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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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.
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.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Comparison of pain score at rest
Pain score at rest using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)
Time frame: 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)
Time frame: 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 PROMIS physical function score
Physical function assessment using the PROMIS physical function score
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Day of genicular RFA or sham procedure and at 6 weeks postoperatively
Comparison of Total opioid use in morphine equivalents
Time frame: 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
Time frame: Day of genicular nerve RFA
Assessment of pain catastrophizing using Catastrophizing General Chronic Pain (CAT) Scale
Time frame: Day of genicular RFA or sham procedure
Comparison of quadriceps strength
Time frame: Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively
Comparison Range of Motion - Knee
Time frame: Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively
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