This trial is active, not recruiting.

Condition osteoarthritis, knee
Treatment injection of hyaluronan or saline
Phase phase 4
Sponsor Glostrup University Hospital, Copenhagen
Start date May 1999
End date November 2001
Trial size 251 participants
Trial identifier NCT00144820, KA 99005gs


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Pain measured on a visual scale on movement (VAS-movement)
time frame:
At rest (VAS-rest)
time frame:
During the night (VAS-night)
time frame:

Secondary Outcomes

KOOS scores (knee injury and osteoarthritis outcome score)
time frame:
Daily consumption of analgetics
time frame:
Cartilage and bone degradation markers
time frame:
The quadriceps circumference (cm), ability to bend (degrees flexion) and stretch (degrees extension) the knee joint
time frame:
Global assessment patient
time frame:
Global assessment investigator
time frame:

Eligibility Criteria

Male or female participants at least 60 years old.

Inclusion Criteria: - 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 Criteria: - 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.

Additional Information

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.
Principal investigator Charlotte Lundsgaard, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by Glostrup University Hospital, Copenhagen.