Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT00144820|
Recruitment Status : Unknown
Verified August 2005 by Glostrup University Hospital, Copenhagen.
Recruitment status was: Active, not recruiting
First Posted : September 5, 2005
Last Update Posted : September 5, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Drug: Injection of Hyaluronan or Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||251 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||May 1999|
|Study Completion Date :||November 2001|
- Pain measured on a visual scale on movement (VAS-movement)
- At rest (VAS-rest)
- During the night (VAS-night)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144820
|Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102|
|Copenhagen, Copenhagen Ø, Denmark, 2100|
|Principal Investigator:||Charlotte Lundsgaard, MD||Copenhagen Trial Unit (CTU)|