Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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.|
- Pain measured on a visual scale on movement (VAS-movement)
- At rest (VAS-rest)
- During the night (VAS-night)
- KOOS scores (knee injury and osteoarthritis outcome score)
- Daily consumption of analgetics
- Cartilage and bone degradation markers
- The quadriceps circumference (cm), ability to bend (degrees flexion) and stretch (degrees extension) the knee joint
- Global assessment patient
- Global assessment investigator
|Study Start Date:||May 1999|
|Estimated Study Completion Date:||November 2001|
|Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102|
|Copenhagen, Copenhagen Ø, Denmark, 2100|
|Principal Investigator:||Charlotte Lundsgaard, MD||Copenhagen Trial Unit (CTU)|