Radiofrequency Ablation After Total Knee Arthroplasty

NCT05473663 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-01-07

No results posted yet for this study

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

Interventions

DEVICE

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.

DEVICE

Sham

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

Sponsors & Collaborators

  • Boston University

    collaborator OTHER
  • Tufts Medical Center

    collaborator OTHER
  • Rheumatology Research Foundation

    collaborator OTHER
  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Timothy E McAlindon, MD, MPH · UMass Worcester (UMass Chan Medical School)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-07-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05473663 on ClinicalTrials.gov