Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

Summary

251 consecutive patients with knee arthrosis were randomized to one of three interventions: Four weekly injections of 2 ml isotonic saline (placebo), 2 ml sodium hyaluronate (hyaluronan) or 20 ml isotonic saline (excessive saline). They all suffered from clinically and radiologically verified arthrosis of the knee with daily pain that did not respond to treatment with analgetics. Results were evaluated at weeks 1,2,3,4,8,12,16 and 26. Biochemical markers for bone and cartilage degradation were measured in urine/blood.

Timeline

Start

1999-05

Primary completion

—

Completion

2001-11

Outcome

Missed primary endpoint

paper Intra-articular hyaluronate or distention with physiological saline did not significantly reduce pain compared with physiological saline placebo in patients with osteoarthritis of the knee. PMID 18415773 ↗

Publications

• Lundsgaard C, Dufour N, Fallentin E, Winkel P, Gluud C. Intra-articular sodium hyaluronate 2 mL versus physiological saline 20 mL versus physiological saline 2 mL for painful knee osteoarthritis: a randomized clinical trial. Scand J Rheumatol. 2008 Mar-Apr;37(2):142-50. doi: 10.1080/03009740701813103.

Drugs

Indications