Bayer OA Knee Pain Pilot

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: Diagnostic Test: dynamic contrast enhanced MRI; Procedure: geniculate artery embolization

• Registration Number: NCT05349682
• Lead Sponsor: Medical University of South Carolina

Brief Summary

The objective of this study is to investigate if MRI can be used to evaluated effect of knee artery embolization for knee osteoarthritis. Participants be evaluated in clinic, obtain a knee MRI, undergo embolization of the symptomatic knee, and follow up in clinic at 1, 6, and 12 months after embolization. A second MRI is obtained 6 months after embolization. Participants will keep a record of their pain level and treatment and answer questionnaires at each visit.

In addition, this study aims to determine the effects of knee artery embolization on the amount of opioid (pain reliever drugs) needed to manage osteoarthritis-associated pain and change in quality of life.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-27
• Study Start: 2022-10-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Age 25 to 90
2. Symptomatic osteoarthritis of one or both knees, with Kellgren-Lawrence grade 1-3 assessed by weight-bearing knee radiography, including post-traumatic osteoarthritis
3. One or more months of non-surgical therapy for knee pain such as joint injections, oral NSAIDs, or opioid analgesia
4. Subjects able to provide informed consent. As this is a study of pain, patients must be able to consent for themselves.
5. Patients without contraindication to MRI imaging with gadolinium-based contrast.

Exclusion Criteria

1. Anaphylaxis to gadolinium or iodinated contrast media
2. Impaired renal function with GFR <30ml/min
3. Severe atherosclerotic disease of the lower extremity precluding percutaneous angiographic access to the involved geniculate artery(ies)
4. Active septic arthritis of the symptomatic knee within 2 months of screening
5. Malignancy of the involved knee
6. Rheumatoid Arthritis or Gout
7. Prior knee surgery
8. Hemarthrosis
9. Females who are pregnant or plan to become pregnant during the study. All participants able to become pregnant will be administered a urine pregnancy test.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GAE and MRI treatment arm	dynamic contrast enhanced MRI	GAE is geniculate artery embolization.
GAE and MRI treatment arm	geniculate artery embolization	GAE is geniculate artery embolization.

Primary Outcome Measures

Name	Time	Method
Number of participants with 50% reduction in pain scores	change from baseline at 12 month post procedure	To determine the effects of geniculate artery embolization (GAE) on opioid requirements for managing OA associated pain. Assess pain using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score (KOOS). WOMAC is scored from 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. Higher scores indicate worse pain, stiffness, and function limitation. KOOS score is from 0-100, 0 being extreme problems and 100 being no problems.
Incidence of adverse events associated with GAE	12 month post procedure	The number of adverse events per participant
Change in Whole-Organ Magnetic Resonance Scoring (WORMS)	change from baseline at 6 month post procedure	To evaluate the effects of particle embolization on knee osteoarthritis progression using the WORMS scoring system. The higher the score, the worse the OA is. The scoring ranges from 0-332.
Change in enhancement time intensity curves obtained from CE-MRI	change from baseline at 6 month post procedure	To evaluate the effects of particle embolization on knee osteoarthritis progression using enhancement time intensity curves obtained from CE-MRI (Contrast Enhanced Magnetic Resonance Imaging)
Change in Multicenter Osteoarthritis Study (MOST) grading system for synovitis	change from baseline at 6 month post procedure	To evaluate the effects of particle embolization on knee osteoarthritis progression using the MOST grading system for synovitis. The higher the score, the worse the synovial inflammation is. The scoring ranges from 0-13. 0-4 normal or equivocal synovitis, 5-8 mild synovitis, 9-12 moderate synovitis, and 13 or greater is severe synovitis.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States