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Intra-articular hylastan versus steroid for knee osteoarthritis

  • Knee
  • Published:
Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

Abstract

Purpose

To assess the efficacy and safety of one and two intra-articular (IA) injections of the new viscosupplement, hylastan, compared with a single IA corticosteroid injection for pain due to knee osteoarthritis (OA). Hylastan is a high-molecular-weight hyaluronan derivative prepared from bacterial fermented sodium hyaluronate that was developed to remain in the joint for longer than most other viscosupplements.

Methods

This 6-month, double-blind, randomized, parallel group, multicenter trial enrolled patients aged ≥40 years who met American College of Rheumatology criteria for knee OA and had continued pain despite conservative treatment. Patients were randomized 1:1:1 to one of three arms: 2 × 4 mL hylastan (n = 129; arthrocentesis then IA hylastan Day 0, same treatment Week 2); 1 × 4 mL hylastan (n = 130; arthrocentesis then IA hylastan Day 0, arthrocentesis only Week 2); steroid (n = 132; arthrocentesis then IA methylprednisolone acetate 40 mg Day 0, arthrocentesis only Week 2). Participants and evaluators were blinded to treatment. The primary clinical outcome measure was change from baseline in WOMAC A pain score over all postbaseline visits to Week 26.

Results

Statistically significant pain reduction was observed in all three arms, with similar mean (95 % CI) changes in WOMAC A: 2 × 4 mL hylastan −0.9 (−1.0, −0.7); 1 × 4 mL hylastan −0.8 (−0.9, −0.7); steroid −0.9 (−1.0, −0.8); all P < 0.0001 versus baseline. Changes in secondary outcomes (OMERACT-OARSI and WOMAC A responder rates, patient/clinical observer global assessments, and WOMAC A1 walking pain) were similar in all three arms. Target knee adverse events were comparable for all treatments.

Conclusions

Both IA hylastan injection regimens were effective in relieving pain with an acceptable safety profile. IA hylastan did not show a difference versus IA corticosteroid; therefore, the hypothesis of superior pain relief was not met. Further research is needed to compare the efficacy and safety of hylastan with other viscosupplements.

Level of evidence

Therapeutic study, Level I.

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Acknowledgments

We thank the other participating investigators: Jeffrey Dugas M.D., Gregory D’Angelo M.D., Kathleen Weber M.D., Frederick Dietz M.D., Frank Smith M.D., David Fox M.D., Jon Zoltan M.D., James Yates M.D., James Van Horne M.D., George Morris M.D., Dr. Pieter Beks, Dr. Torsten Drescher, Dr. Christophe Baudot, Dr. Fraser Birrell. This study was funded by Genzyme Corporation, Cambridge, MA, USA. Medical writing assistance was provided by Helen Varley, Ph.D., UBC-Envision Group, Horsham, UK, which was supported by Genzyme Corp., Cambridge, MA, USA.

Conflict of interest

The institution of B.B. has received funding from Genzyme Corp. B.J.S. is a paid employee of Genzyme Corp.; C.E. and F.B. were paid employees of Genzyme Corp. at the time of the study and manuscript writing. The other authors declare that they have no conflict of interest.

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Correspondence to François Bailleul.

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Housman, L., Arden, N., Schnitzer, T.J. et al. Intra-articular hylastan versus steroid for knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc 22, 1684–1692 (2014). https://doi.org/10.1007/s00167-013-2438-7

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