Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 2, 2005

Last Updated Date

September 2, 2005

Start Date ^ICMJE

May 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Pain measured on a visual scale on movement (VAS-movement)
At rest (VAS-rest)
During the night (VAS-night)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

Official Title ^ICMJE

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.

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Osteoarthritis, Knee

Intervention ^ICMJE

Drug: Injection of Hyaluronan or Saline

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

251

Completion Date

November 2001

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00144820

Responsible Party

Study ID Numbers ^ICMJE

KA 99005gs

Study Sponsor ^ICMJE

Glostrup University Hospital,Copenhagen

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Charlotte Lundsgaard, MD

Copenhagen Trial Unit (CTU)

Information Provided By

Glostrup University Hospital,Copenhagen

Verification Date

August 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP