Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

Glostrup University Hospital, Copenhagen251 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

251

Conditions

Osteoarthritis, Knee

Interventions

Injection of Hyaluronan or SalineDRUG

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102

Copenhagen, Copenhagen Ø, Denmark

Outcomes

Primary Outcomes

Pain measured on a visual scale on movement (VAS-movement)

At rest (VAS-rest)

During the night (VAS-night)

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

Data from ClinicalTrials.gov

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