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Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

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ClinicalTrials.gov Identifier: NCT04472091
Recruitment Status : Not yet recruiting
First Posted : July 15, 2020
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Andrew Picel, Stanford University

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Knee Pain Chronic Knee Pain Swelling Knee Arthritis Arterial Occlusion Device: Genicular artery embolization (GAE) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : November 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Genicular artery embolization

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.

Device: Genicular artery embolization (GAE)
Participants will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ).




Primary Outcome Measures :
  1. Number of patients with treatment related adverse events [ Time Frame: 1 month post GAE ]
    Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  2. Number of patients with treatment related adverse events [ Time Frame: 6 months post GAE ]
    Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  3. Number of patients with treatment related adverse events [ Time Frame: 12 months post GAE ]
    Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  4. Number of patients with treatment related adverse events [ Time Frame: 24 months post GAE ]
    Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0


Secondary Outcome Measures :
  1. Mean change from baseline pain scores [ Time Frame: Baseline to 1 month post GAE ]
    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."

  2. Mean change from baseline pain scores [ Time Frame: Baseline to 6 months post GAE ]
    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."

  3. Mean change from baseline pain scores [ Time Frame: Baseline to 12 months post GAE ]
    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."

  4. Mean change from baseline pain scores [ Time Frame: Baseline 24 months post GAE ]
    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."

  5. Mean change from baseline knee function scores [ Time Frame: Baseline to 1 month post GAE ]
    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.

  6. Mean change from baseline knee function scores [ Time Frame: Baseline to 6 months post GAE ]
    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.

  7. Mean change from baseline knee function scores [ Time Frame: Baseline to 12 months post GAE ]
    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.

  8. Mean change from baseline knee function scores [ Time Frame: Baseline to 24 months post GAE ]
    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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04472091


Locations
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United States, California
Stanford University
Palo Alto, California, United States, 94305
Contact: Andrew C Picel, MD    650-736-6109    apicel@stanford.edu   
Sponsors and Collaborators
Andrew Picel
Investigators
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Principal Investigator: Andrew C Picel, MD Stanford University
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Responsible Party: Andrew Picel, Assistant Clinical Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04472091    
Other Study ID Numbers: 57046
IDE G200111 ( Other Identifier: FDA )
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Andrew Picel, Stanford University:
Knee osteoarthritis
Genicular artery embolization
Geniculate artery embolization
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases