Summary

Eligibility
for people ages 40-79 (full criteria)
Location
at Torrance, California and other locations
Dates
study started
completion around

Description

Summary

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

Details

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.

Keywords

Osteo Arthritis Knee, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Arthritis, Osteoarthritis, Genicular Artery Embolization, GAE, Knee Embolization, Knee OA, Knee Osteoarthritis, Collagen Diseases, SakuraBead Resorbable Microspheres, Corticosteroid Injection, Genicular Artery Embolization (GAE)

Eligibility

You can join if…

Open to people ages 40-79

  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.

You CAN'T join if...

  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

Locations

  • Harbor UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • University of Alabama Medicine accepting new patients
    Birmingham Alabama 35233 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CrannMed
ID
NCT06550024
Study Type
Interventional
Participants
Expecting 89 study participants
Last Updated