Radiofrequency Ablation for Osteoarthritis Post-Knee Replacement

(GRATKA Trial)

Overseen By Jennifer Laxshimalla

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Infection, Prosthetic failure, Severe psychiatric disorder, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

44 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for those whose pain is not relieved by conventional treatments like medication, you might be able to continue them. It's best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment Genicular Radiofrequency Ablation for knee pain after knee replacement?

Research shows that genicular nerve radiofrequency ablation is effective in reducing chronic knee pain related to osteoarthritis, especially when other treatments have failed. It has been successfully used to alleviate pain after total knee replacement, providing relief for patients who experience persistent pain. ^{1 2 3 4 5}

Is genicular nerve radiofrequency ablation safe for humans?

Genicular nerve radiofrequency ablation (GNRFA) is considered a safe treatment for reducing knee pain in people with osteoarthritis, with studies showing it can decrease pain and improve function without increasing the risk of complications after knee replacement surgery. ^{1 2 4 6 7}

How is the treatment Genicular Radiofrequency Ablation different from other treatments for knee pain after replacement surgery?

Genicular Radiofrequency Ablation (GNRFA) is unique because it targets specific nerves around the knee to reduce pain, especially when other treatments haven't worked. It uses heat to disrupt pain signals and is often used when surgery isn't an option or hasn't relieved pain. ^{1 2 6 8 9}

What is the purpose of this trial?

Currently, nearly 1 million total knee arthroplasties (TKA) are performed yearly in the United States. Three million are projected to be performed in 2040. Between 15-30% of all patients who undergo TKA have continued pain, reduced quality of life and functional impairments that cannot be attributed to hardware failure/loosening or infection. Treatment options for persistent post TKA pain (failed TKA) are limited. There is a need for minimally invasive, and effective pain and disability modulating interventions for patients with failed TKA. Genicular radiofrequency ablation (GRFA) has been described, refined, and validated as an effective minimally invasive intervention to control refractory knee pain secondary to knee osteoarthritis (OA) as evidenced by three favorable meta-analyses published in 2021 alone.3-5 GRFA is a minimally invasive percutaneous procedure that utilizes thermal energy to coagulate nerves from the knee. Though sometimes used in practice, there is limited research describing and evaluating GRFA for patients with failed TKA. This will be the first trial to evaluate the safety and efficacy of GRFA in patients with failed TKA using a robust study design and up-to-date, evidence-based selection criteria and technique.

Research Team

Ashley Smith, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for individuals who had knee replacement surgery at least a year ago and still experience significant pain (more than 4/10) despite treatments like physiotherapy or medication. They must have had major pain relief from a specific diagnostic nerve block. Exclusions include uncontrolled bleeding disorders, pregnancy, severe psychiatric conditions, pacemakers, certain allergies, and other specific medical issues.

Inclusion Criteria

I experienced significant pain relief from a specific nerve block procedure.

My condition did not improve with standard treatments like physiotherapy or medication.

It has been over a year since my knee replacement surgery.

Exclusion Criteria

Prosthetic loosening or failure, periprosthetic fracture

I have leg pain from poor blood flow when I walk.

I do not have a condition that causes uncontrolled bleeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either thermal or sham genicular radiofrequency ablation (GRFA) for knee pain management

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, and 12 months post-GRFA

12 months

3 visits (in-person)

Crossover

Participants in the sham group are offered crossover to receive the active GRFA treatment

6 months post-treatment

Treatment Details

Interventions

• Genicular Radiofrequency Ablation
• Sham Genicular Radiofrequency Ablation

Trial Overview The study tests Genicular Radiofrequency Ablation (GRFA), which uses heat to disrupt nerves causing knee pain after total knee arthroplasty (TKA). It's compared against a sham procedure to assess its safety and effectiveness in reducing persistent post-TKA pain using evidence-based techniques.

Participant Groups

Group I: Group 1 (GRFA) Experimental Treatment 1 Intervention

After the cannulae are placed and tines deployed, a single lesion (30 second ramp-up time; 80C x 2 minutes) will be made at each of the medial and lateral branches of the nerve to the vastus intermedialis, nerves to the vastus lateralis and medialis, recurrent fibular nerve, inferior medial genicular nerve. One bipolar strip lesion (intercannula distance 1.5 cm; anticipated strip lesion length 2.0 cm) at the superior medial and lateral genicular nerves will be made to accommodate anatomical variability.

Group II: Group 2 (Sham) Active Control 1 Intervention

The same procedure will be employed as per Group 1 - However, the sham procedure will involve no electrical signal applied to the participant.

Genicular Radiofrequency Ablation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Genicular Radiofrequency Ablation for:

• Chronic knee pain due to osteoarthritis
• Failed total knee arthroplasty

Approved in European Union as Genicular Nerve Ablation for:

• Chronic knee pain due to osteoarthritis

Approved in Canada as Genicular Neurotomy for:

• Chronic knee pain due to osteoarthritis

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Findings from Research

Genicular nerve radiofrequency ablation is a treatment option for patients with osteoarthritic knee pain who do not respond to conservative or minimally invasive treatments.

The article discusses the procedure's effectiveness, patient selection criteria, and potential risks and complications, highlighting its role in managing chronic knee pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genicular nerve radiofrequency ablation: An option for knee osteoarthritis pain. Swanson, JL.[2023]

Genicular nerve radiofrequency ablation (GNRFA) is an effective treatment for chronic knee pain due to osteoarthritis, particularly for patients who cannot undergo surgery or have not found relief from conservative treatments.

The proposed image-guided technique for targeting the infrapatellar branch of the saphenous nerve aims to enhance the efficacy of GNRFA while addressing safety concerns, such as avoiding damage to surrounding tissues, though further clinical research is needed to validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency Ablation of the Infrapatellar Branch of the Saphenous Nerve for the Treatment of Chronic Anterior Inferomedial Knee Pain. Beckwith, M., Cushman, D., Clark, T., et al.[2023]

Radiofrequency neurotomy of genicular nerves is an effective technique for reducing chronic knee pain, particularly after total knee replacement, as demonstrated in a case study of a patient with persistent pain.

The successful application of this technique in the patient's inferior right limb highlights its potential as a treatment option for managing post-surgical knee pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of post-total knee replacement gonalgy by radiofrequency ablation of the genicular nerves]. Sanfilippo, J., Fontaine, R., Brichant, JF.[2021]

In a study involving 54 patients with chronic knee pain due to osteoarthritis, genicular nerve radiofrequency ablation (cRFA) led to significant pain relief and improved physical function for up to six months, regardless of whether a prognostic nerve block was used beforehand.

The use of a genicular nerve block to predict the success of cRFA did not enhance treatment outcomes, as similar rates of pain relief were observed in both the block and no block groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Randomized Trial of Prognostic Genicular Nerve Blocks to Determine the Predictive Value for the Outcome of Cooled Radiofrequency Ablation for Chronic Knee Pain Due to Osteoarthritis. McCormick, ZL., Reddy, R., Korn, M., et al.[2022]

A novel protocol for genicular nerve radiofrequency ablation (RFA) targeting additional articular branches resulted in significant pain relief for 91% of patients at one month, with improvements sustained at six months.

The study involved 11 patients with chronic knee pain, and notably, there were no complications reported, indicating the safety of this new approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain Using a Three-Tined Electrode: A Technical Description and Case Series. Koshi, E., Cheney, CW., Sperry, BP., et al.[2021]

An updated protocol for cooled genicular nerve radiofrequency ablation (RFA) has been developed to improve the targeting of sensory nerves in the knee, based on recent cadaveric studies that identified additional sensory nerves and anatomical variations.

This new protocol aims to enhance sensory denervation and potentially improve clinical outcomes for patients with chronic knee pain due to osteoarthritis, although further prospective studies are needed to validate its effectiveness and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Technical Protocol for Improved Capture of the Genicular Nerves by Radiofrequency Ablation. Conger, A., Cushman, DM., Walker, K., et al.[2020]

Patients who underwent total knee arthroplasty (TKA) after genicular nerve radiofrequency ablation (GNRFA) had significantly lower odds of prolonged postoperative opioid use compared to those who had TKA alone, indicating a potential benefit in pain management.

The study found no significant differences in 2-year surgical outcomes or complication rates between the GNRFA-TKA group and the control group, suggesting that GNRFA does not increase the risk of complications when proceeding to TKA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total Knee Arthroplasty After Genicular Nerve Radiofrequency Ablation: Reduction in Prolonged Opioid Use Without Increased Postsurgical Complications. Stake, S., Agarwal, AR., Coombs, S., et al.[2022]

In a study of 32 patients with severe knee osteoarthritis, ultrasound-guided radiofrequency thermocoagulation of genicular nerves significantly reduced pain levels, with scores dropping from an average of 7.69 before treatment to 2.19 at three months post-treatment (P < 0.001).

The study found that the needle tip was effectively positioned in the anterior portion of the bone shaft in 71.9% of cases, suggesting that ultrasound guidance can achieve effective pain relief without needing to advance the needle further posteriorly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoroscopic Confirmation of Needle Location in Ultrasound-guided Genicular Nerve Radiofrequency Thermocoagulation. Polat, OE., Kokar, S.[2023]

In a study involving 9 patients with medial knee osteoarthritis, ultrasound-guided genicular nerve pulsed radiofrequency treatment significantly reduced pain levels, as measured by the visual analog scale (VAS), over a 3-month period.

The treatment also led to notable improvements in knee function, assessed using the WOMAC index, indicating that genicular nerve pulsed RF is a promising and safe option for managing osteoarthritis-related knee pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Genicular Nerve Pulsed Radiofrequency Treatment For Painful Knee Osteoarthritis: A Preliminary Report. Kesikburun, S., Yaşar, E., Uran, A., et al.[2022]

References

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

Genicular nerve radiofrequency ablation: An option for knee osteoarthritis pain. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Radiofrequency Ablation of the Infrapatellar Branch of the Saphenous Nerve for the Treatment of Chronic Anterior Inferomedial Knee Pain. [2023]

3. Belgium pubmed.ncbi.nlm.nih.gov

[Treatment of post-total knee replacement gonalgy by radiofrequency ablation of the genicular nerves]. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A Prospective Randomized Trial of Prognostic Genicular Nerve Blocks to Determine the Predictive Value for the Outcome of Cooled Radiofrequency Ablation for Chronic Knee Pain Due to Osteoarthritis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain Using a Three-Tined Electrode: A Technical Description and Case Series. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A Novel Technical Protocol for Improved Capture of the Genicular Nerves by Radiofrequency Ablation. [2020]

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

Total Knee Arthroplasty After Genicular Nerve Radiofrequency Ablation: Reduction in Prolonged Opioid Use Without Increased Postsurgical Complications. [2022]

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

Fluoroscopic Confirmation of Needle Location in Ultrasound-guided Genicular Nerve Radiofrequency Thermocoagulation. [2023]

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

Ultrasound-Guided Genicular Nerve Pulsed Radiofrequency Treatment For Painful Knee Osteoarthritis: A Preliminary Report. [2022]