OA of the knee.
Conditions
Interventions
Inclusion interview, X-rays of the knee and filling out questionnaires.
Vena punction.
Six intra-articular injections of the afflicted
knee with Orthokin or placebo.
Every 3 months visiting treati
Sponsors
Dr. D.B.F. Saris
University Medical Center Utrecht
Department of Orthopaedics
PO box 85500
3508 GA, Utrecht
The Netherlands
+31 30 2506971
Eligibility
Inclusion criteria
Inclusion criteria: 1. Typical symptoms for osteoarthritis as judged by the physician; 2. Previous treatment more than 6 months ago; 3. Patient signed informed consent; 4. Patient > 18 years old; 5. Minimal 40 mm VAS pain; 6. Maximal 60 points Knee Society Rating Scale; 7. Maximal 60 points KOOS index.
Exclusion criteria
Exclusion criteria: 1. Participation in concurrent trials; 2. Participation in previous trials within 3 months; 3. Patient know with HIV, Hepatitis, CMV and Syphilis infections; 4. Alcohol and drug abuse; 5. Poor general health condition as judged by the treating physician; 6. Received hyaluronic acid and/or corticosteroid intra-articular injections into the afflicted knee within the last 6 months of baseline; 7. Intake of specific drugs, such as chondroitin sulfate, diacerein, n-glucosamine, piacledine, capsain within 2 weeks of the baseline visit; 8. Any concomitant painful or disabling disease of the spine, the hips or lower limbs that would interfere with evaluation of the afflicted knee; 9. Ipsilateral coxarhrosis and hip prothesis loosening; 10. Any clinically significant or symptomatic vascular or neurological disorder of the lower extremities; 11. All crystalline, inflammatory and infectious arthropathies; 12. Current diagnosis of osteomyelitis. OA grade IV; 13. Known immunodeficiency; 14. Corticosteroid usage; 15. Anti-coagulant usage and coagulopathy; 16. Morbid obesity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| X-rays. | — |
Contacts
Public ContactN.J.H. Raijmakers
University Medical Center Utrecht (UMCU), Department of Orthopaedics, P.O. Box 85500
Outcome results
None listed