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Abstract
The objective of this 12-week, doublemasked, randomized, multicenter study was to
compare the elastoviscous properties of a high-molecular-weight viscosupplement, hylan
G-F 20 (polymer concentration, 0.8%), with those of a lower-molecularweight hyaluronan
(LMW HA) product (polymer concentration, 1%) and to determine the relationship of
elastoviscosity to efficacy in the treatment of patients with osteoarthritis (OA)
of the knee. Patients had radiographically confirmed primary idiopathic OA of the
knee (Larsen grades I to V) with pain despite other treatments. After a 2-week washout
period, 70 patients (73 knees) received three 2-mL intra-articular injections of test
solution at 1-week intervals. Thirty-eight patients (38 knees) received hylan G-F
20, and 32 patients (35 knees) received LMW HA. During the 12-week follow-up period,
the primary outcome measures assessed by patients (using a visual analogue scale)
were weight-bearing pain, most painful knee movement, and overall treatment response;
the primary outcome measures assessed by study evaluators were weight-bearing pain
and overall assessment of treatment. The dynamic elastoviscous properties of the test
solutions were measured on an oscillating Couettetype rheometer. Hylan G-F 20 was
more elastoviscous than the LMW HA at all frequencies measured (0.001 to 10 Hz). At
the final evaluation, patients who received hylan G-F 20 had significantly better
results on all primary outcome measures compared with those who received LMW HA. No
systemic adverse events were reported. Local adverse events consisted of pain or swelling,
noted in 2 of 38 knees injected with hylan G-F 20, and pain, noted in 1 of 35 knees
injected with LMW HA (adverse event rates per injection, 1.8% and 0.9%, respectively).
The difference in the incidence of adverse events between groups was not statistically
significant. The higher-molecular-weight, more elastoviscous hylan G-F 20 had significantly
greater pain-relieving effects than did the lower-molecular-weight, less elastoviscous
hyaluronan.
Key words
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Article info
Publication history
Accepted:
July 22,
1999
Identification
Copyright
© 1999 Published by Elsevier Inc.
