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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.
J Bone Joint Surg Am 2017; 99(6):462-471JB

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.

LEVEL OF EVIDENCE

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Authors+Show Affiliations

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.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28291178

Citation

Sun, Shu-Fen, et al. "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." The Journal of Bone and Joint Surgery. American Volume, vol. 99, no. 6, 2017, pp. 462-471.
Sun SF, Hsu CW, Lin HS, et al. 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. J Bone Joint Surg Am. 2017;99(6):462-471.
Sun, S. F., Hsu, C. W., Lin, H. S., Liou, I. H., Chen, Y. H., & Hung, C. L. (2017). 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. The Journal of Bone and Joint Surgery. American Volume, 99(6), pp. 462-471. doi:10.2106/JBJS.16.00469.
Sun SF, et al. 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. J Bone Joint Surg Am. 2017 Mar 15;99(6):462-471. PubMed PMID: 28291178.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Sun,Shu-Fen, AU - Hsu,Chien-Wei, AU - Lin,Huey-Shyan, AU - Liou,I-Hsiu, AU - Chen,Yin-Han, AU - Hung,Chia-Ling, PY - 2017/3/15/entrez PY - 2017/3/16/pubmed PY - 2017/4/19/medline SP - 462 EP - 471 JF - The Journal of bone and joint surgery. American volume JO - J Bone Joint Surg Am VL - 99 IS - 6 N2 - 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. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. SN - 1535-1386 UR - https://www.unboundmedicine.com/medline/citation/28291178/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_ L2 - http://dx.doi.org/10.2106/JBJS.16.00469 DB - PRIME DP - Unbound Medicine ER -