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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT04472702
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • cRFA — 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.

Study Details

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.

Key Dates

Start date
Feb 2, 2022
Status verified
Feb 2026
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Numeric Pain Rating Scale [ Time Frame: Baseline up to 24 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UC Davis HealthSacramentoCalifornia95816
Daniel Herman, MD
[email protected]
916-734-6805
Daniel Herman, MD (PRINCIPAL_INVESTIGATOR)
University of RochesterRochesterNew York14627
Katherine Rizzone, MD
[email protected]
585-341-9407
Katherine Rizzone, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
UC Davis Health· Sacramento, CAUniversity of Rochester· Rochester, NY

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