Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis

Knee Osteoarthritis Clinical Trial

— GAE  

Official title:

Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis: A Pilot Study to Assess Feasibility

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04592562
• Other study ID #: IRB20-0868
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2022
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: November 1, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• the Terumo Hydropearl® microspheres device
Genicular artery embolization (GAE) is a new, minimally invasive investigational not yet approved therapy. In previous studies, this procedure has provided pain relief in patients with mild to moderate OA in the short to midterm. We will be utilizing the Terumo Hydropearl® microspheres particle beads during the GAE procedures. The procedure will take place utilizing fluoroscopic and ultrasound guidance. Following catheterization of the femoral artery, angiography of the affected limb will be performed to define the genicular arterial anatomy. Genicular arteries demonstrating abnormal vascularity and corresponding to the site of the patient's pain will be catheterized and embolized using microspheres. Prior to and after embolization, parametric imaging will be performed utilizing proprietary software to quantify changes in blood flow to the target area The intended use of the Terumo Hydropearl® microspheres device is to embolize the geniculate artery branch.

Locations

Country	Name	City	State
United States	University of Chicago Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC Scale	The reduction of Bilateral or unilateral knee pain and dysfunction associated with mild to moderate osteoarthritis at 12 months as measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score	12 Months
Primary	KOOS Scale	The reduction of Bilateral or unilateral knee pain and dysfunction associated with mild to moderate osteoarthritis at 12 months as measured by the Knee Injury and Osteoarthritis Outcome (KOOS) score	12 Months
Primary	Oswestry Disability Index	The reduction of Bilateral or unilateral knee pain and dysfunction associated with mild to moderate osteoarthritis at 12 months as measured by the Oswestry Disability Index	12 Months
Secondary	WOMAC for Knee Pain and Dysfunction	To assess reduction in knee pain and dysfunction at 3, 6, and 9-months for subjects undergoing the GAE procedure using the WOMAC scale	12 Months
Secondary	KOOS for Knee Pain and Dysfunction	To assess reduction in knee pain and dysfunction at 3, 6, and 9-months for subjects undergoing the GAE procedure using the KOOS scale	12 Months
Secondary	Oswestry Disability Index for Knee Pain and Dysfunction	To assess reduction in knee pain and dysfunction at 3, 6, and 9-months for subjects undergoing the GAE procedure using the Oswestry Disability Index	12 Months
Secondary	VAS for Pain	To report the outcomes of Visual Analog Score (VAS) for pain at 0, 3, 6, 9, and 12 months post.	12 Months
Secondary	Six-Minute Walk Test for Functional Improvement	To determine and report six-minute walk test performance and to assess functional improvement at baseline, 3, 6, 9, and 12 months	12 months
Secondary	Thirty-Second Chair Test for Performance	To determine and report thirty-second chair stand test performances and to assess functional improvement at baseline, 3, 6, 9, and 12 months.	12 Months
Secondary	Opiate Usage	Change in usage of opiate or opiate-equivalent medications calculated by using the internal opioid change log, kept and updated by the study team from baseline to 12 months	12 Months