cRFA Guidance Techniques for Knee Osteoarthritis

Recruiting at 2 trial locations

Overseen By Dan Herman, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Age <35, BMI >40, Infections, Autoimmune arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to guide a treatment called cooled radiofrequency ablation (cRFA) for individuals with knee osteoarthritis (OA). cRFA uses heat to target and relieve pain by focusing on specific nerves in the knee. The study compares fluoroscopy, which relies on bone landmarks, with ultrasound, which can directly visualize the nerves, to determine which method is more effective. Participants should have knee OA that hasn't improved with standard treatments like medications or physical therapy and should have experienced significant pain relief from specific nerve block tests. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance pain management techniques for knee OA.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial is for patients whose pain is resistant to conventional treatments, it seems likely that you can continue your current medications.

What prior data suggests that these guidance techniques for cRFA are safe for knee osteoarthritis?

Research has shown that cooled radiofrequency ablation (cRFA) safely treats knee osteoarthritis (OA) pain. Studies indicate that patients tolerate cRFA well, whether performed with X-ray or ultrasound guidance. The procedure targets specific nerves in the knee to reduce pain.

Few reports of serious side effects exist. cRFA is minimally invasive, requiring neither large incisions nor lengthy recovery time. This makes it a suitable option for those seeking knee OA pain relief without major surgery.

In summary, research supports cRFA as a safe treatment for knee OA, with both X-ray and ultrasound guidance proving effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for knee osteoarthritis because they explore different guidance techniques for delivering cooled radiofrequency ablation (cRFA). Unlike traditional treatments like NSAIDs or corticosteroid injections, cRFA targets the nerve pain directly by using heat to disrupt nerve function, potentially offering longer-lasting pain relief. In this trial, two methods are being compared: fluoroscopy and ultrasound guidance. The use of imaging techniques like fluoroscopy and ultrasound aims to enhance precision in targeting the nerves, which could improve the effectiveness and safety of the treatment. By comparing these two guidance methods, researchers hope to determine the most effective approach, potentially transforming pain management for knee osteoarthritis patients.

What evidence suggests that these guidance techniques for cRFA could be effective for knee osteoarthritis?

Research has shown that cooled radiofrequency ablation (cRFA) effectively treats knee osteoarthritis (OA) by targeting the genicular nerves, significantly reducing pain. Studies indicate that cRFA provides more pain relief than placebo treatments. In this trial, participants will be randomized into two treatment arms: one using fluoroscopy and the other using ultrasound to guide the cRFA procedure. Fluoroscopy uses X-rays to locate the nerves, while ultrasound employs sound waves for more precise targeting. Some studies suggest ultrasound may be more accurate because it can directly show the nerves and nearby blood vessels. Both techniques have demonstrated promising results in reducing pain and improving quality of life for people with knee OA. ^{1 2 6 7 8}

Who Is on the Research Team?

Daniel Herman, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for adults with knee osteoarthritis who have pain most days of the week and haven't found relief from standard treatments like medications or physical therapy. They should have a Kellgren-Lawrence score of 2-4, indicating moderate to severe arthritis. It's not for those under 35, very overweight individuals (BMI over 40), those with previous knee surgeries or certain medical devices, non-English speakers, or anyone unable to consent.

Inclusion Criteria

My knee pain hasn't improved with standard treatments for over 3 months.

I have been diagnosed with knee osteoarthritis by the American College of Rheumatology standards.

Kellgren-Lawrence score of two to four

Exclusion Criteria

I have had a radiofrequency ablation procedure on my knee.

I have had knee replacement surgery.

I am unable to give my own consent due to a condition like dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cooled radiofrequency ablation (cRFA) of the knee geniculate nerves using either fluoroscopic or ultrasound guidance

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at one month, three months, and six months

6 months

3 visits (in-person or phone contact)

Long-term Follow-up

Participants' pain levels and functional status are monitored up to 24 months

18 months

What Are the Treatments Tested in This Trial?

Interventions

• cRFA

Trial Overview

The study tests whether using ultrasound guidance improves the accuracy and effectiveness of cooled radiofrequency ablation (cRFA) compared to traditional fluoroscopy guidance in treating geniculate nerve pain in knee osteoarthritis patients.

How Is the Trial Designed?

Group I: Subjects with knee OA using ultrasound for cRFA intervention Experimental Treatment 1 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 II: Subjects with knee OA using fluoroscopy for cRFA intervention Experimental Treatment 1 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.

cRFA is already approved in United States, European Union for the following indications:

Approved in United States as Cooled Radiofrequency Ablation for:

• Knee osteoarthritis pain

Approved in European Union as Cooled Radiofrequency Ablation for:

• Chronic knee pain due to osteoarthritis

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

American Medical Society for Sports Medicine Collaborative Research Network

Collaborator

Trials

1

Recruited

90+

Published Research Related to This Trial

Cooled radiofrequency ablation (CRFA) using ultrasound guidance was successfully performed on 51 patients, with 22 providing feedback through a telephone survey, showing no safety concerns.

Most patients reported satisfactory outcomes, indicating that US-guided CRFA can effectively relieve pain and improve function in those suffering from knee pain due to osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided cooled radiofrequency ablation of the genicular nerves: a technique paper. Lash, D., Frantz, E., Hurdle, MF.[2021]

In a study involving 175 subjects with knee osteoarthritis, cooled radiofrequency ablation (CRFA) resulted in a significantly greater reduction in pain (71% achieving ≥50% pain relief) compared to a single hyaluronic acid (HA) injection (38% achieving the same), indicating CRFA's superior efficacy.

Both treatments were found to have similar safety profiles, with no serious adverse events reported, suggesting that CRFA is a safe and effective alternative to HA injections for managing knee osteoarthritis pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cooled Radiofrequency Ablation Compared with a Single Injection of Hyaluronic Acid for Chronic Knee Pain: A Multicenter, Randomized Clinical Trial Demonstrating Greater Efficacy and Equivalent Safety for Cooled Radiofrequency Ablation. Chen, AF., Khalouf, F., Zora, K., et al.[2021]

Cooled radiofrequency ablation (CRFA) demonstrated sustained pain relief and improved knee function in patients with osteoarthritis over a 24-month period, with 12 out of 25 subjects reporting at least 50% pain relief at 18 months and 11 out of 18 at 24 months.

The study, which included 33 subjects from a larger randomized trial, showed significant functional improvement as measured by the Oxford Knee Score, with an overall mean change of 26.0 points at 18 months and 29.9 points at 24 months, and no safety concerns were identified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cooled Radiofrequency Ablation Treatment of the Genicular Nerves in the Treatment of Osteoarthritic Knee Pain: 18- and 24-Month Results. Hunter, C., Davis, T., Loudermilk, E., et al.[2020]

Cooled radiofrequency ablation (CRFA) significantly outperformed intra-articular steroid (IAS) injections in reducing knee pain and improving function in patients with osteoarthritis, with 74.1% of CRFA patients experiencing a 50% or greater pain reduction at 6 months compared to only 16.2% in the IAS group.

The study, involving 151 subjects with chronic knee pain, found no serious adverse events related to CRFA, indicating it is a safe long-term treatment option for managing osteoarthritis-related knee pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Davis, T., Loudermilk, E., DePalma, M., et al.[2022]

Cooled radiofrequency ablation (CRFA) provided significant pain relief for patients with knee osteoarthritis, with 65% of patients experiencing at least a 50% reduction in pain 12 months after the procedure.

The study also showed that CRFA was effective for patients who had unsatisfactory results from intra-articular steroid injections, with no unexpected adverse events reported, indicating a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-month analgesia and rescue, by cooled radiofrequency ablation treatment of osteoarthritic knee pain: results from a prospective, multicenter, randomized, cross-over trial. Davis, T., Loudermilk, E., DePalma, M., et al.[2019]

Cooled radiofrequency ablation (CRFA) was effective in providing long-term pain relief for chronic knee pain, with 65% of patients reporting over 50% pain relief and 14% experiencing complete pain relief after the procedure.

The average duration of significant pain relief after CRFA was 12.5 months, and the treatment was effective even for patients who had persistent pain after total knee arthroplasty, indicating its potential as a viable option for managing chronic knee pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Retrospective Assessment of Clinical Efficacy of Radiofrequency Ablation of the Knee Using a Cooled Radiofrequency System. Kapural, L., Lee, N., Neal, K., et al.[2020]

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