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A single injection of
cross-linked hyaluronate should be considered over three weekly injections of
linear sodium hyaluronate due to its considerable safety and effectiveness in
reducing weight bearing pain in OA patients.
Knee osteoarthritis (OA) is one of the major causes of disability throughout the world. OA was designated as the fourth leading cause of years lived with disability at global level reporting for 3.0% of total global years lived with disability (YLDs) in 2000 according to the World Health Report. The loss of hyaluronan in the synovial fluid and cartilage of the knee cause joint pain and stiffness in knee OA patients.
HA CW et al. executed a randomized,
multi-center, double-blind, non-inferiority study to investigate the efficacy and safety of a cross-linked hyaluronate
(XLHA, single injection form) distinguished with a linear high molecular
hyaluronate (HMWHA, thrice injection form) in symptomatic knee osteoarthritis
patients.
A total of 287 patients with osteoarthritis (Kellgren-Lawrence grade I to III) were randomized
to each group. To maintain double-blindeness, three weekly injections were
given in both groups but two times of saline injections preceded the XLHA
injection. Twelve weeks after last injection, the primary endpoint revealed the
change of weight-bearing pain (WBP). As per the secondary outcomes, Western
Ontario and McMaster Universities Osteoarthritis index; pain at rest, at night,
or in motion; OMERACT-OARSI responder rate; proportion of patients attaining at
least 20 mm or 40% reduction in WBP; and rate of rescue medicine use and
its total consumption were considered.
Non-inferiority of XLHA to
HMWHA as the lower bound of 95% CI (-1.9 mm, 10.1 mm) was well above
the predefined margin (-10 mm) as the mean changes of WBP at 12 weeks
after the final injection was -33.3 mm and -29.2 mm with XLHA and HMWHA.
No significant between-group differences were observed in all the secondary
endpoints. The most common adverse event was pain at the injection site and
with no major safety concerns.
These findings revealed that the single cross-linked hyaluronate
injection was non-inferior to three injections of linear high molecular
hyaluronate with respect to WBP reduction. Hence, XLHA is an effective and safe
treatment for knee osteoarthritis.
BMC Musculoskelet Disord. 2017 May 26;18(1):223
Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study
Ha CW et al.
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