Radiofrequency Ablation for Osteoarthritis Post-Knee Replacement (GRATKA Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Calgary
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
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.
Is Genicular Radiofrequency Ablation a promising treatment for knee pain after knee replacement?Yes, Genicular Radiofrequency Ablation is a promising treatment for knee pain after knee replacement. It is effective for managing chronic knee pain related to osteoarthritis, especially when other treatments have not worked. It can help people who want to avoid more surgery or who still have pain after knee replacement surgery.13689
What data supports the idea that Radiofrequency Ablation for Osteoarthritis Post-Knee Replacement is an effective treatment?The available research shows that Radiofrequency Ablation (RFA) is effective for reducing chronic knee pain related to osteoarthritis, especially when other treatments have not worked. One study highlights that RFA is beneficial for patients who have persistent pain after knee replacement surgery. Another study confirms that RFA can help those who are not suitable for surgery or want to avoid it. Overall, these studies suggest that RFA can significantly reduce knee pain and improve the quality of life for patients with osteoarthritis.24568
What safety data exists for genicular nerve radiofrequency ablation in treating knee osteoarthritis?Genicular nerve radiofrequency ablation (GNRFA) is considered a safe and effective treatment for chronic knee pain due to osteoarthritis, especially when conservative treatments have failed. Studies indicate that GNRFA can reduce pain and improve functionality without increasing postsurgical complications, even in patients undergoing total knee arthroplasty after the procedure. However, there is anatomical variation in nerve locations, which can impact the procedure's success and safety.23678
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, since the trial is for patients whose pain is refractory to conventional treatment, it might be assumed that you can continue your current medications unless otherwise directed by the trial coordinators.
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.
I have had knee pain above 4 out of 10 in one of my knees after knee replacement surgery.
Exclusion Criteria
I have leg pain from poor blood flow when I walk.
I do not have a condition that causes uncontrolled bleeding.
I do not have any infections, including skin or joint infections near my knee.
I have a condition affecting my joints or causing widespread pain.
I am allergic to local anesthetics.
My leg pain comes from my spine or joints, not my knee.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 (GRFA)Experimental Treatment1 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 Control1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Vivo Cura HealthCalgary, Canada
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Who is running the clinical trial?
University of CalgaryLead Sponsor
References
Ultrasound-Guided Genicular Nerve Pulsed Radiofrequency Treatment For Painful Knee Osteoarthritis: A Preliminary Report. [2022]Genicular nerve ablation with radiofrequency (RF) has recently emerged as a promising treatment in the management of osteoarthritis related knee pain. To date, genicular nerve injections have been performed under fluoroscopic guidance.
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]Genicular nerve radiofrequency ablation is an effective treatment for patients with chronic pain due to knee osteoarthritis; however, little is known about factors that predict procedure success. The current study evaluated the utility of genicular nerve blocks to predict the outcome of genicular nerve cooled radiofrequency ablation (cRFA) in patients with osteoarthritis.
A Novel Technical Protocol for Improved Capture of the Genicular Nerves by Radiofrequency Ablation. [2020]Fluoroscopically guided cooled genicular nerve radiofrequency ablation (RFA) is an increasingly performed procedure for chronic, refractory knee pain due to osteoarthritis. Traditionally, partial sensory denervation has been accomplished through ablation of the superomedial, superolateral, and inferomedial genicular nerves. However, recent cadaveric studies have demonstrated additional sensory nerves and significant anatomic variation that impact current protocols.
Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain Using a Three-Tined Electrode: A Technical Description and Case Series. [2021]Genicular nerve radiofrequency ablation (RFA) for the treatment of chronic knee pain has traditionally targeted the superomedial, superolateral, and inferomedial genicular nerves. However, recent cadaveric studies of knee neuroanatomy demonstrate varied locations of these specific nerves as well as additional articular nerves. This work suggests that traditional genicular nerve RFA lesion locations may be inadequate.
[Treatment of post-total knee replacement gonalgy by radiofrequency ablation of the genicular nerves]. [2021]Neurotomy of genicular nerves by radiofrequency is a technique efficient to reduce mecanic knee pain and pain after total knee replacement. In this article, we describe the case of a patient that has suffered from chronic knee pain after total knee replacement. The patient has successfully benefited of a neurotomy of genicular nerves by radiofrequency in the inferior right limb.
Radiofrequency Ablation of the Infrapatellar Branch of the Saphenous Nerve for the Treatment of Chronic Anterior Inferomedial Knee Pain. [2023]Genicular nerve radiofrequency ablation (GNRFA) is an effective treatment for chronic knee pain related to osteoarthritis. It is often utilized when conservative management has failed and patients wish to avoid arthroplasty, are poor surgical candidates due to comorbid medical conditions, or in those suffering from persistent pain after arthroplasty. The classic targets for GNRFA include the superior lateral genicular nerve, superior medial genicular nerve, and inferior medial genicular nerve but multiple anatomic studies have demonstrated additional sensory innervation to the knee.
Total Knee Arthroplasty After Genicular Nerve Radiofrequency Ablation: Reduction in Prolonged Opioid Use Without Increased Postsurgical Complications. [2022]Genicular nerve radiofrequency ablation (GNRFA) is an increasingly used nonsurgical treatment modality for patients with advanced knee osteoarthritis. Previous studies have demonstrated this to be an effective and safe method to decrease pain and increase functionality in this patient population. The purpose of this study was to compare 2-year postoperative complication rates and rates of prolonged postoperative opioid usage between patients undergoing total knee arthroplasty (TKA) after previous GNRFA and those undergoing TKA alone.
Genicular nerve radiofrequency ablation: An option for knee osteoarthritis pain. [2023]Genicular nerve radiofrequency ablation is an option to treat osteoarthritic knee pain unresponsive to conservative and minimally invasive measures. This article reviews genicular nerve radiofrequency ablation, neuroanatomy of the knee, patient selection, results, and risks and complications of the procedure.
Fluoroscopic Confirmation of Needle Location in Ultrasound-guided Genicular Nerve Radiofrequency Thermocoagulation. [2023]Radiofrequency thermocoagulation of genicular nerves is an effective treatment for chronic pain due to knee osteoarthritis. The procedure can be performed under fluoroscopic or ultrasonographic guidance.