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Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain

NCT04145011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2023-08-08

No results posted yet for this study

Summary

This study is being performed to assess the relative effectiveness of genicular nerve ablation with the COOLIEF\* Cooled Radiofrequency probe to manage moderate to severe knee pain in patients with osteoarthritis (OA) of the knee when compared to radiofrequency ablation using a Standard Radiofrequency probe.

Conditions

  • Osteoarthritis of the Knee

Interventions

DEVICE

Cooled Radiofrequency

Delivery of energy to ablate sensory nerves via cooled radiofrequency probe (18g, 4mm active tip)

DEVICE

Standard Radiofrequency

Delivery of energy to ablate sensory nerves via non-cooled standard radiofrequency probe (22g, curved 10mm active tip)

Sponsors & Collaborators

  • Avanos Medical

    lead OTHER

Principal Investigators

  • David Kennedy, MD · Vanderbilt Stallworth Rehabilitation Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-04
Primary Completion
2021-10-29
Completion
2022-10-10
FDA Device
Yes

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 NCT04145011 on ClinicalTrials.gov