Osteoarthritis of the knee
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. With a history of chronic (for at least 3 months) knee joint pain more than 35-mm on 0- to 100-mm visual analogue scale 2. Radiographically documented grades 1-3 osteoarthritis of the knee, grade according to the Kellgren-Lawrence radiographic classification scale 3. BMI ranging between 20 and 32 4. Requiring infiltration in monolateral knee 5. Possibility for observation during follow-up period
Exclusion criteria
Exclusion criteria: 1. Requiring infiltration in both knees 2. BMI more than 33 3. Suffering from polyarticular disease 4. Previous knee arthroscopy within last year 5. HA or steroid intra-articular infiltration within last 3 months 6. Past history of infectious disease 7. Compromised host 8. Systemic autoimmune disease 9. Anemia with hemoglobin under 10g/dl 10. Blood disorders 11. Treatment with anticoagulant drugs (Aspirin, Warfarin) 12. Having undergone treatment with steroids during 3 months before inclusion in this study 13. Treatment with NSAIDs during 2 weeks before its inclusion in this study 14. Patients who had malignancy during 5 years before inclusion in this study 15. Patients who do not have a voluntary consent capacity 16. Patients who cannot have a consent with document 17. Patients whom the doctor has determined that it is not suitable for this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events during the treatment and follow-up period. 1. Shock 2. Pain and stiffness 3. Swelling 4. Local heat | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The percentage of patients having a 50% decrease in the summed score for the Visual Analogue Scale from baseline to week 24. 2. Serum hyaluronic acid concentration rate before and after treatment 3. Improvement of felction and extension angle of the knee 4. Improvement rate of Japanese Knee Osteoarthritis Measure 5. Improvement of Japanese Orthopaedics Association score | — |
Countries
Japan
Contacts
University of Tsukuba Hospital Department of Rehabilitation