N/A
N=11
Geniculate Artery Embolization for Knee Osteoarthritis
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT04951479 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in KOOS Pain Score — 33 score on a scale — p=0.00041
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gel-Bead embolization (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Anish Ghodadra
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in KOOS Pain Score |
33 | 0.00041 sig |
| SECONDARY Change in Knee-related Functionality |
39 | 0.008 sig |
| SECONDARY Change in KOOS Quality of Life Scale |
42 | 0.001 sig |
| SECONDARY Change in 30-second Chair Stand Test |
4.5 | 0.00797 sig |
| SECONDARY 6-minute Walk Test |
— | — |
Summary
The purpose of this study is to perform a prospective case series to determine efficacy of transcatheter arterial embolization in treating knee osteoarthritis related pain, improving functionality, and reducing opiate usage in patients with mild to moderate knee osteoarthritis who have failed conservative management.
The Gel-Bead embolization particles will be used to perform geniculate artery embolization (GAE) for the purposes of treatment of osteoarthritis-related knee pain.
Eligibility Criteria
Inclusion Criteria
- Patients between ages 18 and 75 with moderate/severe knee pain secondary to primary osteoarthritis. Moderate/severe pain will be defined as pain 30 mm to 100 mm on the Visual Analog Pain Scale (where 0 denotes 'no pain' and 100 mm denotes worst pain imaginable')
- Grade 1, 2, or 3 osteoarthritis on the Kellgren-Lawrence grading scale on knee x-ray in the last 6 months
- Pain must be refractory to 3 months of medical management (which may include a combination of oral analgesics, intraarticular steroids, viscosupplementation, opioid therapy, etc)
- Patients willing and able to consent to the study
Exclusion Criteria
- Kidney dysfunction defined as an estimated GFR 1.6
- Platelets < 50,000
- Significant atherosclerosis that would limit angiography
- Active malignancy
- Active pregnancy
- Appropriate candidate for knee replacement surgery determined by clinical and physical examination
- Recent within 3 months, or active cigarette user
Data sourced from ClinicalTrials.gov (NCT04951479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.