Status:
UNKNOWN
Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis
Lead Sponsor:
Glostrup University Hospital, Copenhagen
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief 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 isot...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Age below 60
- Unconsciousness
- Psychosis
- Demens
- 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.
Key Trial Info
Start Date :
May 1 1999
Trial Type :
INTERVENTIONAL
End Date :
November 1 2001
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT00144820
Start Date
May 1 1999
End Date
November 1 2001
Last Update
September 5 2005
Active Locations (1)
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1
Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102
Copenhagen, Copenhagen Ø, Denmark, 2100