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NCT Number: NCT02947321

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).

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Key information

Conditions

Knee Arthroplasty, Total Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Radiologic Tibiofemoral Osteoarthritis Rheumatic Diseases

Age range

45 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Genicular Nerve RFA

Procedure

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 Genicular Nerve RFA

Procedure

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.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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.

  5. 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

  6. 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

  7. 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

  8. Assessment of pain location using Michigan Body Map

    Time frame: Day of genicular nerve RFA

  9. Assessment of pain catastrophizing using Catastrophizing General Chronic Pain (CAT) Scale

    Time frame: Day of genicular RFA or sham procedure

  10. Comparison of quadriceps strength

    Time frame: Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively

  11. Comparison Range of Motion - Knee

    Time frame: Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Abbott Medical Devices

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 27, 2016
Registry last updated
Oct 5, 2020

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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