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Rivista di Medicina Fisica e Riabilitativa dopo Eventi Patologici
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European Journal of Physical and Rehabilitation Medicine 2011 Settembre;47(3):407-15
A prospective observational study of the clinical efficacy and safety of intra-articular sodium hyaluronate in synovial joints with osteoarthritis
Foti C. 1, Cisari C. 2, Carda S. 2, Giordan N. 3, Rocco A. 1, Frizziero A. 4, Della Bella G. 1
1 Physical and Rehabilitation Medicine Chair, Tor Vergata University, Rome, Italy;
2 Division of Physical and Rehabilitative Medicine, Amedeo Avogadro Piemonte Orientale University, Novara, Italy;
3 Fidia Farmaceutici, Clinical Research, Abano Terme, Padua, Italy;
4 Department of Anatomic Science and Musculo-skeletal Physiopathology, Movement Analysis Laboratory, Rizzoli Orthopedic Institute, Bologna University, Bologna, Italy
BACKGROUND:Clinical trials have demonstrated the safety and efficacy of hyaluronic acid-based products for the treatment of synovial joints affected by osteoarthritis (OA), but data from observational studies of normal medical practice are sparse.
AIM: This study investigated the safety and efficacy of intra-articular (IA) sodium hyaluronate (MW 1500-2000 KDa; Hyalubrix®) in the treatment of synovial joint OA.
DESIGN: This is prospective, and observational study.
SETTING: This study was carried out at 47 specialist centers for physiatrists, orthopedics and rheumatology in Italy; the enrolled population, 1266 outpatient, was predominantly female (66%, 840/1266), with a mean age of 66 years, and a mean weight of 74 kg.
POPULATION: The Participants with OA received IA injections of the study treatment (2 mL) once per week for 3 weeks. The knee was the joint most commonly affected by OA (right knee 802/1266 [63%]; left knee 598/1266 [47%]), and the longest median duration of disease occurred in the carpal joint (right carpal joint 40 months; left carpal joint 60 months).
METHODS: The primary endpoints were tolerability and details of usage of the IA sodium hyaluronate syringe device. Efficacy parameters included assessment of self-reported pain via the Visual Analogue Scale (VAS), and evaluation of motor function via the Health Assessment Questionnaire (HAQ). Quality of life (QoL) was assessed using the Euro QoL questionnaire (Clinical Trial Registration Number: ISRCTN 42690497).
RESULTS: Data from 1266 participants were collected. The adverse event (AE) rate was 0.8% (95% CI, 0.4 to 1.5). Thirteen AEs were reported, 12 of which were mild or moderate in severity. Only one participant discontinued study treatment following an AE. No serious adverse events occurred. Coadministration of local anesthetic was required by up to 10% of patients. Statistically significant improvements in VAS, HAQ and EuroQoL were recorded in multiple joints (P<0.0001 for each).
CONCLUSION: The study treatment was safe and well tolerated.
CLINICAL REHABILITATION IMPACT:. The study treatment reduced pain, improved mobility, and increased QoL in participants with OA.