Journal of Clinical & Experimental Pharmacology

Abstract

Determination of Cartilage Volume Using MRI in Patients with Knee Osteoarthritis: Efficacy Study of 25 Milligrams of Sodium Hyaluronate (2.5 Ml) Versus Placebo

Weerachai Kosuwon *,Winai Sirichatiwapee ,Tweechock Visanuyotin ,Polasak Jeeravipoolvarn ,Wiroon Laupattarakasem

Background: Osteoarthritis (OA) of the knee is prevalent and associated with both pain and functional disability. Visco-supplementation is an intra-articular therapeutic modality for the treatment of knee OA, based on the physiologic importance of hyaluronan in synovial joints. The therapeutic goal is to restore the viscoelasticity of synovial hyaluronan, decrease pain, improve mobility and restore the natural protective functions of hyaluronan in the joint radiography is currently the most widely used modality for assessing damage in OA: this technique allows the measurement of joint space width (JSW) the appropriate primary endpoint for demonstration of efficacy. There are, however, questions regarding its validity and reliability. Magnetic resonance imaging (MRI) with its superior soft tissue contrast is the best technique available for assessment of normal articular cartilage and cartilage volume. Therefore, this study aimed to evaluate the short-term benefit of intra-articular injection of hyaluronic acid (GoOn®) for protecting the articular by using MRI in patient with OA knee. Patients and Methods: This was a phase III double-blinded (i.e., both the patients and MRI examiners), randomized, controlled trial of 60 patients with mild to moderate knee OA, diagnosed according to both clinical signs and X-ray. All of the patients received MRIs (1.5 T) of the affected knee(s) at visit 0 and 6 months after the first injection. The patients received either an intra-articular injection into the affected knee weekly for 5 weeks of HA (GoOn®) or a placebo. Blinded examiners used the visual analog scale (VAS) and the WOMAC score to do weekly and monthly assessments for 6 months. The engineer used Mimics 10.01 to transform the MRI scanner data into 3D images of the articular cartilage for measuring CV, which was also blinded to the treatments. Results: Subjects averaged 59.5 years of age (range, 46 to 84). During the enrollment phase, only female farmers attended came. Four patients in the placebo group and one in the GoOn® group refused to undergo the second MRI. The mean body weight and height was 64.20 ± 10.25 kg and 1.53 ± 0.057 m, respectively. The respective baseline VAS and WOMAC score was 6.40 ± 1.64 and 51.65 ± 13.3. Forty-four patients were KL grade 2 and 16 were grade 3. The mean total CV at baseline in the GoOn® and placebo groups was 14.7 ± 3.5 ml and 15.5 ± 3.9 ml, respectively. There was no significant difference in the mean total CV after 6 months in either group (p>0.05) except at the femorotibial junction of the GoOn® group was increase CV more than the placebo group (p