Abstract

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE THE SAFETY AND EFFICACY PARAMETER OF INTRA ARTICULAR SODIUM HYALURONATE IN SYNOVIAL JOINTS WITH OSETOARTHRITIS

J. E. Rachel Nivedita* and H. Padmalatha

ABSTRACT

Clinical trials have demonstrated the safety and efficacy of hyaluronaic acid-based products for the treatment of synovial joints affected by osteoarthritis (OA), but data from observational studies of normal medical practice are sparse. This study investigated the safety and efficacy of intra-articular (IA) sodium hyaluronate. Hyaluronate in the treatment of synovial joints OA. This is prospective and observational study. This study was carried out at specialist centers for physiatrists, orthopedics and rheumatology. The enrolled population, out patients. The participants with OA received IA injections of the study treatment (2ml) once per week for 3 weeks. The knee was the joints most commonaly affected by OA, left knee and the longest median duration of disease occurred in the carpal joint (right carpal joins 40months; left carpal joints 60 months). The primary end points were tolerability and details of usage of the IA sodium hyaluronate syringe device. Efficacy parameter included assessments of self- reported pain via the visual analogue sacle (VAS), and evaluation of motor function via the health assessment questionnaire (HAQ). Quality of life (QoL) was assessed using the Euro QoL questionnaire. Data from participants were collected. AEs were reported, which were mild or moderate in severity. Only one participants discontinued study treatment following an AE. No serious adverse events occurred. Co administration of local anesthetic was required by upto 10% of patients. Statistically siginificant improvements in VAS, HAQ and EuroQoL were recorded in multiple joints (P<0.0001 for each). The study treatment was safe and well tolerated. The study treatment reduced pain, improved mobility, and increased QoL in participants with OA.

Keywords: clinical trials, Sodium Hyaluronate, Rheumatology, orthopedics.