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Bayer OA Knee Pain Pilot

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dynamic contrast enhanced MRI
geniculate artery embolization
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

25 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GAE and MRI treatment arm

Arm Description

GAE is geniculate artery embolization.

Outcomes

Primary Outcome Measures

Change in enhancement time intensity curves obtained from CE-MRI
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 Whole-Organ Magnetic Resonance Scoring (WORMS)
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 Multicenter Osteoarthritis Study (MOST) grading system for synovitis
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.
Number of participants with 50% reduction in pain scores
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.
Number of participants with 50% reduction in pain scores
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.
Number of participants with 50% reduction in pain scores
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
The number of adverse events per participant
Incidence of adverse events associated with GAE
The number of adverse events per participant
Incidence of adverse events associated with GAE
The number of adverse events per participant

Secondary Outcome Measures

Full Information

First Posted
March 28, 2022
Last Updated
November 1, 2022
Sponsor
Medical University of South Carolina
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT05349682
Brief Title
Bayer OA Knee Pain Pilot
Official Title
Transcatheter Geniculate Arterial Embolization: Treatment and Monitoring of Response
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GAE and MRI treatment arm
Arm Type
Experimental
Arm Description
GAE is geniculate artery embolization.
Intervention Type
Diagnostic Test
Intervention Name(s)
dynamic contrast enhanced MRI
Intervention Description
An MRI study of the knee will be done to check the degree of osteoarthritis and blood flow to the affected knee. This scan will take about 1-2 hour(s).
Intervention Type
Procedure
Intervention Name(s)
geniculate artery embolization
Intervention Description
The physician will perform a diagnostic angiography, where they will take pictures of vessels near the knee that will be treated. Once the artery to be treated is identified, the doctor will guide a thin wire called a microwire, and a plastic tube called a microcatheter to the targeted artery, and more pictures of vessels at the knee will be taken. This picture will be used to see if there are any abnormal vessels at the knee, such as abnormal blood flow, abnormal vessel connections (between the veins and arteries), or new blood vessel growth. Once the targeted artery at the knee is confirmed, the doctor will inject enough particle embolic (Embozene) to slow or stop the blood flow in the geniculate artery. Once all vessels are treated, a final angiogram (pictures of blood vessels) will be performed to ensure that the blood flow has slowed.
Primary Outcome Measure Information:
Title
Change in enhancement time intensity curves obtained from CE-MRI
Description
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)
Time Frame
change from baseline at 6 month post procedure
Title
Change in Whole-Organ Magnetic Resonance Scoring (WORMS)
Description
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.
Time Frame
change from baseline at 6 month post procedure
Title
Change in Multicenter Osteoarthritis Study (MOST) grading system for synovitis
Description
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.
Time Frame
change from baseline at 6 month post procedure
Title
Number of participants with 50% reduction in pain scores
Description
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.
Time Frame
change from baseline at 1 month post procedure
Title
Number of participants with 50% reduction in pain scores
Description
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.
Time Frame
change from baseline at 6 month post procedure
Title
Number of participants with 50% reduction in pain scores
Description
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.
Time Frame
change from baseline at 12 month post procedure
Title
Incidence of adverse events associated with GAE
Description
The number of adverse events per participant
Time Frame
1 month post procedure
Title
Incidence of adverse events associated with GAE
Description
The number of adverse events per participant
Time Frame
6 month post procedure
Title
Incidence of adverse events associated with GAE
Description
The number of adverse events per participant
Time Frame
12 month post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 25 to 90 Symptomatic osteoarthritis of one or both knees, with Kellgren-Lawrence grade 1-3 assessed by weight-bearing knee radiography, including post-traumatic osteoarthritis One or more months of non-surgical therapy for knee pain such as joint injections, oral NSAIDs, or opioid analgesia Subjects able to provide informed consent. As this is a study of pain, patients must be able to consent for themselves. Patients without contraindication to MRI imaging with gadolinium-based contrast. Exclusion Criteria: Anaphylaxis to gadolinium or iodinated contrast media Impaired renal function with GFR <30ml/min Severe atherosclerotic disease of the lower extremity precluding percutaneous angiographic access to the involved geniculate artery(ies) Active septic arthritis of the symptomatic knee within 2 months of screening Malignancy of the involved knee Rheumatoid Arthritis or Gout Prior knee surgery Hemarthrosis 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel Bidwell
Phone
843-792-2305
Email
bidwells@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre Uflacker, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Bidwell
Phone
843-792-2305
Email
bidwells@musc.edu
First Name & Middle Initial & Last Name & Degree
Andre Uflacker, MD
Phone
843-876-3185
Email
uflackera@musc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study team will share anonymized DCE-MRI data with consulting radiologists.
IPD Sharing Time Frame
duration of the study
IPD Sharing Access Criteria
The data will only be shared via encrypted email or encrypted cloud repository.

Learn more about this trial

Bayer OA Knee Pain Pilot

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