Geniculate Artery Embolization for the Treatment of Knee Pain

NCT02850068 | Completed Results FDA Device

• 1 other identifier: 16-1969
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis Of Knee

Outcome Measures

Primary Outcomes (2)

• Patient Function (Units on a Scale)

  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.

  6 months

• Patient Pain (mm)

  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".

  6 months

Secondary Outcomes (1)

• Reduction in Medication (Percentage of Participants With a Reduction in Medication Therapy at Month 6)

  6 months

Other Outcomes (1)

• Patient Complications (Number of Participants With Complications at Month 6)

  6 months

Study Arms (1)

Geniculate Artery Embolization

EXPERIMENTAL

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).

Device: Geniculate Artery Embolization

Interventions

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.

Also known as: Embozene Microspheres

Geniculate Artery Embolization

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (2)

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Vascular Institute of Virginia

Woodbridge, Virginia, 22193, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Associate Director of Clinical Research Operations, Department of Radiology
• Organization: University of North Carolina at Chapel Hill

rad_research@med.unc.edu

919-966-4997

Study Officials

• Ari Isaacson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: July 29, 2016
• Study Start: January 25, 2017
• Primary Completion: August 3, 2018
• Study Completion: August 3, 2018
• Last Updated: August 20, 2019
• Results First Posted: August 20, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)