Geniculate Artery Embolization for Knee Osteoarthritis

NCT03835988 | Withdrawn FDA Device

• 1 other identifier: REB19-0007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective cohort study to study the effectiveness and safety profile of geniculate artery embolization for the treatment of symptomatic knee osteoarthritis.

Conditions

Osteo Arthritis Knee

Keywords

Embolization

Outcome Measures

Primary Outcomes (2)

• Patient Pain (mm): visual analog scale

  Severity of pain as assessed by visual analog scale. The visual analog scale is a 100 mm horizontal line with 0 mm correlating with "No Pain" and 100 mm with "Worst Possible Pain". Accompanying the verbal description is an illustrative guide correlating values to facial expressions. Patients mark their responses with a single vertical line. Results will be recorded prior to the procedure and afterwards at each follow-up visit to measure for changes in knee pain.

  1 year

• Patient function (arbitrary units)

  Knee injury and Osteoarthritis Outcome Score (KOOS) will be used to measure joint function. This is a questionnaire in which questions regarding pain, other symptoms, function in activities of daily living, function in sport and recreation and knee-related quality of life are answered to calculate subscale scores. Each subscale (symptoms, activities of daily living, sport and recreation, quality of life) is scored from 0 to 100 with 0 representing extreme symptoms and 100 indicating no symptoms). The questionnaire will be completed at follow-up evaluations to measure change in each subscale from baseline (prior to intervention). Investigators will analyze scores to determine if patient's subjective joint function changes.

  1 year

Secondary Outcomes (3)

• Medication use (arbitrary units)

  1 year

• Physical function (arbitrary units)

  1 year

• Synovitis (arbitrary units)

  1 year

Other Outcomes (1)

• Patient complications (arbitrary units)

  1 year

Study Arms (1)

Geniculate Artery Embolization

EXPERIMENTAL

Patients undergoing geniculate artery embolization. Patients will be assessed and followed post-procedurally to detect changes in knee pain and function. Medication use, adverse events and performance based tests of physical function will also be recorded. A pre-procedural MRI will be compared to a 6 month post-procedure MRI to assess for changes in synovitis and assess for complications.

Device: Geniculate Artery Embolization

Interventions

Geniculate Artery Embolization DEVICE

Embolization is a procedure completed by an Interventional Radiologist in which abnormal blood vessels are blocked for treatment purposes. In the case of geniculate artery embolization, abnormal blood vessels which supply your knee joint are blocked in an effort to reduce inflammation and subsequently and reduce pain and improve joint function.

Also known as: Embozene Embolic Particles, Embosphere Embolic Particles

Geniculate Artery Embolization

Eligibility Criteria

• Age: 21 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 for at least 3 months of conservative therapies (anti-inflammatory drugs, physical therapy, muscle strengthening or intra-articular injections), and
• Kellgren-Lawrence grade 1, 2 or 3 on knee radiograph, and
• MRI features of active synovitis (Synovial thickening and/or enhancement on MRI using pre-gadolinium sagittal T2-weighted/proton-density sequences and post-gadolinium T1 weighted imaging, respectively), and
• Willing, able and mentally competent to provide written informed consent (to ensure that all study subjects demonstrate an understanding of the risks of the procedure and participate in the informed consent), and
• Not eligible for surgical arthroplasty within 1 year of estimated procedure date

You may not qualify if:

• Major surgery within the past six weeks (excluding arthroscopic/meniscal interventions), or
• Ipsilateral knee intra-articular injection in the last 3 months, or
• Pregnant or attempting to become pregnant during study period, or
• Current local infection, or
• Life expectancy less than 6 months, or
• Known advanced atherosclerosis, or
• Rheumatoid or seronegative arthropathies, or
• Infectious arthritis, or
• Prior knee surgery (excluding arthroscopic/meniscal interventions), or
• Uncorrectable coagulopathy including international normalized ratio (INR) \> 1.5 or platelets \< 50,000, or
• Iodinated contrast allergy resulting in anaphylaxis, or
• Inability to lay supine on an angiographic table \>500 lbs due to table weight limits, or
• Renal dysfunction as defined as glomerular filtration rate \< 30 mL/min/1.73m2 obtained within the past 30 days, or
• Patients with documented noncompliance with previous medical care, or
• Patients with certain psychiatric disorders such as schizophrenia, borderline personality disorder, uncontrolled depression, or mental/cognitive impairment that limits the individual's ability to understand the proposed therapy, or

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

South Healthy Campus

Calgary, Alberta, T3M 1M4, Canada

Location

Related Publications (2)

• Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.

  PMID: 14613558 BACKGROUND

• Guermazi A, Roemer FW, Hayashi D, Crema MD, Niu J, Zhang Y, Marra MD, Katur A, Lynch JA, El-Khoury GY, Baker K, Hughes LB, Nevitt MC, Felson DT. Assessment of synovitis with contrast-enhanced MRI using a whole-joint semiquantitative scoring system in people with, or at high risk of, knee osteoarthritis: the MOST study. Ann Rheum Dis. 2011 May;70(5):805-11. doi: 10.1136/ard.2010.139618. Epub 2010 Dec 27.

  PMID: 21187293 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 11, 2019
• Study Start: March 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: December 31, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)