GAE Using Embosphere Microspheres vs Corticosteroid Injections for Treatment of Symptomatic Knee OA (MOTION)

Study Purpose

This multicenter, prospective, interventional trial is designed to assess the outcome of subjects with symptomatic knee osteoarthritis (OA) that are randomized to treatment with either genicular artery embolization (GAE) using Embosphere Microspheres or steroid injection over a period of 24 months.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

Provides written informed consent.Age ≥21 years.Mild to severe knee pain, defined as a WOMAC Pain score of ≥8 out of 20 (in the target knee) Pain refractory to conservative therapies for at least 90 days prior to enrollment/randomization. Kellgren-Lawrence grade 1, 2, 3 or 4.Key

Exclusion Criteria:

Planned major surgical or endovascular procedures ≤ 30 days after the index procedure. Advanced atherosclerosis.Known history of rheumatoid or infectious arthritis. Prior knee replacement surgery of the target knee.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05818150
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Merit Medical Systems, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sandeep Bagla, MDCraig J McAsey, MD
Principal Investigator Affiliation Prostate Centers, USAAnderson Orthopedic Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Brazil, Canada, New Zealand, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis
Additional Details

This study is an IDE study. It is an RCT comparing GAE to steroid injection in the knee to treat knee osteoarthritis.

Arms & Interventions

Arms

Experimental: Genicular artery embolization with Embosphere Microspheres

Device: Embosphere Microspheres Embolic Agent: Embosphere Microspheres

Active Comparator: Corticosteroid Injection of the knee

Drug: Corticosteroid injection

Interventions

Device: - Embosphere Microspheres

Embolic Agent: Embosphere Microspheres

Drug: - Corticosteroid injection

Corticosteroid injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Georgetown University Medical Center, Washington, D.C., District of Columbia

Status

Recruiting

Address

Georgetown University Medical Center

Washington, D.C., District of Columbia, 20007

Site Contact

Nairman Nezami, MD

[email protected]

202-444-5478

MedStar Washington Hospital Center, Washington, D.C., District of Columbia

Status

Recruiting

Address

MedStar Washington Hospital Center

Washington, D.C., District of Columbia, 22010

Site Contact

John Smirniotopoulos, MD

[email protected]

1 (385) 766-9151

Emory University School of Medicine, Atlanta, Georgia

Status

Recruiting

Address

Emory University School of Medicine

Atlanta, Georgia, 30322

Site Contact

Will Lindquester, MD

[email protected]

1 (385) 766-9151

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60201

Site Contact

Ahsun Riaz, MD

[email protected]

1 (385) 766-9151

Saint Louis University, St Louis, Missouri

Status

Recruiting

Address

Saint Louis University

St Louis, Missouri, 63103

Site Contact

Sarah Dalton

[email protected]

314-617-2874

Atlantic Medical Imaging, Galloway, New Jersey

Status

Recruiting

Address

Atlantic Medical Imaging

Galloway, New Jersey, 08205

Site Contact

Christopher Kim, MD

[email protected]

1 (385) 766-9151

Rutgers Health, Newark, New Jersey

Status

Recruiting

Address

Rutgers Health

Newark, New Jersey, 07103

Site Contact

Saharsh Patel

[email protected]

1 (385) 766-9151

Northwell Health, Manhasset, New York

Status

Recruiting

Address

Northwell Health

Manhasset, New York, 11030

Site Contact

Chanell Wilkins

[email protected]

347-984-3523

Weill Cornell Medicine, New York, New York

Status

Not yet recruiting

Address

Weill Cornell Medicine

New York, New York, 10022

Site Contact

Daniel Holzwanger, MD

[email protected]

1 (385) 766-9151

Atlas Interventional, Williamsville, New York

Status

Recruiting

Address

Atlas Interventional

Williamsville, New York, 14221

Site Contact

Christa MacLean

[email protected]

1 (385) 766-9151

Prostate Centers USA, Raleigh, North Carolina

Status

Recruiting

Address

Prostate Centers USA

Raleigh, North Carolina, 27617

Site Contact

Ari Isaacson, MD

[email protected]

1 (385) 766-9151

Sunrise Vascular Center, Sanford, North Carolina

Status

Recruiting

Address

Sunrise Vascular Center

Sanford, North Carolina, 27330

Site Contact

Kelli Schrenk

[email protected]

919-589-6968

The Ohio State University, Columbus, Ohio

Status

Recruiting

Address

The Ohio State University

Columbus, Ohio, 43210

Site Contact

Gage Spears

[email protected]

614-293-8315

Cardiovascular Health Clinic, Oklahoma City, Oklahoma

Status

Recruiting

Address

Cardiovascular Health Clinic

Oklahoma City, Oklahoma, 73134

Site Contact

Blake Parsons, DO

[email protected]

1 (385) 766-9151

Prostate Centers USA, Falls Church, Virginia

Status

Recruiting

Address

Prostate Centers USA

Falls Church, Virginia, 22043

Site Contact

Sindhuja (Sindhu) Kommidi

[email protected]

732-783-1259

Prostate Centers USA, Leesburg, Virginia

Status

Recruiting

Address

Prostate Centers USA

Leesburg, Virginia, 20191

Site Contact

Sindhuja (Sindhu) Kommidi

[email protected]

732-783-1259

International Sites

Liverpool Hospital, Liverpool, Australia

Status

Not yet recruiting

Address

Liverpool Hospital

Liverpool, ,

Site Contact

Ross Copping, MD

[email protected]

1 (385) 766-9151

Hospital de Clínicas de Passo Fundo, Passo Fundo, Brazil

Status

Not yet recruiting

Address

Hospital de Clínicas de Passo Fundo

Passo Fundo, ,

Site Contact

Mateus Correa, MD

[email protected]

1 (385) 766-9151

University of Sao Paulo, São Paulo, Brazil

Status

Not yet recruiting

Address

University of Sao Paulo

São Paulo, ,

Site Contact

Andre Assis, MD

[email protected]

1 (385) 766-9151

Vancouver General Hospital, Vancouver, British Columbia, Canada

Status

Recruiting

Address

Vancouver General Hospital

Vancouver, British Columbia,

Takapuna, New Zealand

Status

Recruiting

Address

North Shore Hospital/ Te Whatu Ora - Waitemata

Takapuna, ,

Site Contact

Hector Gonzales

[email protected]

+64 4868920 ext 42231

University Hospitals Dorset, Bournemouth, United Kingdom

Status

Not yet recruiting

Address

University Hospitals Dorset

Bournemouth, ,

Site Contact

Claire Bent, MD

[email protected]

1 (385) 766-9151

Grange University Hospital, Cwmbran, United Kingdom

Status

Not yet recruiting

Address

Grange University Hospital

Cwmbran, , NP44 8YN

Site Contact

Nimit Goyal, MD

[email protected]

1 (385) 766-9151