Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis - Article Degenerative Joint Disease; Osteoarthritis arthritis
Clinical Trial: Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis
This study is no longer recruiting patients.
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.
|Osteoarthritis, Knee || Drug: Injection of Hyaluronan or Saline ||Phase IV |
MedlinePlus related topics: Osteoarthritis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Secondary Outcomes: 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
Expected Total Enrollment: 251
Study start: May 1999; Study completion: March 2006
Last follow-up: November 2001; Data entry closure: November 2001
- Patients, men/women age > 60 years with clinical,
- Radiological and possible arthroscopical verified knee osteoarthritis.
- Knee pain on the day of examination scoring more than 20 mm on a visual analogue scale (VAS) at baseline.
- Age below 60
- Ingestion of drugs that may influence the results of the clinical examinations
- Inflammatory diseases of the joints
- Rheumatoid arthritis or other inflammatory arthritis as diagnosed by American College of Rheumatology criteria
- Contraindication to hyalgan treatment
- Previous intraarticular fracture of a knee joint
- Infection or skin disease located at the place of injection and invasive procedures done to the knee joint within previous two months inclusive intra-articular injections of steroids.
- Any other condition that might interfere with the efficacy assessment or completion of the trial.
Denmark, Copenhagen Ø
Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102, Copenhagen, Copenhagen Ø, 2100, Denmark
Charlotte Lundsgaard, MD, Principal Investigator, Copenhagen Trial Unit (CTU)
Last Updated: September 2, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00144820
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
ClinicalTrials.gov processed this record on 2005-09-13