Clinical trial NCT02947321: Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial
Official title: GREAT Knee Pain Reduction Trial, Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroplasty, Total
Osteoarthritis
Radiologic Tibiofemoral Osteoarthritis
Keywords: Radiofrequency ablation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2016-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Comparison of pain score at rest
timeFrame: 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.
measure: Comparison of pain score with ambulation
timeFrame: 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 outcomes:
measure: Comparison of PROMIS physical function score
timeFrame: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
measure: Comparison of PROMIS global health score
timeFrame: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
measure: Comparison of Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR)
timeFrame: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
measure: Comparison of 7-point Patient Global Impression of Change (PGIC)
timeFrame: Preoperatively on the day of surgery, and at week 2, 6, 24, and 52
measure: Comparison of Mobility using Timed Up and Go Test (TUG)
timeFrame: Day of genicular RFA or sham procedure, and postoperative day 1
measure: Comparison of Depression assessment using Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Day of genicular RFA or sham procedure and at 6 weeks postoperatively
measure: Comparison of Total opioid use in morphine equivalents
timeFrame: Day of genicular RFA or sham procedure, day of surgery, post op dy 1 and 2, and at weeks 2,6 postoperatively
measure: Assessment of pain location using Michigan Body Map
timeFrame: Day of genicular nerve RFA
measure: Assessment of pain catastrophizing using Catastrophizing General Chronic Pain (CAT) Scale
timeFrame: Day of genicular RFA or sham procedure
measure: Comparison of quadriceps strength
timeFrame: Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively
measure: Comparison Range of Motion - Knee
timeFrame: Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Puneet Mishra, MD
role: PRINCIPAL_INVESTIGATOR
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