Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-05-31

Study Completion Date

2001-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Keywords

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Hyaluronan Gonarthrosis Osteoarthritis,knee Double-blinded Placebo controlled Randomised

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Injection of Hyaluronan or Saline

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Charlotte Lundsgaard, MD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen Trial Unit (CTU)

Locations

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Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102

Copenhagen, Copenhagen Ø, Denmark

Site Status

Countries

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Denmark

References

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Lundsgaard C, Dufour N, Fallentin E, Winkel P, Gluud C. Intra-articular sodium hyaluronate 2 mL versus physiological saline 20 mL versus physiological saline 2 mL for painful knee osteoarthritis: a randomized clinical trial. Scand J Rheumatol. 2008 Mar-Apr;37(2):142-50. doi: 10.1080/03009740701813103.

Reference Type DERIVED

PMID: 18415773 (View on PubMed)

Other Identifiers

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KA 99005gs

Identifier Type: -

Identifier Source: org_study_id