RECRUITING

Bayer OA Knee Pain Pilot

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Conditions

Osteoarthritis, Knee

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Transcatheter Geniculate Arterial Embolization: Treatment and Monitoring of Response

Quick Facts

Study Start:2022-10-01
Study Completion:2024-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05349682

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.

Ages Eligible for Study:25 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 25 to 90
  2. 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. 3. One or more months of non-surgical therapy for knee pain such as joint injections, oral NSAIDs, or opioid analgesia
  4. 4. Subjects able to provide informed consent. As this is a study of pain, patients must be able to consent for themselves.
  5. 5. Patients without contraindication to MRI imaging with gadolinium-based contrast.
  1. 1. Anaphylaxis to gadolinium or iodinated contrast media
  2. 2. Impaired renal function with GFR \<30ml/min
  3. 3. Severe atherosclerotic disease of the lower extremity precluding percutaneous angiographic access to the involved geniculate artery(ies)
  4. 4. Active septic arthritis of the symptomatic knee within 2 months of screening
  5. 5. Malignancy of the involved knee
  6. 6. Rheumatoid Arthritis or Gout
  7. 7. Prior knee surgery
  8. 8. Hemarthrosis
  9. 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.

Contacts and Locations

Study Contact

Samuel Bidwell
CONTACT
843-792-2305
bidwells@musc.edu

Principal Investigator

Andre Uflacker, MD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Andre Uflacker, MD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

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 Registration Dates

Study Start Date2022-10-01
Study Completion Date2024-11

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2024-11

Terms related to this study

Additional Relevant MeSH Terms

  • Osteoarthritis, Knee