Radiofrequency Ablation After Total Knee Arthroplasty

Not Applicable

Active, not recruiting

• Conditions: Chronic Knee Pain
• Interventions: Device: Sham; Device: Radiofrequency Ablation

• Registration Number: NCT05473663
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

The purpose of this study is to assess how clinically useful and safe genicular nerve radiofrequency ablation is in people with chronic pain after total knee arthroplasty performed for osteoarthritis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-26
• Study Start: 2022-09-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-07-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Eligible individuals over 18 years of age in general good health apart from their chronic knee pain
2. At least one year post-TKA
3. Report of chronic knee pain classified using a standard question about the presence of "pain, aching, or stiffness in the knee on most days for at least one month during the prior 6 months"
4. In an unacceptable symptom state classified using a validated 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 during the last week, would the current state be acceptable or unacceptable for you?"
5. Willingness to complete all the study procedures, including a daily pain NRS, AE, and medication usage questions via daily notification
6. Subjects must have read and understood the informed consent form (ICF), and must have signed and dated it prior to any study-related procedure being performed

Exclusion Criteria

1. Pregnant women, breastfeeding women, and women who are not post-menopausal (defined at 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
2. Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control as outlined in Section 5.3.1 during the study period
3. Significant evidence of infection within the knee or radiographic evidence of prosthesis loosening as defined by the orthopedic surgeon
4. Individuals with pain exclusively located in the posterior knee, evaluated systematically using a validated Knee Pain Map
5. Individuals who do not achieve a 70% pain reduction following the initial prognostic block, consistent with clinical practice
6. Participation in a clinical research trial that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 30 days prior to the Screening Visit, or planned participation in any such trial
7. Use of anticoagulants and inability to withhold for three days prior to the study RFA procedure with clearance by the prescribing physician
8. Other conditions that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Sham	Patient undergoing sham.
Radiofrequency Ablation	Radiofrequency Ablation	Patient undergoing genicular nerve radiofrequency ablation.

Primary Outcome Measures

Name	Time	Method
Efficacy Outcome	3 months	\<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.
Acceptability by actively treated participants Outcome	3 months	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?"
Safety Outcome	6 months	\<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).

Secondary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS)	1-, 3-, and 6-month visits	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.
Physical Activity Scale for the Elderly (PASE)	1-, 3-, and 6-month visits	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.
Walk Test	1-, 3-, and 6-month visits	Change from baseline in 20-meter walk test time at 1-, 3-, and 6 month visits
Incidence of Pain Medication use	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.
Pain Number Rating Score (NRS)	6 months	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.
Quality of Life Measured using Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS QOL)	1-, 3-, and 6-month visits	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.
Daily Step Count	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
Quality of Life Measured using Patient Reported Outcome Measurement Information System (PROMIS) Global 10	1-, 3-, and 6-month visits	Change from baseline in the PROMIS Global 10 at 1-, 3-, and 6-month visits.
Chair Stand Test	1-, 3-, and 6-month visits	Change from baseline in chair stand speed at 1-, 3-, and 6- month visits
Gait Analysis	3 months	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.

Trial Locations

Locations (1)

University of Massachusetts Chan Medical School; 🇺🇸 Worcester, Massachusetts, United States