RecruitingNot ApplicableNCT04472702

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

Sponsor

University of California, Davis

Enrollment

90 participants

Start Date

Feb 2, 2022

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis

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

Min Age: 35 YearsMax Age: 99 Years

Inclusion Criteria4

\) 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,
\) Kellgren-Lawrence score of two to four,
\) reported NPRS pain intensity of at least four on most or all days of the past week
\) 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 Criteria13

\) age <35 years,
\) non-English speaking patients,
\) body mass index greater than 40,
\) previous radiofrequency ablation procedure for the knee,
\) active systemic or local infections at the site of needle/cRFA probe placement,
\) previous knee joint replacement surgery,
\) autoimmune or inflammatory cause of knee arthritis such as rheumatoid or psoriatic arthritis,
\) non-ambulatory patients,
\) patients who are unable to provide their own consent (e.g. dementia),
\) unstable medical or psychiatric illness,
\) patients with pacemakers, spinal cord stimulators, deep brain stimulators, or similar devices,
\) patients seeking care as a part of workman's compensation or have litigation pending
\) a negative response to diagnostic geniculate nerve lidocaine injections.

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Interventions

PROCEDUREcRFA

cRFA intervention will occur under sterile conditions, the patient will be placed in a supine position on a table and a bolster to provide flexion in the treated knee joint. Skin and soft tissues will be anaesthetized with 2 mL 1% lidocaine at each of the three anatomic sites for cRFA, and a introducer needle will then be placed under ultrasound or fluoroscopic guidance to the SLG, SMG, and IMG nerves. Adjustments at these positions will be made when using ultrasound guidance in order to capture the geniculate nerve if the nerve and/or its accompanying vasculature can be directly visualized using greyscale or Doppler modes. When using ultrasound, the physician will note and record whether their positioning of the needle is based on bony landmarks, direct visualization of the nerve, and/or vascularity accompanying the nerve. Once the introducer needle is placed, the cRFA will be placed into the introducer needle.