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

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ClinicalTrials.gov Identifier: NCT02925442
Recruitment Status : Active, not recruiting
First Posted : October 5, 2016
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
Halyard Health
Information provided by (Responsible Party):
Lyman Medical Research Foundation, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Procedure: t-RFA Procedure: C-RFA Procedure: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Genicular radiofrequency ablation performed prior to total knee arthroplasty for pain management
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 25, 2017
Estimated Primary Completion Date : January 7, 2020
Estimated Study Completion Date : February 7, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Placebo Sham




Primary Outcome Measures :
  1. Postoperative analgesic consumption [ Time Frame: 0 - 3 weeks postoperatively ]
    Measure opioid consumption for the three study arms

  2. Hospital Length of Stay (LOS) [ Time Frame: 0-5 days postoperatively ]
    Measure hospital length of stay for the three study arms


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925442


Locations
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United States, Idaho
Orthopedic Specialty Institute
Coeur d'Alene, Idaho, United States, 83814
United States, Washington
Orthopedic Specialty Institute
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Lyman Medical Research Foundation, Inc.
Halyard Health
Investigators
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Principal Investigator: Jeffrey Lyman, MD Orthopedic Specialty Institute
Principal Investigator: Timothy Lovell, MD Providence Medical Center

Publications:
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Responsible Party: Lyman Medical Research Foundation, Inc.
ClinicalTrials.gov Identifier: NCT02925442     History of Changes
Other Study ID Numbers: OSI-0002
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lyman Medical Research Foundation, Inc.:
Unilateral Knee Arthroplasty
Radiofrequency Ablation
Genicular
RFA
C-RFA
t-RFA
total knee replacement

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases