RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-02

Study Completion:2025-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04472702

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Daniel Herman, MD

CONTACT

916-734-6805

dcherman@ucdavis.edu

Katherine Rizzone, MD

CONTACT

585-341-9407

katherine_rizzone@urmc.rochester.edu

Principal Investigator

Daniel Herman, MD

PRINCIPAL_INVESTIGATOR

University of California, Davis

Study Locations (Sites)

UC Davis Health

Sacramento, California, 95816

United States

University of Rochester

Rochester, New York, 14627

United States

Collaborators and Investigators

Sponsor: University of California, Davis

Daniel Herman, MD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-02

Study Completion Date2025-10-01

Study Record Updates

Study Start Date2022-02-02

Study Completion Date2025-10-01

Terms related to this study

Additional Relevant MeSH Terms

Knee Osteoarthritis