Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial

October 1, 2020 updated by: Puneet Mishra, Vanderbilt University Medical Center

GREAT Knee Pain Reduction Trial, Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial

Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and functional status in non-surgical patients with knee osteoarthritis as well as the high prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA. Patients will be randomized to one of two study arms: RFA group (genicular nerve thermal RFA) or control group (RFA needles placed in proper location without effective neurotomy).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Total knee arthroplasty (TKA) is a common and effective treatment for severe knee osteoarthritis. As the average age of the population increases in developed countries, the number of TKAs performed is projected to increase to 3.48 million procedures per year by 2030, a 673% increase from 2005. Although TKA is widely accepted as an efficacious form of treatment for severe knee osteoarthritis, the incidence of patient dissatisfaction and postoperative pain cannot be ignored. Genicular nerve RFA has been performed in non-surgical patients with chronic knee osteoarthritis with significant post procedure improvement in pain and functional status. This study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Surgical candidate for total knee arthroplasty secondary to osteoarthritis
  • Radiologic tibiofemoral osteoarthritis (Kellgren-Lawrence grade 2-4)

Exclusion Criteria:

  • Worst knee pain score on day of evaluation <4/10
  • Already taking opioids >100 mg/day of morphine equivalent dose
  • Infectious etiology (over RFA insertion site or systemic)
  • Workers compensation
  • History of adverse reaction to local anesthetic or contrast
  • History of intraarticular injection in the last 6 weeks with steroids or hyaluronic acids
  • Prior total knee arthroplasty
  • Prior open knee surgery or ligament reconstruction
  • Prior RFA of knee joint
  • Connective tissue diseases affecting the knee
  • Sciatic pain
  • Pacemaker
  • Pregnancy
  • Severe medical disease
  • Serious neurological disorders
  • Serious psychiatric disorders
  • Suicidal or homicidal ideation
  • BMI>50

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RFA Group
A genicular nerve RFA will be performed prior to planned total knee arthroplasty.
Procedure: Genicular Nerve RFA
Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. RFA probes will be placed and connected to the RFA generator and the generator is activated. The RFA is performed.
SHAM_COMPARATOR: Control Group
A sham genicular nerve RFA will be performed prior to planned total knee arthroplasty.
Procedure: Sham Genicular Nerve RFA
Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. The RFA probes for the control group will not be connected to the RFA generator (no neurotomy); however, the generator will still be activated to mimic the RFA group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of pain score at rest
Time Frame: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.
Pain score at rest using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)
On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.
Comparison of pain score with ambulation
Time Frame: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.
Pain score with ambulation using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)
On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of PROMIS physical function score
Time Frame: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Physical function assessment using the PROMIS physical function score
On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Comparison of PROMIS global health score
Time Frame: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Global health assessment using the PROMIS global health score
On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Comparison of Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR)
Time Frame: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Outcome assessment using the Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR)
On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Comparison of 7-point Patient Global Impression of Change (PGIC)
Time Frame: Preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Assessment of the subject's belief about the efficacy of treatment using the PGIC.
Preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Comparison of Mobility using Timed Up and Go Test (TUG)
Time Frame: Day of genicular RFA or sham procedure, and postoperative day 1
Assessment of mobility using the TUG test
Day of genicular RFA or sham procedure, and postoperative day 1
Comparison of Depression assessment using Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Day of genicular RFA or sham procedure and at 6 weeks postoperatively
Screening for depression using the CES-D
Day of genicular RFA or sham procedure and at 6 weeks postoperatively
Comparison of Total opioid use in morphine equivalents
Time Frame: Day of genicular RFA or sham procedure, day of surgery, post op dy 1 and 2, and at weeks 2,6 postoperatively
Day of genicular RFA or sham procedure, day of surgery, post op dy 1 and 2, and at weeks 2,6 postoperatively
Assessment of pain location using Michigan Body Map
Time Frame: Day of genicular nerve RFA
Day of genicular nerve RFA
Assessment of pain catastrophizing using Catastrophizing General Chronic Pain (CAT) Scale
Time Frame: Day of genicular RFA or sham procedure
Day of genicular RFA or sham procedure
Comparison of quadriceps strength
Time Frame: Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively
Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively
Comparison Range of Motion - Knee
Time Frame: Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively
Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

Abbott Medical Devices

Investigators

  • Principal Investigator: Puneet Mishra, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 26, 2018

Primary Completion (ACTUAL)

September 9, 2020

Study Completion (ACTUAL)

September 9, 2020

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (ESTIMATE)

October 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160663

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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