search
Back to results

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

Primary Purpose

Knee Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
the Terumo Hydropearl® microspheres device
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Knee Osteoarthritis focused on measuring Genicular Artery Embolization, Knee Pain, Knee Osteoarthritis, Genicular Artery, Embolization, Pain Management

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GAE Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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
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
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
VAS for Pain
To report the outcomes of Visual Analog Score (VAS) for pain at 0, 3, 6, 9, and 12 months post.
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
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.
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

Full Information

First Posted
October 14, 2020
Last Updated
November 2, 2022
Sponsor
University of Chicago
search

1. Study Identification

Unique Protocol Identification Number
NCT04592562
Brief Title
Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis
Acronym
GAE
Official Title
Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis: A Pilot Study to Assess Feasibility
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Genicular Artery Embolization, Knee Pain, Knee Osteoarthritis, Genicular Artery, Embolization, Pain Management

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GAE Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
the Terumo Hydropearl® microspheres device
Intervention Description
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.
Primary Outcome Measure Information:
Title
WOMAC Scale
Description
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
Time Frame
12 Months
Title
KOOS Scale
Description
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
Time Frame
12 Months
Title
Oswestry Disability Index
Description
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
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
WOMAC for Knee Pain and Dysfunction
Description
To assess reduction in knee pain and dysfunction at 3, 6, and 9-months for subjects undergoing the GAE procedure using the WOMAC scale
Time Frame
12 Months
Title
KOOS for Knee Pain and Dysfunction
Description
To assess reduction in knee pain and dysfunction at 3, 6, and 9-months for subjects undergoing the GAE procedure using the KOOS scale
Time Frame
12 Months
Title
Oswestry Disability Index for Knee Pain and Dysfunction
Description
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
Time Frame
12 Months
Title
VAS for Pain
Description
To report the outcomes of Visual Analog Score (VAS) for pain at 0, 3, 6, 9, and 12 months post.
Time Frame
12 Months
Title
Six-Minute Walk Test for Functional Improvement
Description
To determine and report six-minute walk test performance and to assess functional improvement at baseline, 3, 6, 9, and 12 months
Time Frame
12 months
Title
Thirty-Second Chair Test for Performance
Description
To determine and report thirty-second chair stand test performances and to assess functional improvement at baseline, 3, 6, 9, and 12 months.
Time Frame
12 Months
Title
Opiate Usage
Description
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
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.) Exclusion Criteria: 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 Patients at high risk for contrast nephropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osmanuddin Ahmed, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs