NCT00144820

Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

Intra-Articular Injections of Hyaluronan Versus 20 Ml NaCl Versus Placebo in Treatment of Knee Osteoarthritis: a Randomised, Double-Blind, Placebo Controlled Single Centre Trial.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 251 (planned)
• Sponsor: Glostrup University Hospital, Copenhagen · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Injection of Hyaluronan or Saline

Timeline

• Start date: 1999-05-01
• Completion: 2001-11-01
• First posted: 2005-09-05
• Last updated: 2005-09-05

Locations

1 site across 1 country: Denmark