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Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial

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ClinicalTrials.gov Identifier: NCT02947321
Recruitment Status : Completed
First Posted : October 27, 2016
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
Puneet Mishra, Vanderbilt University Medical Center

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Knee Arthroplasty, Total Osteoarthritis Radiologic Tibiofemoral Osteoarthritis Procedure: Genicular Nerve RFA Procedure: Sham Genicular Nerve RFA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GREAT Knee Pain Reduction Trial, Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial
Actual Study Start Date : January 26, 2018
Actual Primary Completion Date : September 9, 2020
Actual Study Completion Date : September 9, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947321


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Abbott Medical Devices
Investigators
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Principal Investigator: Puneet Mishra, MD Vanderbilt University Medical Center
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Puneet Mishra, Assistant Professor of Anesthesiology and Pain Medicine, BH Robbins Scholar, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02947321    
Other Study ID Numbers: 160663
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Puneet Mishra, Vanderbilt University Medical Center:
Radiofrequency ablation
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases