Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

Glostrup University Hospital, Copenhagen

Status and phase

Unknown

Phase 4

Conditions

Osteoarthritis, Knee

Treatments

Drug: Injection of Hyaluronan or Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT00144820

KA 99005gs

Details and patient eligibility

About

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.

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.