Knee osteoarthritis Musculoskeletal Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Primary (idiopathic) femorotibial knee osteoarthritis (medial, lateral, or medial + lateral) 2. Diagnosis based on the clinical + radiographic criteria of the American College of Rheumatology for idiopathic knee osteoarthritis (knee pain + osteophytes + at least 1 of the following 3 criteria: age > 50 years, stiffness < 30 minutes, crepitus) 3. Knee symptoms mainly attributable to femorotibial osteoarthritis (medial, lateral, or medial + lateral), confirmed on physical examination 4. Pain and reduced lower limb mobility mainly attributable to the knee under study 5. Clinical presentation with average pain = 5 (moderately severe) on the Visual Analogue Scale (VAS) for pain, on most days in the past month 6. Radiographic evidence of femorotibial osteoarthritis (medial, lateral, or medial + lateral) of Kellgren–Lawrence grade II or III, on a weight-bearing AP knee radiograph of the knee under study performed within the past year 7. Age = 65 years 8. Willingness to participate in the study and sign the informed consent 9. If both knees meet the inclusion criteria, the knee selected for the study will be the one with the higher average pain on most days in the past month on the Visual Analogue Scale (VAS) for pain; if pain intensity is equal in both knees, the selected knee will be the one with more frequent pain (greater number of painful days in the past month)
Exclusion criteria
Exclusion criteria: 1. History of knee surgery and of injection with platelet-rich plasma, or with bone marrow, adipose tissue, or umbilical cord concentrate 2. History of knee injection with hyaluronic acid or hylan within the past year 3. History of percutaneous invasive knee procedure in the past 3 months 4. Sepsis 5. Skin integrity alterations or infection of the knee or iliac crest 6. Inability to walk and perform transfers independently 7. Known immunosuppression, due to disease or therapy 8. Active oncological disease in the affected knee or in the iliac bone 9. Active infectious disease or fever 10. Depression 11. Fibromyalgia 12. Severe mental illness 13. Severe cognitive impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee pain measured using visual analogue scale (VAS) at baseline (pre-treatment) and at 1, 3, 6 and 12 months after treatment | — |
Countries
Portugal