RECRUITING

Geniculate Artery Embolization for Osteoarthritis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The need for exploration of more definitive and cost effective non-arthroplasty treatments of osteoarthritis (OA) has been demonstrated by the orthopedic and health economic research. Embolotherapy of neovessels associated with OA joints has been shown to be promising in patients with knee OA. There is a need for level one evidence drawn from randomized clinical trials to prove the safety, feasibility and efficacy of knee embolotherapy compared to standard of care. This randomized pilot study will assign 10 patients with mild-moderate OA to undergo geniculate artery embolization plus standard of care (defined in this study as: physical therapy and oral anti-inflammatory medications, with a maximum of 1 joint injection at the time of enrollment) and 10 patients to receive only medical standard of care (also having had a maximum of 1 joint injection prior to enrollment). The goal of this pilot study is to obtain preliminary estimates of safety and efficacy of embolotherapy to provide sustained symptom control and modify disease progression in patients with mild to moderate knee OA.

Official Title

Geniculate Artery Embolization for Osteoarthritis: Pilot Study

Quick Facts

Study Start:2022-02-01
Study Completion:2026-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04456569

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Unilaterally dominant symptomatic osteoarthritis (bilateral radiographic OA will not exclude)
  2. * Patients who are symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or 0-1 intra-articular injections of the affected knee)
  3. * Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee
  4. * Patients who are willing to comply with the protocol requirements and willing to undergo non-contrast MRI 1-30 days prior to procedure and at 12 months following procedure
  5. * Patients who are willing to comply with regular follow up during the 12 month follow-up period
  6. * Patients who have been evaluated by an orthopaedic surgeon or sports medicine provider and deemed to not be a current candidate for partial or total knee arthroplasty. These patients do, however, need to be considered a potential candidate for partial or total knee as an end point following the natural history of osteoarthritis.
  7. * Patients with WOMAC Score \>=6 in at least 2 categories
  1. * Patients with a weight \>250 pounds
  2. * Patients with advanced peripheral arterial disease (resting ABI \<= 0.9)
  3. * Patients with known significant peripheral arterial disease precluding common femoral catheterization
  4. * Patients who do smoke or have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
  5. * Patients with diabetes who have a hemoglobin A1C of \>9%
  6. * Patients who have undergone previous lower extremity embolization
  7. * Patients with uncontrolled emotional disorders per patient medical history
  8. * Patients with chronic pain syndrome or currently under a pain contract
  9. * Patients with anatomic variants involving the lower extremities which would increase the risk of non-target embolization
  10. * Patients with renal insufficiency based on an estimated GFR\<45 ml/min who are not already on hemodialysis.
  11. * Patients with an abnormal INR (\>1.5).
  12. * Patients with a platelet count \<50x109/L.
  13. * Patients who are currently receiving medications for anticoagulation which cannot safely be held for the procedure and for 7 days post-procedure.
  14. * Patients with a known severe allergy to iodine which cannot be adequately pre-medicated
  15. * Patients who are pregnant or intend to become pregnant within 6 months of the procedure
  16. * Patients with a contraindication to drugs used for moderate sedation during interventional procedures, including Midazolam and Fentanyl
  17. * Patients with a life expectancy \<60 months
  18. * Patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial
  19. * Patients with contraindications to medical and physical rehabilitative treatments of OA
  20. * Patients with known advanced atherosclerosis
  21. * Patients with known current or previous lower extremity fistula
  22. * Patients with rheumatoid arthritis or seronegative arthropathies
  23. * Patients with prior ipsilateral knee surgery.
  24. * Patients with WOMAC Pain Scale \< 6
  25. * Patients having received more than one steroid injection in the affected joint or an injection in the affected joint within 3 months of screening

Contacts and Locations

Study Contact

Connie Dale, MD
CONTACT
dalex179@umn.edu
Mary Farnsworth
CONTACT
612-624-9695
ewigx005@umn.edu

Principal Investigator

Reza Talaie, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Reza Talaie, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01
Study Completion Date2026-02-01

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2026-02-01

Terms related to this study

Keywords Provided by Researchers

  • Embolotherapy

Additional Relevant MeSH Terms

  • Osteo Arthritis Knee
  • Arthritis
  • Osteoarthritis
  • Osteoarthritis, Knee