Clinical trial NCT04592562: Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis
Official title: Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis: A Pilot Study to Assess Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Genicular Artery Embolization
Knee Pain
Knee Osteoarthritis
Genicular Artery
Embolization
Pain Management
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients who meet study eligibility will undergo the novel Genicular artery embolization procedure by a licensed Interventional Radiologist at the University of Chicago Medical Center.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this study is to perform a feasibility study to show the effectiveness of the genicular artery embolization procedure in reducing bilateral or unilateral osteoarthritic knee pain at 12 months as measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, Knee Injury and Osteoarthritis Outcome (KOOS) score, and Oswestry Disability Index.

Detailed description: This is a single-center, pilot study to assess the feasibility of a study show the effectiveness of the genicular artery embolization (GAE) in reducing arthritic pain and dysfunction associated with mild to moderate Bilateral or unilateral osteoarthritis of the knee. Patients with bilateral or unilateral Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale, will be offered enrollment to the study. Following a screening questionnaire, these patients will then be enrolled in this study. Baseline MRI will be obtained prior to the GAE procedure. Follow up intervals will include 3, 6, 9, and 12 months with the primary objective measured by a clinician as the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, Knee Injury and Osteoarthritis Outcome (KOOS) score, and Oswestry Disability Index at the 12-month follow up visit. Patients will also undergo 1 year follow up MRI to be interpreted by a diagnostic radiologist with subspecialty training in musculoskeletal radiology. This radiologist will compare the treated knee to the baseline screening according to the WORMS classification (Whole Organ Magnetic Resonance Scoring) to assess for radiologic changes of osteoarthritis and any adverse effects.

Eligibility criteria: Inclusion Criteria:

We intend to include patients who meet the following criteria in the study:

1. Patients aged 40-80
2. Bilateral or Unilateral knee pain attributed to osteoarthritis
3. Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale
4. Knee pain \>6 months refractory to conservative medical management (NSAIDs, paracetamol, intra-articular injections, physiotherapy/exercise, weight loss, etc.)

Exclusion Criteria:

* We plan to exclude patients who meet any of the following criteria:

  1. Active malignancy
  2. Active infection of the affected knee
  3. Platelets \<50,000
  4. INR \>1.8 (unless on anticoagulation that can be reversed)
  5. Corticosteroid injection of the affected knee within 3 months
  6. Rheumatoid arthritis or other seronegative arthropathy
  7. Previous surgery (excluding arthroscopy) of the affected knee
  8. Grade 4 per Kellgren-Lawrence Grading Scale of the affected knee
  9. Pregnancy or expected pregnancy
  10. GFR \<30
  11. Anaphylactic reaction to iodinated contrast
  12. Moderate to severe pain in other lower limb joints
  13. Body weight \>400 lbs. (Procedure table weight limit)
  14. BMI \>50
  15. Patients at high risk for contrast nephropathy

Primary outcomes:
measure: WOMAC Scale
timeFrame: 12 Months
measure: KOOS Scale
timeFrame: 12 Months
measure: Oswestry Disability Index
timeFrame: 12 Months
Secondary outcomes:
measure: WOMAC for Knee Pain and Dysfunction
timeFrame: 12 Months
measure: KOOS for Knee Pain and Dysfunction
timeFrame: 12 Months
measure: Oswestry Disability Index for Knee Pain and Dysfunction
timeFrame: 12 Months
measure: VAS for Pain
timeFrame: 12 Months
measure: Six-Minute Walk Test for Functional Improvement
timeFrame: 12 months
measure: Thirty-Second Chair Test for Performance
timeFrame: 12 Months
measure: Opiate Usage
timeFrame: 12 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
Study officials:
affiliation: University of Chicago
name: Osmanuddin Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References: