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 and Wiroon Laupattarakasem
Department of Orthopedics, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40001, Thailand
- *Corresponding Author:
- Weerachai Kosuwon
Department of Orthopedics
Faculty of Medicine, Khon Kaen University
Khon Kaen, 40001, Thailand
E-mail: [email protected]
Received date: April 27, 2012; Accepted date: June 25, 2012; Published date: June 26, 2012
Citation: Kosuwon W, Sirichatiwapee W, Visanuyotin T, Jeeravipoolvarn P, Laupattarakasem W (2012) Determination of Cartilage Volume Using MRI in Patients with Knee Osteoarthritis: Efficacy Study of 25 Milligrams of Sodium Hyaluronate (2.5 Ml) Versus Placebo. Clin Exp Pharmacol 2:112. doi: 10.4172/2161-1459.1000112
Copyright: © 2012 Kosuwon W, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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<0.05). The mean difference in the total WOMAC score and all three subscales in the GoOn® vs. the placebo groups were statistically significant (p<0.05). The difference in mean VAS between both groups was not statistically significant. No adverse events were reported. Conclusion: GoOn® was an effective symptomatic treatment in mild to moderately painful OA knees according to the WOMAC score. In the short-term six-month period, there was not any change in the total cartilage volume except at the femoro-tibial junction.