Radiofrequency Ablation After Total Knee Arthroplasty

Our a priori decision rule for acceptability of RFA will be that 50% of the actively treated participants respond affirmatively at the 3-month visit: "Would you recommend the treatment used in this study to someone in a similar situation with knee pain after a knee replacement?"

<2 serious adverse events among 20 actively treated participants. After enrollment, participants will complete training regarding the daily notification for daily adverse event monitoring. During the study, participants will be automatically prompted daily to report adverse events on their mobile device or home computer. If a participant does not complete adverse event monitoring daily, a member of the study team will contact them to troubleshoot.

Additionally, a more thorough examination of patient safety will be conducted during the clinical exam in the 1-, 3-, and 6-month follow-up visits. Prosthesis safety will be assessed with skyline, lateral, and anteroposterior radiographs (e.g. aseptic loosening, osteolysis) at baseline and 6 months69. Serious adverse events will be consistent with our institution's IRB definitions and with a definition of serious adverse drug experience in FDA 21 CFR 312.32(a).

<5 number needed to treat to achieve a patient-acceptable symptom state. Patient acceptable symptom state will be defined with the following question: "Think about all consequences of your arthroplasty in the last week. If you were to remain for the rest of your life as you were last week, would the current state be acceptable or unacceptable for you?"61 Primary efficacy measure will be whether a participant considers themselves in an acceptable symptom state at the 3-month visit after the intervention. A <5 number is needed to treat to achieve a patient-acceptable symptom state.

Change from baseline in daily pain number rating scale (NRS) scores via text or online platform until study completion. Min= 0, Max=10. Larger change in scores mean a better outcome.

Change from baseline in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living subscales at 1-, 3-, and 6-month visits. Questions measured from 0-4. Min = 0 (none), Max= 4 (extreme). Larger change in scores mean a better outcome.

Change from baseline in the Physical Activity Scale for the Elderly (PASE) at 1-, 3-, and 6-month visits. Measured based on frequency 0 (never)- 3 (often). Larger change in score means better outcome.

Change from baseline in the KOOS Quality of Life subscale at 1-, 3-, and 6-month visits. not at all- extreme. Larger change in score means better outcome.

Change from baseline in the PROMIS Global 10 at 1-, 3-, and 6-month visits.

Change from baseline in 20-meter walk test time at 1-, 3-, and 6 month visits

Change from baseline in chair stand speed at 1-, 3-, and 6- month visits

Change from baseline in daily step count via Wearable Activity Monitor (i.e. Fitbit) averaged over the one week following 1-, 3-, and 6- month visits

Change from baseline in usage of pain medication for target knee pain at 1-, 3-, and 6- month visits. Measured using questionnaire.

An optional sub-study will assess change from baseline in spatiotemporal metrics of gait at the 3 month visit. . Data collected will include knee kinematics and kinetics using optical motion capture and spatiotemporal gait parameters using wearable inertial sensors. Larger change from baseline means better outcome.