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Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00144820
Recruitment Status : Unknown
Verified August 2005 by Glostrup University Hospital, Copenhagen.
Recruitment status was:  Active, not recruiting
First Posted : September 5, 2005
Last Update Posted : September 5, 2005
Information provided by:
Glostrup University Hospital, Copenhagen

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Injection of Hyaluronan or Saline Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 251 participants
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.
Study Start Date : May 1999
Estimated Study Completion Date : November 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Primary Outcome Measures :
  1. Pain measured on a visual scale on movement (VAS-movement)
  2. At rest (VAS-rest)
  3. During the night (VAS-night)

Secondary Outcome Measures :
  1. KOOS scores (knee injury and osteoarthritis outcome score)
  2. Daily consumption of analgetics
  3. Cartilage and bone degradation markers
  4. The quadriceps circumference (cm), ability to bend (degrees flexion) and stretch (degrees extension) the knee joint
  5. Global assessment patient
  6. Global assessment investigator

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

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.

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

Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102
Copenhagen, Copenhagen Ø, Denmark, 2100
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Principal Investigator: Charlotte Lundsgaard, MD Copenhagen Trial Unit (CTU)

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 Posted: September 5, 2005    Key Record Dates
Last Update Posted: September 5, 2005
Last Verified: August 2005

Keywords provided by Glostrup University Hospital, Copenhagen:
Placebo controlled

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