Geniculate Artery Embolization for Knee Osteoarthritis

NCT ID: NCT03835988

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-12-31

Brief Summary

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

Detailed Description

Purpose: The investigators aim to determine whether geniculate artery embolization is a safe treatment for symptomatic knee osteoarthritis and confirm published reports of sustained post-procedural pain relief, improved physical function and investigate potential improvements in joint function quantitatively through imaging and targeted assessments.

Participants:Twenty patients with moderate to severe knee pain, pain refractory for 3 months of conservative therapies, imaging features of symptomatic osteoarthritis and ineligible for arthroplasty for 1 year.

Procedures (methods): Patients will undergo a brief clinical evaluation to verify eligibility through inclusion and exclusion criteria in addition to a comprehensive joint pain treatment history will be recorded including active analgesic and anti-inflammatory use. A pre-procedural MRI will be completed to assess the extent of their osteoarthritis, signs of active synovitis and vascular anatomy of the knee. Evaluations post geniculate artery embolization will occur at 24 hours, 1, 6 and 12 months to assess for changes in knee pain and joint function and monitor adverse events. An MRI will be performed at the 6 month visit to detect changes in synovitis and exclude complications.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Geniculate Artery Embolization

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.

Group Type: EXPERIMENTAL

Geniculate Artery Embolization

Intervention Type: 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.

Interventions

Geniculate Artery Embolization

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.

Intervention Type: DEVICE

Other Intervention Names

Embozene Embolic Particles; Embosphere Embolic Particles

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Absence of synovitis on MRI

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Ani Mirakhur

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

South Healthy Campus

Calgary, Alberta, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 14613558 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21187293 (View on PubMed)

Other Identifiers

REB19-0007

Identifier Type: -

Identifier Source: org_study_id