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Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

Primary Purpose

Knee Osteoarthritis, Knee Pain Chronic, Knee Pain Swelling

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Genicular artery embolization (GAE)
Sponsored by
Andrew Picel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Genicular artery embolization, Geniculate artery embolization

Eligibility Criteria

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

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

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Genicular artery embolization

Arm Description

Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study. The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE.

Outcomes

Primary Outcome Measures

Number of patients with treatment related adverse events
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Number of patients with treatment related adverse events
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Number of patients with treatment related adverse events
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Number of patients with treatment related adverse events
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Secondary Outcome Measures

Mean change from baseline pain scores
Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
Mean change from baseline pain scores
Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
Mean change from baseline pain scores
Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
Mean change from baseline pain scores
Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
Mean change from baseline knee function scores
Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
Mean change from baseline knee function scores
Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
Mean change from baseline knee function scores
Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
Mean change from baseline knee function scores
Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.

Full Information

First Posted
July 9, 2020
Last Updated
April 22, 2023
Sponsor
Andrew Picel
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1. Study Identification

Unique Protocol Identification Number
NCT04472091
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrew Picel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Pain Chronic, Knee Pain Swelling, Knee Arthritis, Arterial Occlusion
Keywords
Knee osteoarthritis, Genicular artery embolization, Geniculate artery embolization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Genicular artery embolization
Arm Type
Experimental
Arm Description
Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study. The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE.
Intervention Type
Device
Intervention Name(s)
Genicular artery embolization (GAE)
Intervention Description
Participants will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ).
Primary Outcome Measure Information:
Title
Number of patients with treatment related adverse events
Description
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
1 month post GAE
Title
Number of patients with treatment related adverse events
Description
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
6 months post GAE
Title
Number of patients with treatment related adverse events
Description
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
12 months post GAE
Title
Number of patients with treatment related adverse events
Description
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
24 months post GAE
Secondary Outcome Measure Information:
Title
Mean change from baseline pain scores
Description
Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
Time Frame
Baseline to 1 month post GAE
Title
Mean change from baseline pain scores
Description
Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
Time Frame
Baseline to 6 months post GAE
Title
Mean change from baseline pain scores
Description
Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
Time Frame
Baseline to 12 months post GAE
Title
Mean change from baseline pain scores
Description
Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
Time Frame
Baseline 24 months post GAE
Title
Mean change from baseline knee function scores
Description
Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
Time Frame
Baseline to 1 month post GAE
Title
Mean change from baseline knee function scores
Description
Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
Time Frame
Baseline to 6 months post GAE
Title
Mean change from baseline knee function scores
Description
Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
Time Frame
Baseline to 12 months post GAE
Title
Mean change from baseline knee function scores
Description
Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.
Time Frame
Baseline to 24 months post GAE

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provide informed consent Age ≥ 40 years Moderate to severe knee pain (VAS >40 mm) 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 Kellgren-Lawrence radiographic grade 1, 2, or 3 disease MRI features of active synovitis (synovial thickening and/or enhancement on MRI). Ineligibility or refusal of surgical management. Local knee tenderness Exclusion Criteria: Rheumatoid or infectious arthritis Advanced lower extremity atherosclerosis that would limit selective angiography Local knee infection Prior knee surgery (excluding arthroscopic/meniscal interventions) Uncorrectable coagulopathy (INR>1.8, platelets<50,000/µL) Iodine allergy resulting in anaphylaxis Chronic renal insufficiency (serum creatinine >2 mg/dL) Life expectancy less than 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew C Picel, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew C Picel, MD
Phone
650-736-6109
Email
apicel@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

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