Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

NCT00144820 | Unknown Phase 4

• 1 other identifier: KA 99005gs
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Hyaluronan; Gonarthrosis; Osteoarthritis,knee; Double-blinded; Placebo controlled; Randomised

Outcome Measures

Primary Outcomes (3)

• Pain measured on a visual scale on movement (VAS-movement)

• At rest (VAS-rest)

• During the night (VAS-night)

Secondary Outcomes (6)

• 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

Interventions

Injection of Hyaluronan or Saline DRUG

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

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

Copenhagen, Copenhagen Ø, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 18415773 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Charlotte Lundsgaard, MD

  Copenhagen Trial Unit (CTU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: May 1, 1999
• Study Completion: November 1, 2001
• Last Updated: September 5, 2005

Record last verified: 2005-08

Locations

DK (1)