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

ConditionsKnee OsteoarthritisKnee Osteoarthritis (Knee OA)Knee Osteoarthritis (OA)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorUniversity of Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 40-80

Bilateral or unilateral knee pain attributed to osteoarthritis (treat the knee with greater pain-if equal, patient chooses)

Grade 2-4 osteoarthritis on standing weight-bearing knee radiographs per the Kellgren-Lawrence grading scale

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)

Disqualifiers

Active malignancy

Active infection of the affected knee

Corticosteroid injection of the affected knee within 3 months of enrollment

Rheumatoid arthritis or other seronegative arthropathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Genicular Artery Embolization

    Procedure/Surgery

    Embolization of genicular arteries that demonstrate neoangiogenesis or blush on angiogram.

  • Lipiodol

    Device

    3:1 emulsion of Lipiodol to Optiray

  • Simple angiogram

    Procedure/Surgery

    Simple angiogram of the genicular arteries

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: GAE ArmExperimental treatment 3 interventions
Group B: Sham ArmSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Reduction in KOOS pain subscore

Percent change in KOOS pain subscale score, scaled to a range of 0-100, from baseline to 3 months post-randomization of both GAE and sham groups.

Time frame
3 months

Secondary outcomes

1

WOMAC knee pain and dysfunction

Reduction in knee pain and dysfunction (WOMAC) at 1, 3, 6, 9, and 12 months.

Time frame
1, 3, 6, 9, and 12 months.
2

KOOS pain and dysfunction

Absolute reduction in knee pain and dysfunction (KOOS) at 1, 3, 6, 9, and 12 months

Time frame
1, 3, 6, 9, and 12 months
3

VAS Score

Visual Analog Score (VAS) for pain at 0, 1, 6, 9, and 12 months post treatment

Time frame
0, 1, 6, 9, and 12 months
4

Crossover

Rate of cross-over from sham to GAE at 3 months

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Source ClinicalTrials.gov
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