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Geniculate Artery Embolization for the Treatment of Knee Pain (GAE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02850068
Recruitment Status : Completed
First Posted : July 29, 2016
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE July 27, 2016
First Posted Date  ICMJE July 29, 2016
Results First Submitted Date  ICMJE July 8, 2019
Results First Posted Date  ICMJE August 20, 2019
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE January 25, 2017
Actual Primary Completion Date August 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
  • Patient Function (Units on a Scale) [ Time Frame: 6 months ]
    Western Ontario and McMaster University Osteoarthritis Index will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding rheumatic symptoms, stiffness, pain and how it affects the ability to function. Participants are asked to rate each question on a scale from 0 to 4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely) for the level of difficulty to complete each task. The categories are then totaled for an overall score out of 96. Higher values indicate greater levels of pain, stiffness, and functional limitations.
  • 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".
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
  • Patient function (arbitrary units) [ Time Frame: 6 months ]
    Western Ontario and McMaster University Osteoarthritis Index will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding rheumatic symptoms, stiffness, pain and how it affects the ability to function.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
Reduction in Medication (Percentage of Participants With a Reduction in Medication Therapy at Month 6) [ 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 (percentage of participants with a reduction in medication therapy at month 6 months).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
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).
Current Other Pre-specified Outcome Measures
 (submitted: August 5, 2019)
Patient Complications (Number of Participants With Complications at Month 6) [ 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 (number of participants with complications at month 6)
Original Other Pre-specified Outcome Measures
 (submitted: July 28, 2016)
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.)
 
Descriptive Information
Brief Title  ICMJE Geniculate Artery Embolization for the Treatment of Knee Pain
Official Title  ICMJE Geniculate Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis
Brief Summary This study is to test a new treatment method, geniculate artery embolization (GAE), to reduce the severity of pain and disability caused by knee osteoarthritis.
Detailed Description

Purpose: The primary aims of this study are to determine if geniculate artery embolization (GAE) will reduce the severity of pain as well as global disability (resulting from the combination of pain, stiffness and difficulty performing daily activities) caused by knee OA and if it can be performed safely. The secondary aim is to determine if GAE can result in the decreased necessity for ongoing conservative OA therapies such as medication therapy and joint injections.

Participants: Twenty patients with knee osteoarthritis resulting in knee pain that is refractory to conservative therapies, who are not planning to undergo surgery within 6 months.

Procedures (methods): This will be an open label 24-month pilot study with a small population undergoing GAE 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, 1, 3 & 6 months. An MRI will be performed at the 1-month visit to detect a change in synovial vascularity and to exclude complication.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis Of Knee
Intervention  ICMJE Device: Geniculate Artery Embolization
Geniculate artery embolization (GAE) is a new procedure that is being used to reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA). Embolization is a procedure where physicians intentionally block the blood vessels to specific areas of the body to prevent blood flow to that region. By doing this, the decrease in blood flow will decrease the size of the area of interest. In this case, the goal is to decrease the size of inflammatory tissue around the knee, resulting in improvement of pain, stiffness and difficulty performing daily activities from OA.
Other Name: Embozene Microspheres
Study Arms  ICMJE Experimental: Geniculate Artery Embolization
Patients in this study will receive the geniculate artery embolization (GAE) procedure. The primary aims will be to determine if geniculate artery embolization (GAE) will reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA).
Intervention: Device: Geniculate Artery Embolization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 3, 2018
Actual Primary Completion Date August 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 obtained within the past 30 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02850068
Other Study ID Numbers  ICMJE 16-1969
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ari Isaacson, MD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP