Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial
Completed · Not applicable · Has a placebo group
Conditions studied: Knee Arthroplasty, Total, Osteoarthritis, Radiologic Tibiofemoral Osteoarthritis
In brief
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).
Key facts
- Study ID
- NCT02947321
- Run by
- Vanderbilt University Medical Center
- People needed
- 60
- Starts
- 2018-01-26
- Expected to finish
- 2020-09-09
- Last updated by the study team
- 2020-10-05
Who can join
Age: 45 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Surgical candidate for total knee arthroplasty secondary to osteoarthritis
- Radiologic tibiofemoral osteoarthritis (Kellgren-Lawrence grade 2-4)
You may not qualify if…
- 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
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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