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

NCT ID: NCT04472702

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2026-01-01

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, 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.

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 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. Objective: To compare the effectiveness of geniculate nerve cRFA on knee osteoarthritis outcomes when using either ultrasound or fluoroscopic guidance. The primary outcome measures will be patient pain levels and patient-reported function. The secondary outcome measures will be objective performance-based functional outcomes. The exploratory outcome measures will be blood biomarkers of inflammation, extracellular matrix turnover, and cartilage degradation. Methods: 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) or ultrasound (N=45) cRFA treatment arms. Baseline assessments will include 1) Numeric Pain Rating Scale, Western Ontario and McMaster Universities Osteoarthritis Index, and PROMIS depression and pain interference measures; 2) the Osteoarthritis Research Society International recommended physical performance assessments including the 30-Second Chair Stand Test, Stair Climb Test, 40m Fast Paced Walk Test, Timed Up and Go Test, and Six Minute Walk Test; and 3) in a subset of patients (N=24), blood biomarkers including MMP-3, IL-1β, TNF-α, COMP, and CTX-II. These measures will be re-assessed at one month (pain and patient-reported function only, via phone contact), three months, and 6 months after the cRFA procedure. Study endpoints will be assessed using a mixed model repeated measures analysis of variance using an alpha level of 0.05. Statement of Relevance: Knee osteoarthritis patients are commonly treated by sports medicine providers, who are typically well-trained in the use of ultrasound. Should ultrasound be demonstrated as effective for cRFA, sports medicine providers would be well-positioned to use relatively low-cost and accessible imaging technology to significantly improve patient pain and function using cRFA.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

cRFA

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

cRFA

Intervention Type: PROCEDURE

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.

Interventions

cRFA

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Medical Society for Sports Medicine Collaborative Research Network

UNKNOWN

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Herman, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

UC Davis Health

Sacramento, California, United States

Site Status: NOT_YET_RECRUITING

University of Rochester

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel Herman, MD

Role: CONTACT

dcherman@ucdavis.edu

916-734-6805

Katherine Rizzone, MD

Role: CONTACT

katherine_rizzone@urmc.rochester.edu

585-341-9407

Facility Contacts

Daniel Herman, MD

Role: primary

dcherman@ucdavis.edu

916-734-6805

Katherine Rizzone, MD

Role: primary

katherine_rizzone@urmc.rochester.edu

585-341-9407

Other Identifiers

STUDY00005460

Identifier Type: OTHER

Identifier Source: secondary_id

1868999

Identifier Type: -

Identifier Source: org_study_id