Radiofrequency Ablation After Total Knee Arthroplasty

NCT ID: NCT05473663

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Radiofrequency Ablation

Patient undergoing genicular nerve radiofrequency ablation.

Group Type: ACTIVE_COMPARATOR

Radiofrequency Ablation

Intervention Type: 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.

Sham

Patient undergoing sham.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

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

Interventions

Radiofrequency Ablation

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.

Intervention Type: DEVICE

Sham

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: collaborator

Tufts Medical Center

OTHER

Sponsor Role: collaborator

Rheumatology Research Foundation

OTHER

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Timothy McAlindon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy E McAlindon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UMass Worcester (UMass Chan Medical School)

Locations

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

STUDY00001815

Identifier Type: -

Identifier Source: org_study_id