Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial
Purpose
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).
Conditions
- Knee Arthroplasty, Total
- Osteoarthritis
- Radiologic Tibiofemoral Osteoarthritis
Eligibility
- Eligible Ages
- Between 45 Years and 79 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental RFA Group |
A genicular nerve RFA will be performed prior to planned total knee arthroplasty. |
|
|
Sham Comparator Control Group |
A sham genicular nerve RFA will be performed prior to planned total knee arthroplasty. |
|
More Details
- Status
- Completed
- Sponsor
- Vanderbilt University Medical Center
Study Contact
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.