To assess the effect of viscosupplementation with Hylan G-F 20 on the progression of cartilage loss over two years in patients with knee osteoarthritis (OA).
A single-blind, parallel control group pilot clinical trial was performed in 78 eligible patients with symptomatic knee OA (Kellgren Lawrence grade II and III). Patients were assigned to either an intervention group (n=39, receiving four courses (3 x 2.0cc) of intra-articular HYLAN-G-F 20injections at six months intervals or a control group (n=39, without injections but receiving usual care for OA). Magnetic resonance imaging the target knee was performed at baseline, 6, 12, and 24 months and images were analyzed blinded both to patient group and sequence Tibial cartilage volume, tibiofemoral cartilage defects and bone marrow lesions were assessed at baseline and follow up.
55 subjects (71%) completed 2-year follow up. There was no significant difference in age, gender, BMI, baseline cartilage volume, bone marrow lesions and bone area in those who completed and those who did not (all P>0.13). Analysis of completers demonstrated a significantly reduced annual percentage rate of medial, lateral and total tibial cartilage loss in the intervention group (mean±SD, −0.3±2.7%, −1.4±4.3% and −0.5±2.3%) compared with the control group (2.3±2.6%, 1.4±2.6%, 1.6±1.8%, P=0.001, 0.005 and 0.001 for difference, respectively). The intervention group also showed a significant reduction in the increase of cartilage defect score in the medial and total tibiofemoral compartments (0.1±1.3 and 0.5±2.0) compared with the control group (0.8±1.5 and 1.6±2.0, all P=0.05). There was no significant difference of change in bone marrow lesions between the intervention and control groups.
6 monthly intra-articular injections of HYLAN-G-F 20 administered without regard to symptoms have a beneficial effect on knee cartilage preservation as measured by both cartilage volume and cartilage defect score. Over two years, the control group continues to lose cartilage while there is no significant loss of cartilage in the HYLAN G-F treated group. HYLAN G-F 20 could be further evaluated in larger trials as a possible disease-modifying agent in patients with knee OA.
© 2010 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.