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Completed

NCT Number: NCT02850068

Geniculate Artery Embolization for the Treatment of Knee Pain

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.

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Key information

Conditions

Osteoarthritis of Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Hospitals, Chapel Hill, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Geniculate Artery Embolization

Device

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 names: Embozene Microspheres

Primary outcomes

  1. 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.

  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".

Secondary outcomes

  1. 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).

Other outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Geniculate Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis

Acronym: GAE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 29, 2016
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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