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Completed

NCT Number: NCT02931435

Radiofrequency For Chronic Knee Pain Post-Arthroplasty

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WK River Cities Clinical Research Center

Shreveport, Louisiana, 71105, United States

About this 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nerve Block with Radiofrequency Ablation

Procedure

Ablation of the genicular nerves of the knee by radiofrequency

Nerve Block with Sham Radiofrequency Ablation

Procedure

Genicular radiofrequency of the knee without neurotomy

Primary outcomes

  1. Mean difference in knee pain intensities as indicated on the Visual Analog Scale

    Time frame: Baseline and 6 weeks post-radiofrequency ablation

Secondary outcomes

  1. Change in Visual Analog Score of average knee pain

    Time frame: Baseline to 1 week, 6 weeks, and 12 weeks

  2. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Baseline to 1 week, 6 weeks, and 12 weeks

  3. Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Baseline to 1 week, 6 weeks, and 12 weeks

  4. Change of Patient Global Assessment

    Time frame: Baseline to 1 week, 6 weeks, and 12 weeks

  5. Satisfaction with Radiofrequency Procedure

    Time frame: Baseline to 1 week, 6 weeks, and 12 weeks

  6. Rate of procedure-related Adverse Events

    Time frame: From informed consent through study completion, up to 20 weeks

  7. Rate of Serious Adverse Events

    Time frame: From informed consent through study completion, up to 20 weeks

Sponsors and collaborators

Lead sponsor

Randall Brewer, MD, CPI

Other

Collaborators

  • Abbott
  • Abbott Medical Devices

Registry information

Official study title

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

Acronym: DEFIANT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 13, 2016
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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