Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This study is an IDE study. It is an RCT comparing GAE to steroid injection in the knee to treat knee osteoarthritis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genicular artery embolization with Embosphere Microspheres | Experimental | Device: Embosphere Microspheres Embolic Agent: Embosphere Microspheres |
|
| Corticosteroid Injection of the knee | Active Comparator | Drug: Corticosteroid injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embosphere Microspheres | Device | Embolic Agent: Embosphere Microspheres |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint | Clinical Success defined as ≥50% improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale from baseline to 6 months without the need for additional intervention. | 6 months |
| Primary Safety Endpoint | Freedom from treatment-related safety events through 6 months (180 days) following the index procedure. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects achieving Clinical Success | Number of subjects achieving Clinical Success | 3, 12, and 24 months |
| Numerical rating scale (NRS) | Pain score assessed using numerical rating scale (NRS) |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sandeep Bagla, MD | Prostate Centers, USA | Principal Investigator |
| Craig J McAsey, MD | Anderson Orthopedic Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Care Long Beach Medical Center | Long Beach | California | 90806 | United States | ||
| Georgetown University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40050421 | Derived | Bent C, McAsey CJ, Bagla S. Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid iNjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study Protocol Summary. Cardiovasc Intervent Radiol. 2025 Apr;48(4):551-558. doi: 10.1007/s00270-025-03994-z. Epub 2025 Mar 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Enrolled subjects will be randomized 1:1 to either geniculate artery embolization or corticosteroid injection for treatment of symptomatic knee osteoarthritis.
Not provided
Not provided
Not provided
Not provided
| Corticosteroid injection | Drug | Corticosteroid injection |
|
|
| baseline, 3, 6, 12 and 24 months |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 22010 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Biotech Clinical Research/ Georgia Vascular Institute | College Park | Georgia | 30337 | United States |
| Northwestern University | Chicago | Illinois | 60201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Saint Louis University | St Louis | Missouri | 63103 | United States |
| Atlantic Medical Imaging | Galloway | New Jersey | 08205 | United States |
| Rutgers Health | Newark | New Jersey | 07103 | United States |
| Northwell Health | Manhasset | New York | 11030 | United States |
| Weill Cornell Medicine | New York | New York | 10022 | United States |
| Atlas Interventional | Williamsville | New York | 14221 | United States |
| Prostate Centers USA | Raleigh | North Carolina | 27617 | United States |
| Sunrise Vascular Center | Sanford | North Carolina | 27330 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Cardiovascular Health Clinic | Oklahoma City | Oklahoma | 73134 | United States |
| Prostate Centers USA | Falls Church | Virginia | 22043 | United States |
| Prostate Centers USA | Leesburg | Virginia | 20191 | United States |
| Liverpool Hospital | Liverpool | Australia |
| Hospital de Clínicas de Passo Fundo | Passo Fundo | Brazil |
| University of Sao Paulo | São Paulo | Brazil |
| Vancouver General Hospital | Vancouver | British Columbia | Canada |
| CHUM - Centre hospitalier de l'Université de Montréal | Montreal | H2X OC1 | Canada |
| North Shore Hospital/ Te Whatu Ora - Waitemata | Takapuna | New Zealand |
| University Hospitals Dorset | Bournemouth | United Kingdom |
| Grange University Hospital | Cwmbran | NP44 8YN | United Kingdom |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D014221 | Triamcinolone |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
Not provided
Not provided