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Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

This study is ongoing, but not recruiting participants.

Sponsored by: 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

MedlinePlus related topics:   Joint Disorders    Osteoarthritis   

ChemIDplus related topics:   Sodium chloride    Hyaluronate Sodium    Hyaluronic acid   

U.S. FDA Resources

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.

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

Publications indexed to this study:

Study ID Numbers:   KA 99005gs
First Received:   September 2, 2005
Last Updated:   September 2, 2005
ClinicalTrials.gov Identifier:   NCT00144820
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

Study placed in the following topic categories:
Osteoarthritis, Knee
Musculoskeletal Diseases
Hyaluronic Acid
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008




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