Clinical trial NCT04472091: Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain
Official title: Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Osteoarthritis
Knee Pain Chronic
Knee Pain Swelling
Knee Arthritis
Arterial Occlusion
Keywords: Knee osteoarthritis
Genicular artery embolization
Geniculate artery embolization
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with treatment related adverse events
timeFrame: 1 month post GAE
measure: Number of patients with treatment related adverse events
timeFrame: 6 months post GAE
measure: Number of patients with treatment related adverse events
timeFrame: 12 months post GAE
measure: Number of patients with treatment related adverse events
timeFrame: 24 months post GAE
Secondary outcomes:
measure: Mean change from baseline pain scores
timeFrame: Baseline to 1 month post GAE
measure: Mean change from baseline pain scores
timeFrame: Baseline to 6 months post GAE
measure: Mean change from baseline pain scores
timeFrame: Baseline to 12 months post GAE
measure: Mean change from baseline pain scores
timeFrame: Baseline 24 months post GAE
measure: Mean change from baseline knee function scores
timeFrame: Baseline to 1 month post GAE
measure: Mean change from baseline knee function scores
timeFrame: Baseline to 6 months post GAE
measure: Mean change from baseline knee function scores
timeFrame: Baseline to 12 months post GAE
measure: Mean change from baseline knee function scores
timeFrame: Baseline to 24 months post GAE
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Andrew C Picel, MD
role: PRINCIPAL_INVESTIGATOR
References: