| Trial name or title |
Intra‐articular injections of hyaluronan versus 20 MI NaCl versus placebo in treatment of knee osteoarthritis: a randomised, double‐blind, placebo controlled single centre trial |
| Methods |
|
| Participants |
Males and females 60 years and above with clinical, radiological and possible arthroscopical verified knee OA; knee pain on the day of examination scoring more than 20 mm on a VAS at baseline.
Exclusion: less than 60 y, unconsciousness, psychosis, demens, ingestion of drugs that may influence the results of the clinical examinations, inflammatory diseases of the joints, RA or other inflammatory arthritis as diagnosed by ACR criteria, contraindication to Hyalgan treatment, previous intra‐articular 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 2 mth inclusive intra‐articular injections of steroids, any other condition that might interfere with the efficacy assessment or completion of the trial |
| Interventions |
4 weekly injections of :
Hyaluronan (2 ml sodium hyaluronate),
Placebo (2 ml isotonic saline), Excessive saline (20 ml isotonic saline) |
| Outcomes |
Pain measured on a VAS on movement; at rest and during the night; KOOS scores; daily consumption of analgesics; cartilage and bone degradation markers; quadriceps circumference (cm); abililty to bend (degrees flexion); and stretch (degrees extension); global assessment patient; global assessment investigator |
| Starting date |
This study is no longer recruiting patients. |
| Contact information |
Charlotte Lundsgaard, MD, Principal Investigator, Copenhagen Trial Unit (CTU), H:S Rigshospitalet. dept. 7102, Copenhagen, Copenhagen 0, 2100, Denmark |
| Notes |
251 consecutive patients were randomised. 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. |
