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NCT06550024 | RECRUITING | Osteo Arthritis Knee

SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Sponsor:

CrannMed

Brief Summary:

An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).

Condition or disease

Osteo Arthritis Knee

Joint Diseases

Musculoskeletal Diseases

Rheumatic Diseases

Arthritis

Osteoarthritis

Intervention/treatment

SakuraBead Resorbable Microspheres

Corticosteroid Injection

Phase

NA

Detailed Description:

To compare safety and efficacy of SakuraBead with corticosteroid injection for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on a total of approximately 89 patients who will be followed up for a period of 2 years.

Study Type : INTERVENTIONAL
Estimated Enrollment : 89 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Actual Study Start Date : 2024-11-28
Estimated Primary Completion Date : 2025-10
Estimated Study Completion Date : 2027-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 79 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Subject is able and willing to provide written informed consent, and
  • 2. Clinical diagnosis of knee OA, and
  • 3. Moderate to severe knee pain (WOMAC Pain ≥ 10), and
  • 4. Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and
  • 5. Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
  • 6. Age ≥ 40 years and \< 80 years, and
  • 7. Able to comply with all treatments and follow-up visits.
Exclusion Criteria
  • 1. Severe knee OA (Kellgren-Lawrence grade 4), or
  • 2. Current infection of target joint, or
  • 3. Life expectancy less than 36 months, or
  • 4. Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
  • 5. Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
  • 6. Prior knee replacement surgery in the target knee, or
  • 7. Pain score of \>3 NRS on the non-target knee, or
  • 8. An acute internal derangement of the target knee, or
  • 9. History of uncorrectable coagulopathy, or
  • 10. Prior iodinated contrast reaction resulting in anaphylaxis, or
  • 11. Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, or planning pregnancy in the following 12 months, or
  • 12. Has undergone an invasive treatment (including but not limited to: corticosteroid injection, hyaluronic acid injections, nerve ablation) in the target knee within the past 3 months, or
  • 13. Contraindication to MRI, or
  • 14. At the discretion of the Principal Investigator
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization

Location Details

NCT06550024

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

University of Alabama Medicine

Birmingham, Albama, United States, 35233

RECRUITING

United States, California

Harbor UCLA Medical Center

Torrance, California, United States, 90502

RECRUITING

United States, North Carolina

IR Centers

Raleigh, North Carolina, United States, 27617

RECRUITING

United States, Oregon

Orthopedic and Fracture Specialists (O&FS)

Portland, Oregon, United States, 97225

RECRUITING

United States, Virginia

IR Centers

Leesburg, Virginia, United States, 20176

RECRUITING

Georgia,

Bokhua Memorial Cardiovascular Center

Tbilisi, Georgia,

RECRUITING

Uzbekistan,

Nano Medical Clinic

Tashkent, Uzbekistan, 100095