Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: the Terumo Hydropearl® microspheres device

• Registration Number: NCT04592562
• Lead Sponsor: University of Chicago

Brief Summary

The goal of this study is to perform a feasibility study to show the effectiveness of the genicular artery embolization procedure in reducing bilateral or unilateral osteoarthritic knee pain at 12 months as measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, Knee Injury and Osteoarthritis Outcome (KOOS) score, and Oswestry Disability Index.

Detailed Description

This is a single-center, pilot study to assess the feasibility of a study show the effectiveness of the genicular artery embolization (GAE) in reducing arthritic pain and dysfunction associated with mild to moderate Bilateral or unilateral osteoarthritis of the knee. Patients with bilateral or unilateral Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale, will be offered enrollment to the study. Following a screening questionnaire, these patients will then be enrolled in this study. Baseline MRI will be obtained prior to the GAE procedure. Follow up intervals will include 3, 6, 9, and 12 months with the primary objective measured by a clinician as the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, Knee Injury and Osteoarthritis Outcome (KOOS) score, and Oswestry Disability Index at the 12-month follow up visit. Patients will also undergo 1 year follow up MRI to be interpreted by a diagnostic radiologist with subspecialty training in musculoskeletal radiology. This radiologist will compare the treated knee to the baseline screening according to the WORMS classification (Whole Organ Magnetic Resonance Scoring) to assess for radiologic changes of osteoarthritis and any adverse effects.

Study Timeline

• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-19
• Study Start: 2021-09-22
• Status Verified: 2024-05
• Primary Completion: 2024-05-28
• Study Completion: 2024-05-28
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

We intend to include patients who meet the following criteria in the study:

1. Patients aged 40-80
2. Bilateral or Unilateral knee pain attributed to osteoarthritis
3. Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale
4. Knee pain >6 months refractory to conservative medical management (NSAIDs, paracetamol, intra-articular injections, physiotherapy/exercise, weight loss, etc.)

Exclusion Criteria

• We plan to exclude patients who meet any of the following criteria:

  1. Active malignancy
  2. Active infection of the affected knee
  3. Platelets <50,000
  4. INR >1.8 (unless on anticoagulation that can be reversed)
  5. Corticosteroid injection of the affected knee within 3 months
  6. Rheumatoid arthritis or other seronegative arthropathy
  7. Previous surgery (excluding arthroscopy) of the affected knee
  8. Grade 4 per Kellgren-Lawrence Grading Scale of the affected knee
  9. Pregnancy or expected pregnancy
  10. GFR <30
  11. Anaphylactic reaction to iodinated contrast
  12. Moderate to severe pain in other lower limb joints
  13. Body weight >400 lbs. (Procedure table weight limit)
  14. BMI >50
  15. Patients at high risk for contrast nephropathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GAE Arm	the Terumo Hydropearl® microspheres device	Patients who meet study eligibility will be scheduled to undergo the Genicular Artery Embolization procedure and will subsequent be followed for 12 months after their procedure.

Primary Outcome Measures

Name	Time	Method
WOMAC Scale	12 Months	The reduction of Bilateral or unilateral knee pain and dysfunction associated with mild to moderate osteoarthritis at 12 months as measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score
KOOS Scale	12 Months	The reduction of Bilateral or unilateral knee pain and dysfunction associated with mild to moderate osteoarthritis at 12 months as measured by the Knee Injury and Osteoarthritis Outcome (KOOS) score
Oswestry Disability Index	12 Months	The reduction of Bilateral or unilateral knee pain and dysfunction associated with mild to moderate osteoarthritis at 12 months as measured by the Oswestry Disability Index

Secondary Outcome Measures

Name	Time	Method
WOMAC for Knee Pain and Dysfunction	12 Months	To assess reduction in knee pain and dysfunction at 3, 6, and 9-months for subjects undergoing the GAE procedure using the WOMAC scale
KOOS for Knee Pain and Dysfunction	12 Months	To assess reduction in knee pain and dysfunction at 3, 6, and 9-months for subjects undergoing the GAE procedure using the KOOS scale
Oswestry Disability Index for Knee Pain and Dysfunction	12 Months	To assess reduction in knee pain and dysfunction at 3, 6, and 9-months for subjects undergoing the GAE procedure using the Oswestry Disability Index
Six-Minute Walk Test for Functional Improvement	12 months	To determine and report six-minute walk test performance and to assess functional improvement at baseline, 3, 6, 9, and 12 months
Thirty-Second Chair Test for Performance	12 Months	To determine and report thirty-second chair stand test performances and to assess functional improvement at baseline, 3, 6, 9, and 12 months.
VAS for Pain	12 Months	To report the outcomes of Visual Analog Score (VAS) for pain at 0, 3, 6, 9, and 12 months post.
Opiate Usage	12 Months	Change in usage of opiate or opiate-equivalent medications calculated by using the internal opioid change log, kept and updated by the study team from baseline to 12 months

Trial Locations

Locations (1)

University of Chicago Hospital; 🇺🇸 Chicago, Illinois, United States