Abstract
BackgroundThe hyaluronic acid (HA) injections are widely used in knee osteoarthritis (OA) patients. We conducted the study comparing the efficacy and safety of single injection of Crosslinked Hyaluronic Acid Platform Hyaluronan (CHAP-HA) with 3-injection of linear hyaluronan in knee OA patients.MethodsThis was a randomized two-arms, evaluator-blinded, controlled, single-center study. Participants with knee OA received single CHAP-HA or three-injection of linear-HA. The 140 patients aged 35–85 years with radiographically confirmed knee OA were enrolled. At week 4, 12, 26, 39, and 52, visual analog scale (VAS) pain score, Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, timed up and go (TUG) and subject’s adverse events (AE) of these 2 groups were recorded. Primary outcome of the differences of VAS pain score at week 26 between groups was analyzed with analysis of covariance (ANCOVA). At week 52, those who met the inclusion criteria could receive a CHAP-HA injection and being followed-up for the adverse events for 4 weeks.ResultsThe trial was conducted from September 2015 to April 2017. A total 140 subjects were available for analysis (71 in the CHAP-HA group and 69 in the linear-HA group). At 26th week, there were significant more improvements in VAS pain scores in CHAP-HA compared with linear-HA. Both CHAP-HA and linear-HA showed significant improvements in the VAS pain score at week 26 compared with the baseline, and the occurrence of adverse events during the study period showed no between-group difference. In subjects with KL = 2, both groups showed significant improvements in VAS pain scores within 26 weeks. In patients with KL = 3, only CHAP-HA group showed significant improvement in VAS pain from 4 to 39 weeks. No unexpected or severe AEs were reported.ConclusionsA single injection of CHAP-HA may be safe and more effective for 26 weeks in patients with knee OA by comparing to linear-HA; moreover, the pain relief effect of CHAP-HA may remain until 52 weeks. For patients with more severe OA, CHAP-HA was demonstrated to be more preferable to relieve OA pain. Furthermore, repeat treatment of CHAP-HA or using CHAP-HA after a three-injection HA was proved to be safe.Trial registrationClinicalTrials.gov: NCT03643588. Date: August 23, 2018 (retrospectively registered).Level of Evidence: Therapeutic Level I.
Highlights
The hyaluronic acid (HA) injections are widely used in knee osteoarthritis (OA) patients
A single injection of Crosslinked Hyaluronic Acid Platform (CHAP)-HA may be safe and more effective for 26 weeks in patients with knee OA by comparing to linear-HA; the pain relief effect of Crosslinked Hyaluronic Acid Platform Hyaluronan (CHAP-HA) may remain until 52 weeks
Because patients were aware of their allocations, they were reminded by the blinded study coordinator prior to every visit that they should not inform the evaluator of their allocations
Summary
The hyaluronic acid (HA) injections are widely used in knee osteoarthritis (OA) patients. Osteoarthritis (OA) is a structural pathology of the joints It involves proteolysis starting from the edges of joints and cartilage, resulting in lesions, and a decrease in the level of proteoglycans. This pathological change causes cartilage softening and cartilage inflammation [1, 2]. Proteoglycans were found to polymerize with hyaluronic acid (HA) during normal cartilage metabolism but not in degenerated cartilage [3] Both in vivo and in vitro studies have shown that exogenous HA can induce the polymerization and synthesis of proteoglycans [4, 5], formation of endogenous HA [4], modulation of the inflammatory response [4, 6], reduction of the activity of inflammatory factors, and removal of reactive oxygen species [7]. HA injection is a major option for the treatment of OA pain
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