Clinical trial NCT00144820: Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: Hyaluronan
Gonarthrosis
Osteoarthritis,knee
Double-blinded
Placebo controlled
Randomised
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2005-09-05
Enrollment: 251
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Pain measured on a visual scale on movement (VAS-movement)
measure: At rest (VAS-rest)
measure: During the night (VAS-night)
Secondary outcomes:
measure: KOOS scores (knee injury and osteoarthritis outcome score)
measure: Daily consumption of analgetics
measure: Cartilage and bone degradation markers
measure: The quadriceps circumference (cm), ability to bend (degrees flexion) and stretch (degrees extension) the knee joint
measure: Global assessment patient
measure: Global assessment investigator
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102
state: Copenhagen Ø
Study officials:
affiliation: Copenhagen Trial Unit (CTU)
name: Charlotte Lundsgaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.