Intra-articular injection of non-animal stabilised hyaluronic acid (NASHA) for osteoarthritis of the hip: a pilot study

Clin Exp Rheumatol. May-Jun 2004;22(3):300-6.

Abstract

Objectives: This study was undertaken to assess the safety and potential efficacy of intra-articular non-animal stabilised hyaluronic acid (NASHA) in patients with hip OA.

Methods: This was a prospective, open-label, 3-month pilot study of a single intra-articular injection of NASHA in 31 patients. Safety outcomes were measured at 2 weeks and 3 months after treatment, as were efficacy measurements including WOMAC pain, stiffness and physical function scores, and the patient assessment of global disease status. Patients demonstrating reduced pain at month 3 participated in an extension phase (assessment at 6-11 months, 18 patients). Positive response was defined as a > or = 40% reduction in the WOMAC pain score from baseline, together with an absolute decrease of > or = 5 points.

Results: Intra-articular injection of NASHA into the hip was well tolerated. The only treatment-related AE was exacerbation of pain and/or stiffness in the treated hip (reported by 9 patients) and there were no serious AEs. The response rate to treatment was 50% at 2 weeks and 54% at 3 months. In the extension population, response rates of 69% and 44% were observed at month 3 and the extension visit, respectively. Global disease status was improved at month 3 compared with baseline in 68% of the patients.

Conclusions: Our results show that a single intra-articular injection of NASHA is a well tolerated and potentially effective therapy in the treatment of hip OA. Further studies of NASHA in this setting are warranted.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Adjuvants, Immunologic / therapeutic use*
  • Adult
  • Aged
  • Aged, 80 and over
  • Female
  • Health Status
  • Humans
  • Hyaluronic Acid / administration & dosage
  • Hyaluronic Acid / therapeutic use*
  • Injections, Intra-Articular
  • Male
  • Middle Aged
  • Osteoarthritis, Hip / drug therapy*
  • Osteoarthritis, Hip / physiopathology
  • Pilot Projects
  • Prospective Studies
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Adjuvants, Immunologic
  • Hyaluronic Acid