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Genicular Radiofrequency Ablation for Unilateral Knee Arthroplasty Pain Management

NCT02925442 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-05-24

No results posted yet for this study

Summary

Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Standard genicular radiofrequency ablation (t-RFA) has been effective pain management for non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency ablation (C-RFA), is now available for knee pain management. Both t-RFA and C-RFA offer minimally invasive, non-surgical, non-opioid pain relief options following surgery. The study will perform a double-blinded, parallel grouped, placebo-controlled randomized study to compare three pain management paradigms involving preoperative genicular C-RFA, t-RFA, and control placebo/sham. The aim of this study is to establish if C-RFA and t-RFA, offered preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative pain relief.

Conditions

  • Osteoarthritis of the Knee

Interventions

PROCEDURE

t-RFA

standard thermal genicular radiofrequency ablation

PROCEDURE

C-RFA

Cooled radiofrequency ablation

PROCEDURE

Control

Simulated radiofrequency ablation for placebo controlled group

Sponsors & Collaborators

  • Halyard Health

    collaborator INDUSTRY

  • Lyman Medical Research Foundation, Inc.

    lead OTHER

Principal Investigators

  • Jeffrey Lyman, MD · Orthopedic Specialty Institute

  • Timothy Lovell, MD · Providence Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-25
Primary Completion
2020-01-07
Completion
2020-02-07

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 NCT02925442 on ClinicalTrials.gov