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Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2005 by Glostrup University Hospital, Copenhagen.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00144820
First Posted: September 5, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Glostrup University Hospital, Copenhagen
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144820


Locations
Denmark
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00144820     History of Changes
Other Study ID Numbers: KA 99005gs
First Submitted: September 2, 2005
First Posted: September 5, 2005
Last Update Posted: December 9, 2005
Last Verified: August 2005

Keywords provided by Glostrup University Hospital, Copenhagen:
Hyaluronan
Gonarthrosis
Osteoarthritis,knee
Double-blinded
Placebo controlled
Randomised

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents