Clinical trial NCT05349682: Bayer OA Knee Pain Pilot
Official title: Transcatheter Geniculate Arterial Embolization: Treatment and Monitoring of Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2022-04-27
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in enhancement time intensity curves obtained from CE-MRI
timeFrame: change from baseline at 6 month post procedure
measure: Change in Whole-Organ Magnetic Resonance Scoring (WORMS)
timeFrame: change from baseline at 6 month post procedure
measure: Change in Multicenter Osteoarthritis Study (MOST) grading system for synovitis
timeFrame: change from baseline at 6 month post procedure
measure: Number of participants with 50% reduction in pain scores
timeFrame: change from baseline at 1 month post procedure
measure: Number of participants with 50% reduction in pain scores
timeFrame: change from baseline at 6 month post procedure
measure: Number of participants with 50% reduction in pain scores
timeFrame: change from baseline at 12 month post procedure
measure: Incidence of adverse events associated with GAE
timeFrame: 1 month post procedure
measure: Incidence of adverse events associated with GAE
timeFrame: 6 month post procedure
measure: Incidence of adverse events associated with GAE
timeFrame: 12 month post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Andre Uflacker, MD
role: PRINCIPAL_INVESTIGATOR
References: