Knee Osteoarthritis (Knee OA)
Conditions
Brief summary
Study in patients with knee osteoarthritis treated by embolization using NBGM200
Interventions
DEVICEembolization therapy
MSK embolization
Sponsors
Next Biomedical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Osteoarthritis proven by MR-imaging
Exclusion criteria
* Current local infection * Life expectancy less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome score (KOOS-12) | 6 months post treatment | Knee Injury and Osteoarthritis Outcome score (KOOS-12) is to evaluate the pain, function and quality of life. The total score ranges from 0 to 100, where higher scores indicate better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale(VAS) | 6 months post treatment | Visual Analog Scale(VAS) is to evaluate the pain from 0 to 10. Higher scores indicate worse outcomes, representing more severe pain |
| Whole Organ Magnetic Resonance Imaging Score (WORMS) | 6 months post treatment | Whole Organ Magnetic Resonance Imaging Score (WORMS) is a semi-quantitative scoring method for multi-feature, whole-organ evaluation of knee OA based on MRI. The total score ranges from 0 to 332, with higher scores indicating worse outcomes. |
Countries
Belgium, Netherlands
Outcome results
None listed