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. 4140963, District of Columbia 4138106

Status

Recruiting

Address

Georgetown University Medical Center

Washington D.C. 4140963, District of Columbia 4138106, 20007

Site Contact

Nairman Nezami, MD

[email protected]

202-444-5478

MedStar Washington Hospital Center, Washington D.C. 4140963, District of Columbia 4138106

Status

Recruiting

Address

MedStar Washington Hospital Center

Washington D.C. 4140963, District of Columbia 4138106, 22010

Emory University School of Medicine, Atlanta 4180439, Georgia 4197000

Status

Recruiting

Address

Emory University School of Medicine

Atlanta 4180439, Georgia 4197000, 30322

Northwestern University, Chicago 4887398, Illinois 4896861

Status

Recruiting

Address

Northwestern University

Chicago 4887398, Illinois 4896861, 60201

Saint Louis University, St Louis 4407066, Missouri 4398678

Status

Recruiting

Address

Saint Louis University

St Louis 4407066, Missouri 4398678, 63103

Site Contact

Sarah Dalton

[email protected]

314-617-2874

Atlantic Medical Imaging, Galloway 7647784, New Jersey 5101760

Status

Recruiting

Address

Atlantic Medical Imaging

Galloway 7647784, New Jersey 5101760, 08205

Rutgers Health, Newark 5101798, New Jersey 5101760

Status

Recruiting

Address

Rutgers Health

Newark 5101798, New Jersey 5101760, 07103

Site Contact

Saharsh Patel

[email protected]

1 (385) 766-9151

Northwell Health, Manhasset 5125766, New York 5128638

Status

Recruiting

Address

Northwell Health

Manhasset 5125766, New York 5128638, 11030

Site Contact

Chanell Wilkins

[email protected]

347-984-3523

Weill Cornell Medicine, New York 5128581, New York 5128638

Status

Not yet recruiting

Address

Weill Cornell Medicine

New York 5128581, New York 5128638, 10022

Atlas Interventional, Williamsville 5144588, New York 5128638

Status

Recruiting

Address

Atlas Interventional

Williamsville 5144588, New York 5128638, 14221

Site Contact

Christa MacLean

[email protected]

1 (385) 766-9151

Prostate Centers USA, Raleigh 4487042, North Carolina 4482348

Status

Recruiting

Address

Prostate Centers USA

Raleigh 4487042, North Carolina 4482348, 27617

Sunrise Vascular Center, Sanford 4490329, North Carolina 4482348

Status

Recruiting

Address

Sunrise Vascular Center

Sanford 4490329, North Carolina 4482348, 27330

Site Contact

Kelli Schrenk

[email protected]

919-589-6968

The Ohio State University, Columbus 4509177, Ohio 5165418

Status

Recruiting

Address

The Ohio State University

Columbus 4509177, Ohio 5165418, 43210

Site Contact

Gage Spears

[email protected]

614-293-8315

Cardiovascular Health Clinic, Oklahoma City 4544349, Oklahoma 4544379

Status

Recruiting

Address

Cardiovascular Health Clinic

Oklahoma City 4544349, Oklahoma 4544379, 73134

Prostate Centers USA, Falls Church 4758390, Virginia 6254928

Status

Recruiting

Address

Prostate Centers USA

Falls Church 4758390, Virginia 6254928, 22043

Site Contact

Sindhuja (Sindhu) Kommidi

[email protected]

732-783-1259

Prostate Centers USA, Leesburg 4769125, Virginia 6254928

Status

Recruiting

Address

Prostate Centers USA

Leesburg 4769125, Virginia 6254928, 20191

Site Contact

Sindhuja (Sindhu) Kommidi

[email protected]

732-783-1259

International Sites

Liverpool Hospital, Liverpool 2159851, Australia

Status

Not yet recruiting

Address

Liverpool Hospital

Liverpool 2159851, ,

Hospital de Clínicas de Passo Fundo, Passo Fundo 3454857, Brazil

Status

Not yet recruiting

Address

Hospital de Clínicas de Passo Fundo

Passo Fundo 3454857, ,

University of Sao Paulo, São Paulo 3448439, Brazil

Status

Not yet recruiting

Address

University of Sao Paulo

São Paulo 3448439, ,

Vancouver General Hospital, Vancouver 6173331, British Columbia 5909050, Canada

Status

Recruiting

Address

Vancouver General Hospital

Vancouver 6173331, British Columbia 5909050,

Takapuna 2207740, New Zealand

Status

Recruiting

Address

North Shore Hospital/ Te Whatu Ora - Waitemata

Takapuna 2207740, ,

Site Contact

Hector Gonzales

[email protected]

+64 4868920 ext 42231

University Hospitals Dorset, Bournemouth 2655095, United Kingdom

Status

Not yet recruiting

Address

University Hospitals Dorset

Bournemouth 2655095, ,

Grange University Hospital, Cwmbran 2651654, United Kingdom

Status

Not yet recruiting

Address

Grange University Hospital

Cwmbran 2651654, , NP44 8YN