Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:45 - 79
Updated:3/7/2019
Start Date:January 26, 2018
End Date:July 2020
Contact:Puneet Mishra, MD
Email:puneet.mishra@vumc.org
Phone:615-305-0657

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

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).

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.

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
We found this trial at
1
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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