Preliminary Evaluation of Potential Disease Modification by Hylan G-F 20 (Synvisc®) Using dGEMRIC

Abstract

The objective of the present study was to utilize delayed Gadolinium Enhanced MRI of Cartilage (dGEMRIC), as a reflection of cartilage matrix integrity, to evaluate the effects of a specific hyaluronan, hylan G-F 20 (SYNVISC ® ; Genzyme Biosurgery, Cambridge, MA) in OA patients over the course of 6 months, and to utilize these data to determine effect size and power calculations for future studies. An open-label, single-blind exploratory study of patients having knee OA (Trail registration: NCT00949494) was performed in thirty subjects (20 active, intra-articular injections (3, week apart) with hylan G-F 20; 10 control). dGEMRIC data was obtained at baseline, 3 and 6 months. No changes were measurable with hylan administration under the clinical and imaging conditions utilized in the current study. The lack of response in the current study may be because the subjects had a relatively advanced stage of disease with respect to cartilage integrity.

Delayed Gadolinium-Enhanced MRI of Cartilage (dGEMRIC) Shows No Change in Cartilage Structural Composition after Viscosupplementation in Patients with Early-Stage Knee Osteoarthritis

“…Such studies have already been performed and have shown a clinical improvement of HA injections compared to placebo [6,7]. Moreover, OA is generally a slow progressing disease in which no significant change in dGEMRIC outcomes was found at 14, 24 and 48 weeks follow-up compared to baseline in the control groups (n=15 and n=10 respectively) of two randomized controlled trials consisting of mild to moderate knee OA patients [25,26]. Thus, the absence of a control group was not considered a limitation to address our study aim, i.e.…”