Arterial Occlusion, Knee Arthritis, Knee Osteoarthritis, Knee Pain Chronic, Knee Pain Swelling
Conditions
Keywords
Knee osteoarthritis, Genicular artery embolization, Geniculate artery embolization
Brief summary
The objective of this investigation is to evaluate the safety of the geniculate artery embolization (GAE) procedure with HydroPearl® Microspheres in 30 patients with knee pain caused by osteoarthritis with 24 months follow-up. The GAE procedure is an arterial embolization procedure that blocks abnormal blood vessels caused be knee arthritis in order to evaluate the effect on knee pain.
Interventions
DEVICEGenicular artery embolization (GAE)
Participants will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ).
Sponsors
Andrew Picel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provide informed consent 2. Age ≥ 40 years 3. Moderate to severe knee pain (VAS \>40 mm) 4. Pain refractory to 3 months of conservative treatments, including at least one of the following: * a. Anti-inflammatory medications * b. Physical therapy * c. Intra-articular injections 5. Kellgren-Lawrence radiographic grade 1, 2, or 3 disease 6. MRI features of active synovitis (synovial thickening and/or enhancement on MRI). 7. Ineligibility or refusal of surgical management. 8. Local knee tenderness
Exclusion criteria
1. Rheumatoid or infectious arthritis 2. Advanced lower extremity atherosclerosis that would limit selective angiography 3. Local knee infection 4. Prior knee surgery (excluding arthroscopic/meniscal interventions) 5. Uncorrectable coagulopathy (INR\>1.8, platelets\<50,000/µL) 6. Iodine allergy resulting in anaphylaxis 7. Chronic renal insufficiency (serum creatinine \>2 mg/dL) 8. Life expectancy less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with treatment related adverse events | 1 month post GAE | Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline pain scores | Baseline to 1 month post GAE | Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents no pain and 100 mm represents worse possible pain. |
| Mean change from baseline knee function scores | Baseline to 1 month post GAE | Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of 0 indicates no symptoms and 4 indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms. |
Countries
United States
Outcome results
None listed