Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis (SHAM-PAIN)

May 14, 2025 updated by: University of Chicago

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)
  • Refusal of intra-articular corticosteroid injection

Exclusion Criteria:

  • 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
  • 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
  • Grade 0-1 osteoarthritis per Kellgren-Lawrence grading scale of the affected knee
  • Pregnancy or expected pregnancy
  • GFR < 60 mL/min/1.73 m²
  • Anaphylactic reaction to iodinated contrast
  • Moderate to severe pain in other ipsilateral lower-limb joints (ankle, hip) with VAS > 4
  • Body weight > 400 lbs (unsafe for angiography)
  • Peripheral arterial disease of the treated extremity (Rutherford Grade 2 or greater)
  • Type 1 diabetes mellitus
  • Long-acting corticosteroid use within 6 months (3 months for short-acting)
  • History or other evidence of acute kidney injury (AKI)
  • History of reaction to contrast media, bronchial asthma, or allergic disorders
  • History of hypersensitivity to gadolinium-based contrast agents (GBCAs)
  • Chronic widespread generalized pain >4 on VAS pain scale, including neuropathic pain
  • Major depressive disorder within 2 years before screening
  • Other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
  • Suicide attempt or suicidal behavior within 30 days before screening
  • Diagnosis of fibromyalgia
  • Considering total knee replacement in the next year
  • Any other condition, unwillingness, or inability that, in the investigator's opinion, could jeopardize the subject's safety or protocol compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GAE Arm
In this study, GAE is performed using the Lipiojoint technique described by Sapoval et al. This method utilizes a 3:1 emulsion of Lipiodol® (a transient embolic agent that penetrates distally to about 30 microns) and Optiray® to target the genicular arteries supplying areas of synovial hypervascularity and neo-angiogenesis. The embolic effect is temporary-lasting roughly 10 minutes-after which angiographic imaging shows resolution of the embolization with no damage to the surrounding skin, tendon, or bone. The endpoint of the procedure is to achieve complete stasis in the targeted vessels. 20 participants will be randomly allocated to this arm.
Procedure: Genicular Artery Embolization
Embolization of genicular arteries that demonstrate neoangiogenesis or blush on angiogram.
Other Names:
  • GAE
  • Geniculate Artery Embolization
Device: Lipiodol
3:1 emulsion of Lipiodol to Optiray
Procedure: Simple angiogram
Simple angiogram of the genicular arteries
Sham Comparator: Sham Arm
Participants assigned to the sham group undergo a similar preparatory process, including angiography and catheterization of all genicular arteries. However, no embolic agent is administered. Instead, after performing selective angiograms, these participants do not receive any embolization. 20 participants will be randomly allocated to this arm.
Procedure: Simple angiogram
Simple angiogram of the genicular arteries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in KOOS pain subscore
Time Frame: 3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC knee pain and dysfunction
Time Frame: 1, 3, 6, 9, and 12 months.
Reduction in knee pain and dysfunction (WOMAC) at 1, 3, 6, 9, and 12 months.
1, 3, 6, 9, and 12 months.
KOOS pain and dysfunction
Time Frame: 1, 3, 6, 9, and 12 months
Absolute reduction in knee pain and dysfunction (KOOS) at 1, 3, 6, 9, and 12 months
1, 3, 6, 9, and 12 months
VAS Score
Time Frame: 0, 1, 6, 9, and 12 months
Visual Analog Score (VAS) for pain at 0, 1, 6, 9, and 12 months post treatment
0, 1, 6, 9, and 12 months
Crossover
Time Frame: 3 months
Rate of cross-over from sham to GAE at 3 months
3 months
Analgesic Reduction
Time Frame: Baseline, 1, 3, 6, 9, and 12 months post intervention
Usage of opiate/analgesic medications at baseline, 1, 3, 6, 9, and 12 months post intervention
Baseline, 1, 3, 6, 9, and 12 months post intervention
Whole Knee Synovitis Scoring
Time Frame: Baseline and 3 months
Contrast Enhanced MRI with Whole Knee Synovitis Scoring at baseline and 3 months
Baseline and 3 months
Perfusion
Time Frame: Procedure
Perfusion quantification using pre and post embolization using CT-Perfusion scanning
Procedure
Knee replacement
Time Frame: 3 months
Rate of total knee replacement at 3 months
3 months
Corticosteroid injection usage
Time Frame: Baseline, 1, 3, 6, 9, and 12 months post intervention
Corticosteroid injection rate usage at baseline, 1, 3, 6, 9, and 12 months post intervention
Baseline, 1, 3, 6, 9, and 12 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

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

Investigators

  • Principal Investigator: Osman Ahmed, MD, University of Chicago Department of Radiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

February 23, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 5, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB24-1674
  • 1R21AR082123-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Will need to be considered on an individual basis given the desire to protect PHI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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