Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial

Study Overview
=================
Brief Summary
-----------------
Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and functional status in non-surgical patients with knee osteoarthritis as well as the high prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA. Patients will be randomized to one of two study arms: RFA group (genicular nerve thermal RFA) or control group (RFA needles placed in proper location without effective neurotomy).

Detailed Description
-----------------
Total knee arthroplasty (TKA) is a common and effective treatment for severe knee osteoarthritis. As the average age of the population increases in developed countries, the number of TKAs performed is projected to increase to 3.48 million procedures per year by 2030, a 673% increase from 2005. Although TKA is widely accepted as an efficacious form of treatment for severe knee osteoarthritis, the incidence of patient dissatisfaction and postoperative pain cannot be ignored. Genicular nerve RFA has been performed in non-surgical patients with chronic knee osteoarthritis with significant post procedure improvement in pain and functional status. This study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA.

Official Title
-----------------
GREAT Knee Pain Reduction Trial, Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial

Conditions
-----------------
Knee Arthroplasty, Total, Osteoarthritis, Radiologic Tibiofemoral Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Genicular Nerve RFA
* Procedure: Sham Genicular Nerve RFA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgical candidate for total knee arthroplasty secondary to osteoarthritis Radiologic tibiofemoral osteoarthritis (Kellgren-Lawrence grade 2-4) Exclusion Criteria: Worst knee pain score on day of evaluation <4/10 Already taking opioids >100 mg/day of morphine equivalent dose Infectious etiology (over RFA insertion site or systemic) Workers compensation History of adverse reaction to local anesthetic or contrast History of intraarticular injection in the last 6 weeks with steroids or hyaluronic acids Prior total knee arthroplasty Prior open knee surgery or ligament reconstruction Prior RFA of knee joint Connective tissue diseases affecting the knee Sciatic pain Pacemaker Pregnancy Severe medical disease Serious neurological disorders Serious psychiatric disorders Suicidal or homicidal ideation BMI>50

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA Group<br>A genicular nerve RFA will be performed prior to planned total knee arthroplasty. | Procedure: Genicular Nerve RFA<br>* Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. RFA probes will be placed and connected to the RFA generator and the generator is activated. The RFA is performed.<br>|
| Sham Comparator: Control Group<br>A sham genicular nerve RFA will be performed prior to planned total knee arthroplasty. | Procedure: Sham Genicular Nerve RFA<br>* Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. The RFA probes for the control group will not be connected to the RFA generator (no neurotomy); however, the generator will still be activated to mimic the RFA group.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of pain score at rest | Pain score at rest using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) | On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52. | 
| Comparison of pain score with ambulation | Pain score with ambulation using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) | On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of PROMIS physical function score | Physical function assessment using the PROMIS physical function score | On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52 | 
| Comparison of PROMIS global health score | Global health assessment using the PROMIS global health score | On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52 | 
| Comparison of Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR) | Outcome assessment using the Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR) | On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52 | 
| Comparison of 7-point Patient Global Impression of Change (PGIC) | Assessment of the subject's belief about the efficacy of treatment using the PGIC. | Preoperatively on the day of surgery, and at week 2, 6, 24, and 52 | 
| Comparison of Mobility using Timed Up and Go Test (TUG) | Assessment of mobility using the TUG test | Day of genicular RFA or sham procedure, and postoperative day 1 | 
| Comparison of Depression assessment using Center for Epidemiologic Studies Depression Scale (CES-D) | Screening for depression using the CES-D | Day of genicular RFA or sham procedure and at 6 weeks postoperatively | 
| Comparison of Total opioid use in morphine equivalents |  | Day of genicular RFA or sham procedure, day of surgery, post op dy 1 and 2, and at weeks 2,6 postoperatively | 
| Assessment of pain location using Michigan Body Map |  | Day of genicular nerve RFA | 
| Assessment of pain catastrophizing using Catastrophizing General Chronic Pain (CAT) Scale |  | Day of genicular RFA or sham procedure | 
| Comparison of quadriceps strength |  | Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively | 
| Comparison Range of Motion - Knee |  | Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiofrequency ablation