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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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, 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
UC Davis Health
NOT_YET_RECRUITING
Sacramento
New York
University of Rochester
RECRUITING
Rochester
Contact Information
Primary
Daniel Herman, MD
dcherman@ucdavis.edu
916-734-6805
Backup
Katherine Rizzone, MD
katherine_rizzone@urmc.rochester.edu
585-341-9407
Time Frame
Start Date: 2022-02-02
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 90
Treatments
Experimental: Subjects with knee OA using ultrasound for cRFA intervention
Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to ultrasound (N=45) cRFA treatment arm.
Experimental: Subjects with knee OA using fluoroscopy for cRFA intervention
Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to fluoroscopic (N=45) cRFA treatment arm.
Authors
Dan Herman
Related Therapeutic Areas
Sponsors
Collaborators: American Medical Society for Sports Medicine Collaborative Research Network
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov