Knee Osteoarthritis (Knee OA)
Conditions
Brief summary
Multi-center, prospective, randomized trial of GAE using Nexsphere-F against steroid injection
Interventions
genicular artery embolization
DRUGCorticosteroid Injection
Corticosteroid Injection
Sponsors
Next Biomedical Co., Ltd.
North American Science Associates Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has localized knee pain * Must be an appropriate candidate for arterial vascular access procedure
Exclusion criteria
* Known sensitivity or allergy to implant materials * Unable or unwilling to comply with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 6 and 12-month post treatment | Changes in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scale ranges from 0 to 96 with higher scores equating to greater pain, stiffness and difficulty with activities of daily living. |
| Serious Adverse Events (SAE) | Treatment, 1,3,6,9 and 12-month post treatment | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC total score | 9 month post treatment | Changes in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scale ranges from 0 to 96 with higher scores equating to greater pain, stiffness and difficulty with activities of daily living |
Countries
United States
Contacts
Primary ContactZiv J Haskal, MD
Outcome results
None listed