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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment cooled radiofrequency ablation (CRFA) for knee osteoarthritis?

Research shows that cooled radiofrequency ablation (CRFA) is effective in reducing knee pain caused by osteoarthritis, with studies demonstrating greater pain relief and improved function compared to other treatments like hyaluronic acid injections. Patients have reported satisfactory outcomes and long-term benefits, with no major safety concerns identified. ^{1 2 3 4 5}

Is cooled radiofrequency ablation (cRFA) safe for treating knee osteoarthritis?

Research shows that cooled radiofrequency ablation (cRFA) is generally safe for treating knee osteoarthritis, with studies reporting no significant safety concerns and satisfactory outcomes for most patients. ^{1 2 4 5 6}

How is the treatment cRFA different from other treatments for knee osteoarthritis?

Cooled Radiofrequency Ablation (cRFA) is a minimally invasive treatment that uses cooled radiofrequency energy to target and disrupt nerve signals responsible for knee pain, providing longer-lasting relief compared to short-term options like hyaluronic acid injections. It is unique because it can be guided by ultrasound, offering a non-surgical alternative with satisfactory pain relief and functional improvement. ^{1 2 3 4 5}

Research Team

Daniel Herman, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided cooled radiofrequency ablation of the genicular nerves: a technique paper. [2021]

2. England 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Long-Term Retrospective Assessment of Clinical Efficacy of Radiofrequency Ablation of the Knee Using a Cooled Radiofrequency System. [2020]

4. United States 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. [2021]

5. United States 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. [2020]

6. England 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. [2022]