CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 151 enrolled
Drug / intervention
Corticosteroid injection +1 moredrug
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/NCT02343003
NCT02343003N/ACompleted
CompareCT.gov

A Prospective, Multi-Center, RCT Evaluating the Safety and Effectiveness of Coolief™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing Corticosteroid Injection in the Management of Knee Pain

Halyard Health·interventional·Posted Jan 21, 2015·Updated May 13, 2019

In Brief

A clinical study evaluating Cooled Radiofrequency and Corticosteroid injection for Osteoarthritis of the Knee. Completed, enrolled 151 participants across 11 sites.

Detailed Summary

This study is designed to: * Determine the effectiveness (primarily measured by pain relief) of Coolief when used to create radiofrequency lesions of the genicular nerves compared to pain relief following corticosteroid injection; and * Confirm the safety of Coolief when used to perform radiofrequency lesions of the genicular nerves in subjects to manage knee pain compared to safety of corticosteroid injection

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis of the Knee
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 21, 2015
Enrollment StartJan 1, 2015
Primary CompletionAug 1, 2016
Study CompletionMar 16, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.4 years ago

Interventions

Cooled Radiofrequencydevice

Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

Corticosteroid injectiondrug

Delivery of corticosteroid into knee by injection with needle to reduce knee pain