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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of Hyaluronan or Saline | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pain measured on a visual scale on movement (VAS-movement) | ||
| At rest (VAS-rest) | ||
| During the night (VAS-night) |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS scores (knee injury and osteoarthritis outcome score) | ||
| Daily consumption of analgetics | ||
| Cartilage and bone degradation markers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlotte Lundsgaard, MD | Copenhagen Trial Unit (CTU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102 | Copenhagen | Copenhagen Ø | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18415773 | Derived | 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. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| The quadriceps circumference (cm), ability to bend (degrees flexion) and stretch (degrees extension) the knee joint |
| Global assessment patient |
| Global assessment investigator |
| D012216 |
| Rheumatic Diseases |
| D017670 |
| Sodium Compounds |