Knee osteoarthritis Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]
Conditions
Interventions
Patients are randomized with a 1:1 ratio to either carboplasty or placebo. Allocation was performed by a research assistant blinded to the treatment using a computerized random number generator.
Sponsors
The VAD Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients willing and able to give informed consent 2. Age 30-80 years 3. Body mass index <35 kg/m² 4. Symptomatic knee OA grade II or III diagnosed by radiographic Kellgren and Lawrence 5. History of at least 6 months of conservative treatment and no improvement of symptoms* 6. Evidence of edema-like marrow signals by MRI 7. Patients medically able to undergo carboplasty 8. Patients willing and able to follow the rehabilitation protocol
Exclusion criteria
Exclusion criteria: 1. Prior history of articular infection 2. Prior history of knee arthroscopy 3. Chronic use of anticoagulation 4. Patients diagnosed with cancer or currently undergoing chemotherapy 5. Patients unable to undergo MRI 6. Patients who are pregnant or intend to become pregnant during the first year after initial enrollment 7. History of autoimmune disease 8. Evidence of HIV or chronic hepatitis B or C viral infections 9. Current drug or alcohol abuse 10. Patients deemed by the investigator as unlikely to comply with the protocol 11. Vascular or neurological abnormalities affecting the lower extremities 12. Any form of inflammatory arthritis 13. Uncontrolled systemic disease (diabetes mellitus, hyperthyroidism, etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee pain evaluated by the visual analog scale of pain from 0 to 10 at baseline and 1 year after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain related to different activities measured using the Knee injury and Osteoarthritis Outcome Score (KOOS) from 0 (really symptomatic) to 100 (asymptomatic) at baseline and after 1-year post-treatment 2. Morphological evaluation and bone marrow edema measured using magnetic resonance imaging at baseline and after 1-year post-treatment 3. Adverse events measured using a questionnaire and self-reported monthly for 1-year post-treatment 4. Treatment failure, defined as total knee arthroplasty due to refractory pain despite the treatment, at 1-year post-treatment | — |
Countries
India
Contacts
Public ContactVijay Vad
Outcome results
None listed