CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Genicular Nerve RFA +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02947321
NCT02947321N/ACompleted
CompareCT.gov

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

Vanderbilt University Medical Center·interventional·Posted Oct 27, 2016·Updated Oct 5, 2020

In Brief

A clinical study evaluating Genicular Nerve RFA and Sham Genicular Nerve RFA for Knee Arthroplasty, Total and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Arthroplasty, Total, Osteoarthritis, Radiologic Tibiofemoral Osteoarthritis
CountriesUnited States
CollaboratorsAbbott Medical Devices

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 27, 2016
Enrollment StartJan 26, 2018
Primary CompletionSep 9, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.7 years ago

Interventions

Genicular Nerve RFAprocedure

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 RFAprocedure

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.