METHODS: We analyzed hospitalization records maintained at the national level by the Italian Ministry of Health for the diagnosis of hip fractures (ICD-9-CM codes 820-821), AMI (code 410), hemorrhagic (codes 430, 431, 432) and ischemic strokes (codes 433-434), and TIA (code 435) between 2001-2005. Cost analyses were based on diagnosis-related groups. RESULTS: The incidence of hip fractures in elderly people has increased (+12.9% between 2001 and 2005), as well as that of AMI (+20.2%) and strokes (hemorrhagic: +9.6%; ischemic: +14.7) occurring in the whole adult population; conversely, hospitalization due to TIA decreased by a rate of 13.6% between 2001 and 2005. In 2005, the hospital costs across the national health care system that were associated with hip fragility fractures in the elderly were comparable to those of strokes (both hemorrhagic and ischemic), which occurred in the whole Italian adult population. Moreover, these costs were higher than those generated by AMI and TIA. Rehabilitation costs following strokes reached about 3 billion Euros in 2005, but rehabilitative costs of hip fractures and AMI were comparable (about 530 million Euros in 2005). CONCLUSION: The burden of hip fragility fractures in Italy is comparable to that of AMI and strokes.

The occurrence of acute myocardial infarction in Italy: a five-year analysis of hospital discharge records.

BACKGROUND: The incidence and costs of acute myocardial infarction (AMI) in Europe represent a substantial problem due to population aging. METHODS: Between 2001 and 2005, Italian hospitalization records were examined to evaluate hospital admissions and costs of AMI in adults aged ≥ 45 and in elderly people ≥ 65 or ≥ 75. Hospital costs were calculated on the basis of Diagnosis Related Groups (DRGs). RESULTS: 75,586 men and 43,164 women were hospitalized because of AMI in 2005, showing respectively increases of 17.2% and 29.2% across five years. In the youngest age group (45-64), 29,925 hospitalizations in men and 6443 in women due to AMI were registered during 2005. In the subgroup of patients aged 65-74, 21,621 men and 10,145 women were hospitalized for AMI; in the oldest group (≥ 75) 24,040 and 26,576 hospitalizations were recorded. The increasing rates across the five examined years were 8.3% and 22.0% in the first age group, 14.3% and 17.4% in people aged 65-74, and 31.8% and 36.3% in the oldest subgroup, respectively in men and women. Among AMI patients aged ≥ 75, the number of women was always higher than that of men. Overall hospitalization costs due to AMI in Italy were 305 million Euros in 2001 and 370 million in 2005, with an average cost of 3115 Euros per patient in the latter year. CONCLUSION: Our findings confirm AMI as a leading health problem and a leading cause of health care costs.

Comparative, double-blind, controlled study of intra-articular hyaluronic acid (Hyalubrix) injections versus local anesthetic in osteoarthritis of the hip.

INTRODUCTION: Comparison of intra-articular bacterial-derived hyaluronic acid (Hyalubrix) (HA) with local analgesia (mepivacaine) for osteoarthritis (OA) of the hip. METHODS: A pilot prospective, double-blind, 6-month randomized trial of 42 patients with hip OA. HA or mepivacaine was administered twice (once a month) under ultrasound guidance. Efficacy measurements included the Lequesne's algofunctional index, a visual analog scale for pain, concomitant use of analgesia, patient and physician global measurement, and safety. RESULTS: Patients in the HA group exhibited a significantly reduced Lequesne's algofunctional index 3 and 6 months after treatment (P < 0.001) and significantly reduced visual analog scale pain scores 3 and 6 months after treatment (P < 0.05) compared with the local anesthetic group. All primary and secondary measures were significantly improved versus baseline, but other than the above were not different from each other at 3 or 6 months. Adverse effects were minimal. CONCLUSIONS: This comparative study suggests a beneficial effect and safety of intra-articular HA in the management of hip OA. TRIAL REGISTRATION NUMBER: ISRCTN39397064.

Intra-articular use of hyaluronic acid in the treatment of osteoarthritis.

Osteoarthritis is one of the leading causes of disability in the elderly. The changes in the lubricating properties of synovial fluid lead to significant pain and loss of function. More than ten years have passed from the first studies. Up till now many authors have supported intra-articular hyaluronan (HA) therapy as not only a symptom-modifying therapy but also a treatment which may significantly decrease the rate of deterioration of joint structure. In this review we report data relative to knee and hip treatment. The ongoing studies continue to further our understanding of the fundamental mechanisms that likely underlie the therapeutic benefits of this treatment but, despite recent progress, many unresolved issues require further study. Large scale double blind controlled studies must be carried out to confirm these promising data and produce meaningful guidelines.

Intra-articular administration of hylan G-F 20 in patients with symptomatic hip osteoarthritis: tolerability and effectiveness in a large cohort study in clinical practice.

OBJECTIVE: This prospective, observational, open study aimed to assess the efficacy and safety of hylan G-F 20 in a large cohort of patients with symptomatic hip osteoarthritis (OA), and identify predictors of clinical response. RESEARCH DESIGN AND METHODS: Patients presenting with symptomatic hip OA received one 2 mL intra-articular (IA) injection of hylan G-F 20 under ultrasound guidance. Patients were followed-up every 3 months for a total of 12 months and were offered an optional, additional injection at each follow-up visit if symptomatically justified. At each visit, pain scores (100 mm visual analogue scale [VAS]), Lequesne index scores, NSAID intake, and physician and patient global assessments scores were recorded. Adverse events (AEs) were recorded throughout the study. MAIN OUTCOME MEASURES; RESULTS: 250 patients completed the 12 month follow-up and received a total of 734 injections. Statistically significant reductions in VAS pain scores, Lequesne index scores and NSAID usage were reported at all time-points (p < 0.05). No systemic, serious or severe side effects were observed. Fifty-two local AEs were reported (7.08% per injection) all of which were mild and transient. One predictor of clinical response was identified, with patients < 75 years of age reporting better outcomes. CONCLUSIONS: This study supports the safety, tolerability and effectiveness of hylan G-F 20 in the treatment of symptomatic hip OA. Hylan G-F 20 may also offer economic benefits due to a reduction in NSAID usage and the resultant reduction in management costs of NSAID related side-effects. These data reflect those obtained in previous studies of hylan G-F 20 in patients with knee OA.