Preop Cooled Radiofrequency Ablation for Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
Total knee replacement surgery is commonly performed for patients suffering from severe knee osteoarthritis. However, 20% of patients continue to experience pain after surgery. There is currently no standardized pain management protocol for pain after total knee replacement. Cooled radiofrequency ablation has been used successfully to alleviate spin-related pain and has recently been approved by the FDA to treat chronic knee arthritic pain. This pilot study aims to collect preliminary data on the use of cooled radiofrequency ablation in patients undergoing total knee replacement.

Detailed Description
-----------------
The number of patients who undergo total knee replacement is rising significantly. However, many of these patients are dissatisfied with the results, because they continue to experience pain postoperatively. This pain can be debilitating and can also be associated with decreased quality of life. Given the increasing number of patients undergoing total knee replacement and a dissatisfaction rate of 8-44%, improvements must be made in pain management protocols to help decrease pain in the immediate postoperative period following total knee replacement. Cooled radiofrequency ablation is a procedure that uses water-cooled technology to denervate the sensory nerves. It is widely used in the spine and is increasingly being used in the knee to treat osteoarthritis. Existing studies have shown that it can significantly reduce pain in patients with chronic osteoarthritis. In terms of its potential benefit as a preoperative measure to minimize postoperative pain, the literature is sparse. Results from this study will be used to generate hypotheses and power for future studies.

Official Title
-----------------
A Pilot Study on the Utility of Cooled Radiofrequency Ablation in Patients Prior to Total Knee Arthroplasty

Conditions
-----------------
Postoperative Pain, Knee Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Total knee replacement
* Device: COOLIEF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing unilateral primary total knee replacement for osteoarthritis Pain >6 (on a scale of 0-10) Body mass index: 21-35 kg/m2 Exclusion Criteria: Age <65 years Patients who are wheelchair bound History of inflammatory arthritis or rheumatic disease Body mass index <21 or >35 kg/m2 Chronic opioid use Pregnant women Non-English speaking

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preoperative cooled radiofrequency ablation<br>Patients who undergo cooled radiofrequency ablation within 4-8 weeks of their scheduled total knee replacement. | Procedure: Total knee replacement<br>* Patients will undergo total knee replacement surgery.<br>Device: COOLIEF<br>* The superior lateral genicular nerve, superior medial genicular nerve, and inferior medial geniculate nerve will be ablated.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain will be assessing on a 0-10 scale, where 0=no pain and 10=most pain. | Up to 1 year post-total knee replacement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Disability | Knee disability will be assessed using the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR). The score ranges from 0-100, where 0=total knee disability and 10=perfect health. | Up to 1 year post-total knee replacement | 
| Function assessed using the PROMIS-physical function computer adaptive test | Function will be assessed using the PROMIS-physical function computer adaptive test. A higher score indicates higher function. | Up to 1 year post-total knee replacement |