RECRUITING

Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis

Talk to us

Conditions

Knee OsteoarthritisKnee Osteoarthritis (Knee OA)Knee Osteoarthritis (OA)OsteoarthritisKnee painMSK painMusculoskeletal PainOsteoarthritis of the kneeGAEGenicular artery embolizationGeniculate artery embolizationMSK embolizationMusculoskeletal EmbolizationEmbolizationMusculoskeletalTemporary Embolization

Quick Navigation

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

Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.

Official Title

Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study

Quick Facts

Study Start:2025-05-01
Study Completion:2026-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06859164

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 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients aged 40-80
  2. * Bilateral or unilateral knee pain attributed to osteoarthritis (treat the knee with greater pain-if equal, patient chooses)
  3. * Grade 2-4 osteoarthritis on standing weight-bearing knee radiographs per the Kellgren-Lawrence grading scale
  4. * Knee pain \> 6 months, refractory to conservative non-operative management, and scored ≥ 4 on Visual Analog Scale (VAS) (e.g., rest, activity modification, weight control, bracing, supervised physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral opiates, intra-articular hyaluronic acid, PRP, stem cells, and/or oral/injectable corticosteroids)
  5. * Refusal of intra-articular corticosteroid injection
  1. * Active malignancy
  2. * Active infection of the affected knee
  3. * Corticosteroid injection of the affected knee within 3 months of enrollment
  4. * Rheumatoid arthritis or other seronegative arthropathy
  5. * Previous surgery of the affected knee (e.g., meniscus repair, meniscectomy, anterior cruciate ligament (ACL)/posterior cruciate ligament (PCL) reconstruction, chondroplasty, microfracture, loose-body removal, synovectomy, lateral release, patellar/quadriceps tendon repair, total or partial knee replacement, osteotomy, cartilage transplant), except diagnostic arthroscopy
  6. * Grade 0-1 osteoarthritis per Kellgren-Lawrence grading scale of the affected knee
  7. * Pregnancy or expected pregnancy
  8. * GFR \< 60 mL/min/1.73 m²
  9. * Anaphylactic reaction to iodinated contrast
  10. * Moderate to severe pain in other ipsilateral lower-limb joints (ankle, hip) with VAS \> 4
  11. * Body weight \> 400 lbs (unsafe for angiography)
  12. * Peripheral arterial disease of the treated extremity (Rutherford Grade 2 or greater)
  13. * Type 1 diabetes mellitus
  14. * Long-acting corticosteroid use within 6 months (3 months for short-acting)
  15. * History or other evidence of acute kidney injury (AKI)
  16. * History of reaction to contrast media, bronchial asthma, or allergic disorders
  17. * History of hypersensitivity to gadolinium-based contrast agents (GBCAs)
  18. * Chronic widespread generalized pain \>4 on VAS pain scale, including neuropathic pain
  19. * Major depressive disorder within 2 years before screening
  20. * Other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
  21. * Suicide attempt or suicidal behavior within 30 days before screening
  22. * Diagnosis of fibromyalgia
  23. * Considering total knee replacement in the next year
  24. * Any other condition, unwillingness, or inability that, in the investigator's opinion, could jeopardize the subject's safety or protocol compliance

Contacts and Locations

Study Contact

Faisal F Al-Qawasmi
CONTACT
8478124513
t-9falqa@uchicago.edu
Osman Ahmed, MD
CONTACT
OAhmed@bsd.uchicago.edu

Principal Investigator

Osman Ahmed, MD
PRINCIPAL_INVESTIGATOR
University of Chicago Department of Radiology

Study Locations (Sites)

University of Chicago
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Osman Ahmed, MD, PRINCIPAL_INVESTIGATOR, University of Chicago Department of Radiology

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 Date2025-05-01
Study Completion Date2026-11-30

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2026-11-30

Terms related to this study

Keywords Provided by Researchers

  • Osteoarthritis
  • Knee pain
  • MSK pain
  • Musculoskeletal Pain
  • Osteoarthritis of the knee
  • GAE
  • Genicular artery embolization
  • Geniculate artery embolization
  • MSK embolization
  • Musculoskeletal Embolization
  • Embolization
  • Musculoskeletal
  • Temporary Embolization

Additional Relevant MeSH Terms

  • Knee Osteoarthritis
  • Knee Osteoarthritis (Knee OA)
  • Knee Osteoarthritis (OA)