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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02947321
Other study ID # 160663
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 26, 2018
Est. completion date September 9, 2020

Study information

Verified date September 2020
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 Design


Related Conditions & MeSH terms


Intervention

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 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.

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Medical Center Abbott Medical Devices

Country where clinical trial is conducted

United States, 

References & Publications (16)

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Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of pain score at rest 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.
Primary Comparison of pain score with ambulation 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 Comparison of PROMIS physical function score 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
Secondary Comparison of PROMIS global health score 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
Secondary Comparison of Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR) 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
Secondary Comparison of 7-point Patient Global Impression of Change (PGIC) 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
Secondary Comparison of Mobility using Timed Up and Go Test (TUG) Assessment of mobility using the TUG test Day of genicular RFA or sham procedure, and postoperative day 1
Secondary Comparison of Depression assessment using Center for Epidemiologic Studies Depression Scale (CES-D) Screening for depression using the CES-D Day of genicular RFA or sham procedure and at 6 weeks postoperatively
Secondary Comparison of Total opioid use in morphine equivalents Day of genicular RFA or sham procedure, day of surgery, post op dy 1 and 2, and at weeks 2,6 postoperatively
Secondary Assessment of pain location using Michigan Body Map Day of genicular nerve RFA
Secondary Assessment of pain catastrophizing using Catastrophizing General Chronic Pain (CAT) Scale Day of genicular RFA or sham procedure
Secondary Comparison of quadriceps strength Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively
Secondary Comparison Range of Motion - Knee Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively
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