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Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00144820
First received: September 2, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

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 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 ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00144820     History of Changes
Other Study ID Numbers: KA 99005gs
Study First Received: September 2, 2005
Last Updated: September 2, 2005
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
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013