Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis - Full Text View

Sponsor:	Glostrup University Hospital,Copenhagen
Information provided by:	Glostrup University Hospital,Copenhagen
ClinicalTrials.gov Identifier:	NCT00144820

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis, Knee	Drug: Injection of Hyaluronan or Saline	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Joint Disorders Osteoarthritis

Drug Information available for: Hyaluronic acid Hyaluronate Sodium

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital,Copenhagen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	251
Study Start Date:	May 1999
Estimated Study Completion Date:	November 2001

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144820

Locations

Denmark, Copenhagen Ø
Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102
Copenhagen, Copenhagen Ø, Denmark, 2100

Sponsors and Collaborators

Glostrup University Hospital,Copenhagen

Investigators

Principal Investigator:

Charlotte Lundsgaard, MD

Copenhagen Trial Unit (CTU)

More Information

No publications provided by Glostrup University Hospital,Copenhagen

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lundsgaard C, Dufour N, Fallentin E, Winkel P, Gluud C. Intra-articular sodium hyaluronate 2 mL versus physiological saline 20 mL versus physiological saline 2 mL for painful knee osteoarthritis: a randomized clinical trial. Scand J Rheumatol. 2008 Mar-Apr;37(2):142-50.

Study ID Numbers:	KA 99005gs
Study First Received:	September 2, 2005
Last Updated:	September 2, 2005
ClinicalTrials.gov Identifier:	NCT00144820 History of Changes
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Glostrup University Hospital,Copenhagen:

Hyaluronan
Gonarthrosis
Osteoarthritis,knee

Double-blinded
Placebo controlled
Randomised

Additional relevant MeSH terms:

Osteoarthritis, Knee
Immunologic Factors
Musculoskeletal Diseases
Hyaluronic Acid
Osteoarthritis
Joint Diseases

Arthritis
Physiological Effects of Drugs
Adjuvants, Immunologic
Rheumatic Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009