title: Comparison of Single Intra-Articular Injection of Novel Hyaluronan (HYA-JOINT Plus) with Synvisc-One for Knee Osteoarthritis: A Randomized, Controlled, Double-Blind Trial of Efficacy and Safety.
abstract: BACKGROUND
  Viscosupplementation has been widely used for the treatment of knee osteoarthritis. Because we found no well-controlled trial comparing single-injection regimens of hyaluronan for knee osteoarthritis, we compared the efficacy and safety of a single intra-articular injection of a novel cross-linked hyaluronan (HYA-JOINT Plus) with a single injection of Synvisc-One in patients with knee osteoarthritis.
  
  
  METHODS
  In a prospective, randomized, controlled, double-blind trial with a 6-month follow-up, 132 patients with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) were randomized to receive 1 intra-articular injection of 3 mL of HYA-JOINT Plus (20 mg/mL) (n = 66) or 6 mL of Synvisc-One (8 mg/mL) (n = 66). The primary outcome was the change from baseline in the visual analog scale (VAS) (0 to 100 mm) pain score at 6 months. Secondary outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert scale), Lequesne index, timed "Up & Go" (TUG) test, single-limb stance (SLS) test, use of rescue analgesics, and patient satisfaction.
  
  
  RESULTS
  A total of 121 patients were available for the intention-to-treat analysis at 6 months. Both groups had a significant improvement in the VAS, WOMAC, and Lequesne index scores at each follow-up visit (p < 0.001). Patients who received HYA-JOINT Plus experienced a significantly greater improvement in the VAS pain score at 1, 3, and 6 months compared with those treated with Synvisc-One (adjusted mean difference: -12.0, -8.5, and -6.6; p = 0.001, 0.033, and 0.045, respectively). There were no significant between-group differences in any of the secondary outcomes except the WOMAC stiffness scores at 6 months, which favored HYA-JOINT Plus treatment (p = 0.043). The TUG time did not change significantly in either group during the study (p > 0.05), but the SLS time improved significantly in both the HYA-JOINT Plus and the Synvisc-One group (p = 0.004 and p = 0.022, respectively). No significant between-group differences were observed with respect to patient satisfaction or consumption of analgesics. No serious adverse events occurred following the injections.
  
  
  CONCLUSIONS
  A single injection of either HYA-JOINT Plus or Synvisc-One is safe and effective for 6 months in patients with knee osteoarthritis. HYA-JOINT Plus is superior to Synvisc-One in terms of reducing the VAS pain score at 1, 3, and 6 months and the WOMAC stiffness score at 6 months, with similar safety.
  
  
  METHODS
  Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
authors.affiliation: 1Department of Physical Medicine and Rehabilitation (S.-F.S., I-H.L., Y.-H.C., and C.-L.H.) and Department of Internal Medicine (C.-W.H.), Kaohsiung Veterans General Hospital, Kaohsiung City, Taiwan 2National Yang-Ming University School of Medicine, Taipei City, Taiwan 3School of Nursing, Fooyin University, Kaohsiung City, Taiwan.
authors.forename: Shu-Fen
authors.initials: SF
authors.lastname: Sun
authors.forename: Chien-Wei
authors.initials: CW
authors.lastname: Hsu
authors.forename: Huey-Shyan
authors.initials: HS
authors.lastname: Lin
authors.forename: I-Hsiu
authors.initials: IH
authors.lastname: Liou
authors.forename: Yin-Han
authors.initials: YH
authors.lastname: Chen
authors.forename: Chia-Ling
authors.initials: CL
authors.lastname: Hung
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010147:Pain Measurement; D017060:Patient Satisfaction; D016896:Treatment Outcome; D055675:Viscosupplements / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D055675:Viscosupplements; C049816:hylan; D006820:Hyaluronic Acid