Knee Arthroplasty, Total, Osteoarthritis, Radiologic Tibiofemoral Osteoarthritis
Conditions
Keywords
Radiofrequency ablation
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.
Interventions
PROCEDUREGenicular Nerve RFA
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.
PROCEDURESham Genicular Nerve RFA
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.
Sponsors
Abbott Medical Devices
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 79 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of pain score at rest | 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. | Pain score at rest using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) |
| Comparison of pain score with ambulation | 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. | Pain score with ambulation using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of PROMIS physical function score | On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52 | Physical function assessment using the PROMIS physical function score |
| Comparison of PROMIS global health score | On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52 | Global health assessment using the PROMIS global health score |
| Comparison of Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR) | On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52 | Outcome assessment using the Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR) |
| Comparison of 7-point Patient Global Impression of Change (PGIC) | Preoperatively on the day of surgery, and at week 2, 6, 24, and 52 | Assessment of the subject's belief about the efficacy of treatment using the PGIC. |
| Comparison of Mobility using Timed Up and Go Test (TUG) | Day of genicular RFA or sham procedure, and postoperative day 1 | Assessment of mobility using the TUG test |
| Comparison of Depression assessment using Center for Epidemiologic Studies Depression Scale (CES-D) | Day of genicular RFA or sham procedure and at 6 weeks postoperatively | Screening for depression using the CES-D |
| Comparison of Total opioid use in morphine equivalents | 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 | Day of genicular nerve RFA | — |
| Assessment of pain catastrophizing using Catastrophizing General Chronic Pain (CAT) Scale | Day of genicular RFA or sham procedure | — |
| Comparison of quadriceps strength | Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively | — |
| Comparison Range of Motion - Knee | Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively | — |
Countries
United States
Outcome results
None listed