OBJECTIVESeveral studies on knee osteoarthritis suggest that the intra-articular administration of hyaluronic acid products may be a relevant option in the management of patients with persistent pain. The aim of this study is to report the data of efficacy of US-guided HyalOne®/Hyalubrix® 60 injections in a large population of patients with hip osteoarthritis, repeated at least 2 times per year for up to seven years.PATIENTS AND METHODSThis is a prospective, post-marketing, cohort study. Data were collected from the ANTIAGE registry. Values of Lequesne index, pain VAS, NSAIDs intake, global medical and patients assessments were evaluated every six months from the baseline to the end of the follow-up, seven years later. The inclusion criteria were: age ≥18 years, symptomatic hip osteoarthritis of at least 1-year duration, and up to 84 months of follow-up. All the patients received hyaluronic acid injections at least every six months, using ultrasound guidance to ensure accurate placement.RESULTS1022 patients were included in the study. The patients were categorized by age classes, gender, and body mass index (BMI). All the groups show a statistically significant reduction at all time points compared to baseline values of Lequesne index, pain VAS, NSAIDs intake, global medical and patients assessments. There are slight differences in the subgroups of overweighted, obese and over 70 years patients.CONCLUSIONSOur study supports the clinical efficacy and safety of HyalOne®/Hyalubrix®60 in patients affected by osteoarthritis. This is the first study, reporting on a large cohort of patients in different categories with a long follow-up on seven years. The data confirm the proper use of ultrasound-guided viscosupplementation (VS) as background therapy in the management of hip osteoarthritis.

2012-08-01·Clinical Rheumatology3区 · 医学

Total hip replacement rate in a cohort of patients affected by symptomatic hip osteoarthritis following intra-articular sodium hyaluronate (MW 1,500–2,000 kDa) ORTOBRIX study

3区 · 医学

Article

作者: Sandro Tormenta ; Oreste Moreschini ; Umberto Massafra ; Massimariano Bisignani ; Bruno Laganà ; Emanuele Bizzi ; Fabio Mariottini ; Alberto Migliore ; Daniele De Amicis ; Prisco Piscitelli ; Giandomenico Logroscino ; Michele Calderaro ; Antonino Bella

Hip osteoarthritis is very common and costly. The European League Against Rheumatology Committee agenda asks for research to investigate treatments able to slow down the progression of hip osteoarthritis (OA), to delay joint replacement, and to determine the comparative effectiveness and cost-effectiveness of non-surgical and surgical treatment modalities as well as criteria relating to the indications for and timing of total hip replacement (THR). After publishing the results of a randomized controlled trial and a cohort study on the efficacy of Intra-articular sodium hyaluronate (MW 1,500-2,000 kDa) on symptomatic hip OA, we performed this retrospective study in patients suffering from hip OA treated with ultrasound-guided intra-articular injections of HyalOne (Hyalubrix 60 Italian brand name) involving a group of THR expert orthopedic surgeons to appraise whether or not considered eligible for THR and the frequency and timing of THR. Six orthopedists, not routinely performing hip intra-articular injections, each independently assessed whether 176 patients suffering from hip OA and treated with ultrasound-guided intra-articular injections of sodium hyaluronate (MW 1,500-2,000 kDa) were candidates for THR according to the clinical data (age, body mass index, Pain Visual Analog Scale, Lequesne Algofunctional Index, global patient assessment, global physician assessment, nonsteroidal anti-inflammatory drug intake, and hip X-ray) collected at the first intra-articular sodium hyaluronate injection visit and provided as anonymous electronic data. At 24 months, 159 out of 76 (90 %) patients did not undergo to THR. At 48 months, 82 % (N = 144) of the study population treated with intra-articular hyaluronic acid avoided THR. In the group of 93 patients considered candidates for THR (that is, in which 4, 5, or 6 orthopedic surgeons agreed that the patient was a suitable candidate for THR), only 17 had undergone THR, with survival results of 82 % at 24 months. At 48 months, this percentage reduced to 66 % in this group. In the other groups of patients (in which respectively 3, 2, 1 or no surgeons were in agreement that the patient was a candidate for THR) arthroplasty is not recorded. Sodium hyaluronate (MW 1,500-2,000 kDa) given by ultrasound-guided injection seems to delay THR in the real context of actual overall management of symptomatic hip OA patients. Although further studies are necessary to confirm these data and to identify outcome predictors, hip viscosupplementation should be considered as conservative treatment to perform before proposing patients for THR.

2011-12-01·Archives of Orthopaedic and Trauma Surgery3区 · 医学

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

3区 · 医学

Article

作者: Germano, Valentina ; Migliore, Alberto ; Valentina, Germano ; Umberto, Massafra ; Alberto, Migliore ; Emanuele, Bizzi ; Piscitelli, Prisco ; Prisco, Piscitelli ; Massafra, Umberto ; Tormenta, Sandro ; Mauro, Granata ; Lagana, Bruno ; Bruno, Laganà ; Granata, Mauro ; Bizzi, Emanuele ; Sandro, Tormenta

INTRODUCTIONClinical 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.METHODSIn 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.RESULTSData 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.CONCLUSIONSThe 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.

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