Degenerative osteoarthritis of the knee
Conditions
Interventions
Two groups:To compare the effect of mesenchymal stem cells and hyaluronic acid on treating osteoarthritis of the knee, after intra-articular injection of both
Sponsors
Prof. Kevin HO Ki Wai
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients must comply with all the following criteria in order to be included in the study 1. Male and female subjects aged between 18 and < 65; 2. All patients must provide their written consent; 3. All patients must be affected by primary osteoarthritis of the knee (according to ACR - American College of Rheumatology - classification); In case a patient shows a bilateral OA, it will be included and treated for both knees; 4. All patients must have pain symptoms since at least 2 months; 5. All patients must experience, during the inclusion visit (T0), a pain level higher than or equal to 5.0 cm on a VAS scale of 10 cm; 6.All patients should have at least 8 years of school education; 7.Radiological evidence of osteoarthritis with Kellgren and Lawrence grade 2 and 3.
Exclusion criteria
Exclusion criteria: The presence of one or more of the following criteria will exclude the patient from the study: 1. Patients with previous cases of alcoholism or drug abuse; 2. Pregnancy and breast-feeding; 3. Presence of serious pathologies; 4. Hypersensitivity towards hyaluronic acid; 5. Intra-articular infiltrations of hyaluronic acid or steroids that are in the process of being administered or that have been interrupted since less than 3 months; 6. Steroid-based systemic therapy in progress or interrupted since less than 1 month and/or anti-clotting drugs; 7. History of fractures and/or severe traumas of the knee bone; 8. Significant hematologic diseases; 9. Non-consenting patients who have not provided the written Informed Consent; 10. Mechanical instability, ligamentous laxity/deficiency and gross deformity; 11. Isolated meniscal tear without evident of osteoarthritis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional osteoarthritis scores including WOMAC,KSS and KSFS, SF-36 and VAS pain scores will be assessed at 2 weeks, 3 months, 6 months, 9 months and 12 months post-operation;Radiologic knee osteoarthritis will be assessed by MRI-and X-ray before operation, 3 months and 12 months post-operation;Adverse event will be monitored during the study; | — |
Secondary
| Measure | Time frame |
|---|---|
| Analgesic/NSAIDs consumption;Crackling sounds with movement (subjective evaluation);Per-articular swelling (thigh and knee circumference evaluation); | — |
Countries
China
Contacts
Public ContactProf. Kevin HO Ki Wai
Outcome results
None listed