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Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis (OA)

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ClinicalTrials.gov Identifier: NCT03362957
Recruitment Status : Active, not recruiting
First Posted : December 5, 2017
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

Purpose: To evaluate embolization as a treatment for OA related knee pain versus placebo to demonstrate the actual effect of embolization on pain and disability.

Participants: There will be 21 subjects enrolled over the age 40 with knee pain secondary to arthritis.

Procedures (methods): This will be a single-blinded randomized-controlled study of GAE versus placebo in a small population with knee pain secondary to arthritis to determine safety and efficacy. Clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for geniculate artery embolization, and follow-up visits at 24 hours, 2 weeks, 1, 3, 6, & 12 months. An MRI may be performed after the 1-month visit.


Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Device: Geniculate Artery Embolization Diagnostic Test: Sham Procedure Not Applicable

Detailed Description:

This will be a single-blinded randomized-controlled study of GAE versus placebo in a small population with knee pain secondary to arthritis to determine safety and efficacy. After Institutional Review Board (IRB) approval of a written informed consent and over, approximately a 24 month duration, N=21 subjects will be recruited. Only subjects ≥ 40 years will be screened for study recruitment. Subjects will be randomized in a 2:1 ratio of GAE:Placebo and will be blinded from study treatment (see flow chart below). The placebo procedure will be a diagnostic angiogram of the knee, without embolization. Appropriate measures will be taken to ensure patients and nursing staff caring for the patient are blinded to assignment. Each patient will be told at the time of recruitment that they may be randomly assigned to sham, but if after 1 month they have not had symptom improvement, their assigned procedure would be revealed and, if they had undergone a sham procedure, they will be allowed to proceed with embolization. This second procedure should be shorter than a complete angiogram and embolization, as the detailed angiogram will not need to be repeated, and therefore both arms will have similar total radiation dose.

Clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for geniculate artery embolization, and follow-up visits at 24 hours, 2 weeks, 1, 3, 6, & 12 months. An MRI may be performed after the 1-month visit.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This will be a single-blinded randomized-controlled study of GAE versus placebo in a small population with knee pain secondary to arthritis to determine safety and efficacy. The placebo procedure will be a diagnostic angiogram of the knee, without embolization. Appropriate measures will be taken to ensure patients and nursing staff caring for the patient are blinded to assignment. Each patient will be told at the time of recruitment that they may be randomly assigned to sham, but if after 1 month they have not had symptom improvement, their assigned procedure would be revealed and, if they had undergone a sham procedure, they will be allowed to proceed with embolization.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Placebo-Controlled Single Blinded Study of Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: GAE Procedure
Patients will be randomized to receive the Geniculate Artery Embolization Procedure
Device: Geniculate Artery Embolization
Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.

Sham Comparator: Sham Procedure
Patients will be randomized to a sham procedure.
Diagnostic Test: Sham Procedure
Patients will receive a sham procedure, which will include a diagnostic angiogram

Experimental: Crossover Arm
If after 1 month patients see no improvement, they will be unblinded and crossover to receive the Geniculate Artery Embolization Procedure
Device: Geniculate Artery Embolization
Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.




Primary Outcome Measures :
  1. Patient function (arbitrary units) [ Time Frame: 6 months ]
    Western Ontario and McMaster University Osteoarthritis Index (WOMAC) will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding rheumatic symptoms in the subcategories of pain (5 items), stiffness (2 items), and physical function (17 items). Individuals select the level of difficulty they have performing various tasks using a 5 point Likert scale (0=None, 1=Slightly, 3=Very, 4=Extremely). Then, results are scored with a total maximum score of 96. A higher score indicates more difficulty in each of the categories.

  2. Patient pain (mm) [ Time Frame: 6 months ]
    The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". Pain will be assessed at each of the patient's follow-up visits and used to measure the change from baseline (prior to the GAE procedure). The investigators will use this to measure if the patient's pain level decreases.


Secondary Outcome Measures :
  1. Reduction in Medication (arbitrary units) [ Time Frame: 6 months ]
    Reduction in the number or strength of previously initiated OA medical therapy (e.g. NSAIDs) at 6 months follow-up, which will be summarized using counts and simple statistics (i.e., mean number of patients with reduction in medication).


Other Outcome Measures:
  1. Patient complications (arbitrary units) [ Time Frame: 6 months ]
    The number and description of complications, adverse events, or poor outcomes that are secondary to the GAE procedure, which will be summarized using counts and simple statistics (i.e., mean number of patients with complications.)



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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:

Moderate to severe knee pain (visual analog scale (VAS) > 50 mm), and Pain refractory to at least 3 months* of conservative therapies (anti- inflammatory drugs, or physical therapy, or muscle strengthening, or intra- articular injections), and Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee.

Exclusion Criteria:

Current local infection, or Life expectancy less than 6 months, or Known advanced atherosclerosis, or Rheumatoid or infectious arthritis, or Prior knee surgery, or Uncorrectable coagulopathy including international normalized ratio (INR) > 2.5 or platelets < 30,000, or Iodine allergy resulting in anaphylaxis, or Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 obtained within the past 30 days.


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): NCT03362957


Locations
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United States, North Carolina
UNC Hospitals
Chapel Hill, North Carolina, United States, 27599
United States, Virginia
Vascular Institute of Virginia
Woodbridge, Virginia, United States, 22193
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Medtronic
Investigators
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Principal Investigator: Ari Isaacson, MD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03362957     History of Changes
Other Study ID Numbers: 17-2701
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
embolization
vascular
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases