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.
Highlights
The prevalence of osteoarthritis (OA) is increasing, and it is estimated by 2030 there will about 67 million Americans affected by this disease resulting in a substantial financial burden to society [1]
Radiographic analysis of joint space width (JSW) is the currently accepted marker for evaluating articular cartilage thickness, and changes in JSW over time have been defined for control and OA populations and used as endpoints in trials of potential therapeutic agents [5]
Neither of these approaches directly addresses changes that are known to occur in cartilage matrix and that are central to the OA process, namely loss of integrity of collagen fibers and the decrease in proteoglycan concentration [8]
Summary
The prevalence of osteoarthritis (OA) is increasing, and it is estimated by 2030 there will about 67 million Americans affected by this disease resulting in a substantial financial burden to society [1]. Non-surgical options include life style modifications, physical therapy, systemic anti-inflammatory medicines, intra-articular injections of steroids, and hyaluronic acid (HA) viscosupplementation While all these are in general considered to be directed toward symptom modification, there is some speculation as to the potential disease modification afforded by viscosupplementation [2,3]. MR imaging, which provides a measure of cartilage volume, has been proposed as a viable alternative to radiography [6], but not found to provide additional sensitivity to simple radiographic analysis [7] Neither of these approaches directly addresses changes that are known to occur in cartilage matrix and that are central to the OA process, namely loss of integrity of collagen fibers and the decrease in proteoglycan concentration [8]. Delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) is a technique that has been shown to be sensitive to such changes
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