The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis

Summary

To demonstrate the difference in terms of symptomatic efficacy between ADANT® sodium hyaluronate and placebo following an intra-articular injection in patients with symptomatic osteoarthritis of the hip. Each patient will receive an injection of sodium hyaluronate or placebo in the symptomatic hip and will be followed up for three months. At the third month, if the score for overall pain is still \> 40 mm on the VAS, a second injection of ADANT® can be given irrespective of which treatment was received previously. The patient will be followed up for a further 3 months in an open-label fashion (monthly visits).

Timeline

Start

2005-01

Primary completion

2007-03

Completion

2007-03

Outcome

Missed primary endpoint

paper mean +/- SD decrease 7.8 +/- 24.9 mm with HA versus 9.1 +/- 27.4 mm with placebo; P = 0.98 PMID 19248105 ↗

paper Our findings indicate that a single IA injection of HA is no more effective than placebo in treating the symptoms of hip OA. PMID 19248105 ↗

Publications

• Richette P, Ravaud P, Conrozier T, Euller-Ziegler L, Mazieres B, Maugars Y, Mulleman D, Clerson P, Chevalier X. Effect of hyaluronic acid in symptomatic hip osteoarthritis: a multicenter, randomized, placebo-controlled trial. Arthritis Rheum. 2009 Mar;60(3):824-30. doi: 10.1002/art.24301.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sodium Hyaluronate	Other / unclassified	2.5 ml	—

Indications