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Nerve Ablation by Cooled Radiofrequency Compared to Corticosteroid Injection for Management of Knee Pain

NCT02343003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2019-05-13

Study results available
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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

Conditions

  • Osteoarthritis of the Knee

Interventions

DEVICE

Cooled Radiofrequency

Delivery of energy to ablate sensory nerves via cooled radiofrequency probe

DRUG

Corticosteroid injection

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

Sponsors & Collaborators

  • Halyard Health

    lead INDUSTRY

Principal Investigators

  • David T Curd, MS · Halyard Health, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-08-31
Completion
2017-03-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02343003 on ClinicalTrials.gov