Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial

Description

Cooled radiofrequency ablation (cRFA) of the knee geniculate nerves is a promising treatment option for knee osteoarthritis, but has variable efficacy. Fluoroscopy is the typical guidance of choice, but uses bony landmarks to target these nerves which have variable positions around the knee. Alternatively, ultrasound allows for targeting based on visualization of bony landmarks, the nerves, and their accompanying vascular structures, and thus may offer greater accuracy. However, there are few studies which directly compare the clinical efficacy of these two guidance options. This study will compare these two options.

Conditions

Knee Osteoarthritis

Study Overview

Study Details

Study overview

Cooled radiofrequency ablation (cRFA) of the knee geniculate nerves is a promising treatment option for knee osteoarthritis, but has variable efficacy. Fluoroscopy is the typical guidance of choice, but uses bony landmarks to target these nerves which have variable positions around the knee. Alternatively, ultrasound allows for targeting based on visualization of bony landmarks, the nerves, and their accompanying vascular structures, and thus may offer greater accuracy. However, there are few studies which directly compare the clinical efficacy of these two guidance options. This study will compare these two options.

Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial

Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial

Condition
Knee Osteoarthritis
Intervention / Treatment

-

Contacts and Locations

Sacramento

UC Davis Health, Sacramento, California, United States, 95816

Rochester

University of Rochester, Rochester, New York, United States, 14627

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 1) patients of either gender with primary knee OA of one or both knees fulfilling the diagnostic criteria for knee OA by the American College of Rheumatology,
  • * 2) Kellgren-Lawrence score of two to four,
  • * 3) reported NPRS pain intensity of at least four on most or all days of the past week
  • * 4) pain resistant to conventional treatments which may include but is not limited to medications (e.g. acetaminophen, oral or topical non-steroidal anti-inflammatory drugs, opioids), physical therapy, and intra-articular injections (e.g. corticosteroids, hyaluronic acid, platelet-rich-plasma) for at least 3 months. In the case of bilateral knee OA, the most symptomatic knee will be treated and studied.
  • * 1) age \<35 years,
  • * 2) non-English speaking patients,
  • * 3) body mass index greater than 40,
  • * 4) previous radiofrequency ablation procedure for the knee,
  • * 5) active systemic or local infections at the site of needle/cRFA probe placement,
  • * 6) previous knee joint replacement surgery,
  • * 7) autoimmune or inflammatory cause of knee arthritis such as rheumatoid or psoriatic arthritis,
  • * 8) non-ambulatory patients,
  • * 9) patients who are unable to provide their own consent (e.g. dementia),
  • * 10) unstable medical or psychiatric illness,
  • * 11) patients with pacemakers, spinal cord stimulators, deep brain stimulators, or similar devices,
  • * 12) patients seeking care as a part of workman's compensation or have litigation pending
  • * 13) a negative response to diagnostic geniculate nerve lidocaine injections.

Ages Eligible for Study

35 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Davis,

Daniel Herman, MD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

2025-10-01