Radiofrequency Ablation After Total Knee Arthroplasty

NCT05473663 | Active Not Recruiting DMC FDA Device

• 1 other identifier: STUDY00001815
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Knee Pain

Outcome Measures

Primary Outcomes (3)

• Acceptability by actively treated participants Outcome

  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?"

  3 months

• Safety Outcome

  \<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).

  6 months

• Efficacy Outcome

  \<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.

  3 months

Secondary Outcomes (10)

• Pain Number Rating Score (NRS)

  6 months

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  1-, 3-, and 6-month visits

• Physical Activity Scale for the Elderly (PASE)

  1-, 3-, and 6-month visits

• Quality of Life Measured using Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS QOL)

  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

Study Arms (2)

Radiofrequency Ablation

ACTIVE COMPARATOR

Patient undergoing genicular nerve radiofrequency ablation.

Device: Radiofrequency Ablation

Sham

SHAM COMPARATOR

Patient undergoing sham.

Device: Sham

Interventions

Radiofrequency Ablation DEVICE

Genicular nerve RFA is a standard outpatient procedure using fluoroscopic guidance to ensure accurate placement of the radiofrequency cannula. After placement of the radiofrequency cannula, nerve stimulation is performed to confirm proper position and ensure that the cannula is not too close to motor fibers. One mL of 2% lidocaine is placed at each of the cannulas. The RFA treatment is then proceeded by rhizotomizing each genicular nerve at 80°C for 90 seconds with a 15-second ramp-up.

Radiofrequency Ablation

Sham DEVICE

Is performed identically to the active treatment but without the application of the RFA current

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible individuals over 18 years of age in general good health apart from their chronic knee pain
• At least one year post-TKA
• 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"
• 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?"
• Willingness to complete all the study procedures, including a daily pain NRS, AE, and medication usage questions via daily notification
• 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

You may not qualify if:

• 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)
• 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
• Significant evidence of infection within the knee or radiographic evidence of prosthesis loosening as defined by the orthopedic surgeon
• Individuals with pain exclusively located in the posterior knee, evaluated systematically using a validated Knee Pain Map
• Individuals who do not achieve a 70% pain reduction following the initial prognostic block, consistent with clinical practice
• 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
• Use of anticoagulants and inability to withhold for three days prior to the study RFA procedure with clearance by the prescribing physician
• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Boston University: collaborator
• Tufts Medical Center: collaborator
• Rheumatology Research Foundation: collaborator

Study Sites (1)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Timothy E McAlindon, MD, MPH

  UMass Worcester (UMass Chan Medical School)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 26, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)