Genicular Radiofrequency Ablation for Unilateral Knee Arthroplasty Pain Management

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Procedure: t-RFA
* Procedure: C-RFA
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Genicular radiofrequency ablation performed prior to total knee arthroplasty for pain management
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Thermal radiofrequency ablation<br>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<br>* standard thermal genicular radiofrequency ablation<br>* Other names: Standard thermal genicular radiofrequency ablation;|
| Experimental: Cooled radiofrequency ablation<br>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<br>* Cooled radiofrequency ablation<br>* Other names: Coolief radiofrequency ablation;|
| Sham Comparator: Control:Placebo Sham<br>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<br>* Simulated radiofrequency ablation for placebo controlled group<br>* Other names: Placebo Sham;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesic consumption | Measure opioid consumption for the three study arms | 0 - 3 weeks postoperatively | 
| Hospital Length of Stay (LOS) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unilateral Knee Arthroplasty, Radiofrequency Ablation, Genicular, RFA, C-RFA, t-RFA, total knee replacement