Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00144820
• Other study ID #: KA 99005gs
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 2, 2005
• Last updated: September 2, 2005
• Start date: May 1999
• Est. completion date: November 2001

Study information

• Verified date: August 2005
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 251
• Est. completion date: November 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Injection of Hyaluronan or Saline

Locations

Country	Name	City	State
Denmark	Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102	Copenhagen	Copenhagen Ø

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measured on a visual scale on movement (VAS-movement)
Primary	At rest (VAS-rest)
Primary	During the night (VAS-night)
Secondary	KOOS scores (knee injury and osteoarthritis outcome score)
Secondary	Daily consumption of analgetics
Secondary	Cartilage and bone degradation markers
Secondary	The quadriceps circumference (cm), ability to bend (degrees flexion) and stretch (degrees extension) the knee joint
Secondary	Global assessment patient
Secondary	Global assessment investigator