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

NCT04592562 | Completed DMC FDA Device

• 1 other identifier: IRB20-0868
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Genicular Artery Embolization; Knee Pain; Knee Osteoarthritis; Genicular Artery; Embolization; Pain Management

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• WOMAC for Knee Pain and Dysfunction

  12 Months

• KOOS for Knee Pain and Dysfunction

  12 Months

• Oswestry Disability Index for Knee Pain and Dysfunction

  12 Months

• VAS for Pain

  12 Months

• Six-Minute Walk Test for Functional Improvement

  12 months

Study Arms (1)

GAE Arm

EXPERIMENTAL

Patients who meet study eligibility will be scheduled to undergo the Genicular Artery Embolization procedure and will subsequent be followed for 12 months after their procedure.

Device: the Terumo Hydropearl® microspheres device

Interventions

the Terumo Hydropearl® microspheres device 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.

GAE Arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We intend to include patients who meet the following criteria in the study:
• Patients aged 40-80
• Bilateral or Unilateral knee pain attributed to osteoarthritis
• Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale
• Knee pain \>6 months refractory to conservative medical management (NSAIDs, paracetamol, intra-articular injections, physiotherapy/exercise, weight loss, etc.)

You may not qualify if:

• We plan to exclude patients who meet any of the following criteria:
• Active malignancy
• Active infection of the affected knee
• Platelets \<50,000
• INR \>1.8 (unless on anticoagulation that can be reversed)
• Corticosteroid injection of the affected knee within 3 months
• Rheumatoid arthritis or other seronegative arthropathy
• Previous surgery (excluding arthroscopy) of the affected knee
• Grade 4 per Kellgren-Lawrence Grading Scale of the affected knee
• Pregnancy or expected pregnancy
• GFR \<30
• Anaphylactic reaction to iodinated contrast
• Moderate to severe pain in other lower limb joints
• Body weight \>400 lbs. (Procedure table weight limit)
• BMI \>50

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Agnosia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Osmanuddin Ahmed, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 19, 2020
• Study Start: September 22, 2021
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)