- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00144820
Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Copenhagen Ø
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Copenhagen, Copenhagen Ø, Denmark, 2100
- Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pain measured on a visual scale on movement (VAS-movement)
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At rest (VAS-rest)
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During the night (VAS-night)
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Secondary Outcome Measures
Outcome Measure |
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KOOS scores (knee injury and osteoarthritis outcome score)
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Daily consumption of analgetics
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Cartilage and bone degradation markers
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The quadriceps circumference (cm), ability to bend (degrees flexion) and stretch (degrees extension) the knee joint
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Global assessment patient
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Global assessment investigator
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Collaborators and Investigators
Investigators
- Principal Investigator: Charlotte Lundsgaard, MD, Copenhagen Trial Unit (CTU)
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA 99005gs
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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