Genicular Radiofrequency Ablation for Unilateral Knee Arthroplasty Pain Management (RFA)

May 22, 2019 updated by: Lyman Medical Research Foundation, Inc.

Comparison Between Cooled (C-RFA) and Standard (t-RFA) Radiofrequency Ablation, and Control for Pain Management Following Unilateral Knee Arthroplasty: A Double-Blinded, Parallel-Grouped, Placebo-Controlled Randomized Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Total knee replacements are a leading orthopedic procedure in the United States totaling 600,000 in 2010, and are anticipated to grow to 3.48 million procedures by 2030. Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Reducing opioid usage and decreasing hospital length of stays are paramount in improving patient care during recovery and rehabilitation, subsequently reducing overall costs associated with total knee replacement. 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), which was previously used for spinal pain, is now available for knee pain management. C-RFA, compared to t-RFA, causes large volume spherical lesions and potentially reduces time and fluoroscopic exposure with direct placement techniques. However, both t-RFA and C-RFA offer a minimally invasive, non-surgical, non-opioid pain relief options following surgery. Preliminary reports involving 40 patients who underwent either C-RFA or t-RFA prior to unilateral knee arthroplasty by the investigator indicate both procedures improved postoperative pain assessments and decreased opioid/narcotic utilization. The study will perform a double-blinded, parallel grouped, placebo-controlled randomized study to compare three pain management paradigms involving preoperative C-RFA, t-RFA, and 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, reduce hospital length of stays and decrease opioid utilization thereby improving patient outcomes and decreasing overall costs.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Orthopedic Specialty Institute
    • Washington
      • Spokane, Washington, United States, 99202
        • Orthopedic Specialty Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Osteoarthritis of the knee where unilateral knee arthroplasty is indicated by radiograph, function decrease and/or pain indication and readiness to undergo t-RFA, C-RFA or sham treatment.

Exclusion Criteria:

□ • NO DAILY OPIOID CONSUMPTION 5 WEEKS PRIOR TO ENROLLMENT

  • NO DOCUMENTED NARCOTIC DEPENDENCY OR RECREATIONAL DRUG USE
  • NO TOBACCO USAGE WITHIN 2 MONTHS PRIOR TO SURGERY
  • NO CONFOUNDING INFLAMMATORY ARTHRITIS DISEASES ARE PRESENT
  • NO NEUROPATHY OR NEURO IMPAIRMENT PRESENT
  • NO SIGNIFICANT ACUTE ILLNESS OR INFECTION
  • NO OTHER CONFOUNDING CHRONIC PAIN
  • NO INVESTIGATIONAL AGENT WITHIN 3 MONTHS PRIOR TO ENROLLMENT
  • NO DIAGNOSED THROMBOPHILIA
  • NO SEVERE CARDIAC OR PULMONARY COMPROMISE
  • NO BLEEDING DISORDER(S)
  • NO ALLERGIC REACTION TO LOCAL ANESTHESIA, STEROIDS, OR IMPLANT MATERIALS
  • NO BREASTFEEDING
  • NO PREGNANCY
  • NO CONFOUNDING PSYCHIATRIC ILLNESSES
  • NO CONFOUNDING MAJOR TRAUMA HARDWARE REMOVALS OR PRIOR TKA *NO CONTRAINDICATED BODY HABITUS TO BE DETERMINED BY A TREATMENT PROVIDER

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Thermal radiofrequency ablation
Patients randomized to t-RFA will receive standard genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty for postoperative pain management.
Procedure: t-RFA
standard thermal genicular radiofrequency ablation
Other Names:
  • Standard thermal genicular radiofrequency ablation
Experimental: Cooled radiofrequency ablation
Patients randomized to C-RFA will receive cooled genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty for postoperative pain management.
Procedure: C-RFA
Cooled radiofrequency ablation
Other Names:
  • Coolief radiofrequency ablation
Sham Comparator: Control:Placebo Sham
Patients randomized to control will receive simulated genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty and receive the industry standard of care for unilateral knee arthroplasty pain management.
Procedure: Control
Simulated radiofrequency ablation for placebo controlled group
Other Names:
  • Placebo Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative analgesic consumption
Time Frame: 0 - 3 weeks postoperatively
Measure opioid consumption for the three study arms
0 - 3 weeks postoperatively
Hospital Length of Stay (LOS)
Time Frame: 0-5 days postoperatively
Measure hospital length of stay for the three study arms
0-5 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: before treatment arm procedures to 12 months after unilateral knee arthroplasty
assess patient pain score diaries after total knee replacement for the three treatment arms
before treatment arm procedures to 12 months after unilateral knee arthroplasty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lyman Medical Research Foundation, Inc.

Collaborators

Halyard Health

Investigators

  • Principal Investigator: Jeffrey Lyman, MD, Orthopedic Specialty Institute
  • Principal Investigator: Timothy Lovell, MD, Providence Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2017

Primary Completion (Anticipated)

January 7, 2020

Study Completion (Anticipated)

February 7, 2020

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSI-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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