Radiofrequency For Chronic Knee Pain Post-Arthroplasty (DEFIANT)

December 11, 2018 updated by: Randall Brewer, MD, CPI

Radiofrequency For The Treatment Of Chronic Knee Pain Following Total Knee Arthroplasty: A Double-Blind Randomized Controlled Pilot Study

Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.

The purpose of this study is to evaluate whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.

As the prevalence of knee arthroplasty increases, so does the frequency of revisions. It has been found that 20% of patients reporting painful knee arthroplasties were not able to be diagnosed with a specific cause and were therefore referred to a pain specialist. Pharmacologic therapy and non-surgical interventions are often employed with minimal benefit to the patient's level of disability as indicated by clinical evidence.

Genicular radiofrequency ablation seems to be a safe, effective and minimally invasive therapy for chronic knee OA patients who have had a positive diagnostic block. No study has determined whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain. The investigators propose to examine the effect of genicular radiofrequency ablation in chronic post-arthroplasty knee pain in patients who respond positively to diagnostic nerve blocks.

Study Type

Interventional

Enrollment (Actual)

9

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
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • WK River Cities Clinical Research 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

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Study candidate must provide written informed consent.
  • Must be ≥ 50 years of age at the time of consent
  • Chronic knee pain despite total knee arthroplasty at least 6 months prior to consent
  • Orthopedic evaluation indicating no further surgery is warranted
  • Stable pain medication regimen for 30 days prior to baseline visit
  • Knee pain is primary pain complaint

Exclusion Criteria:

  • Acute knee pain
  • Connective tissue disorders affecting the knee
  • Serious neurologic or psychiatric disorders that would affect the outcome of the study as determined by the Principal Investigator
  • Steroid or hyaluronic acid injections into the affected knee in the past 3 months
  • Confounding pain conditions of the index leg that may affect medication requirements or study outcomes

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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Nerve Block with Radiofrequency Ablation
A 10 cm 18-gauge RF cannula with a 10 mm active tip will be placed at the superior lateral, superior medial, and inferior medial nerve positions under fluoroscopic guidance. Sensory stimulation at 50 Hz will be performed to identify nerve position and to assure no motor nerves will be ablated. Lidocaine (2 ml of 2%) will be administered in each location prior to RF generator activation.
Procedure: Nerve Block with Radiofrequency Ablation
Ablation of the genicular nerves of the knee by radiofrequency
SHAM_COMPARATOR: Nerve Block with Sham Radiofrequency Ablation
A 10 cm 18-gauge RF cannula with a 10 mm active tip will be placed at the superior lateral, superior medial, and inferior medial nerve positions under fluoroscopic guidance.Control patients will undergo the same procedure without RF generator activation. Sensory stimulation at 50 Hz will be performed to identify nerve position and to assure no motor nerves will be ablated. Lidocaine (2 ml of 2%) will be administered in each location prior to RF generator sham activation.
Procedure: Nerve Block with Sham Radiofrequency Ablation
Genicular radiofrequency of the knee without neurotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean difference in knee pain intensities as indicated on the Visual Analog Scale
Time Frame: Baseline and 6 weeks post-radiofrequency ablation
Baseline and 6 weeks post-radiofrequency ablation

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Visual Analog Score of average knee pain
Time Frame: Baseline to 1 week, 6 weeks, and 12 weeks
Baseline to 1 week, 6 weeks, and 12 weeks
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: Baseline to 1 week, 6 weeks, and 12 weeks
Baseline to 1 week, 6 weeks, and 12 weeks
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline to 1 week, 6 weeks, and 12 weeks
Baseline to 1 week, 6 weeks, and 12 weeks
Change of Patient Global Assessment
Time Frame: Baseline to 1 week, 6 weeks, and 12 weeks
Baseline to 1 week, 6 weeks, and 12 weeks
Satisfaction with Radiofrequency Procedure
Time Frame: Baseline to 1 week, 6 weeks, and 12 weeks
Baseline to 1 week, 6 weeks, and 12 weeks
Rate of procedure-related Adverse Events
Time Frame: From informed consent through study completion, up to 20 weeks
From informed consent through study completion, up to 20 weeks
Rate of Serious Adverse Events
Time Frame: From informed consent through study completion, up to 20 weeks
From informed consent through study completion, up to 20 weeks

Collaborators and Investigators

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

Sponsor

Randall Brewer, MD, CPI

Collaborators

Abbott Medical Devices
Abbott

Investigators

  • Principal Investigator: Randall Brewer, MD, WK River Cities Clinical Research 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

December 1, 2016

Primary Completion (ACTUAL)

November 20, 2018

Study Completion (ACTUAL)

November 30, 2018

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (ESTIMATE)

October 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2018

Last Update Submitted That Met QC Criteria

December 11, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GENRF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Osteoarthritis, Knee

Clinical Trials on Nerve Block with Radiofrequency Ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe