Status:
RECRUITING
Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
American Medical Society for Sports Medicine Collaborative Research Network
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
35-99 years
Phase:
NA
Brief Summary
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, b...
Detailed Description
Background: 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04472702
Start Date
February 2 2022
End Date
January 1 2026
Last Update
December 17 2025
Active Locations (2)
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1
UC Davis Health
Sacramento, California, United States, 95816
2
University of Rochester
Rochester, New York, United States, 14627