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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and functional status in non-surgical patients with knee osteoarthritis as well as the high prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA. Patients will be randomized to one of two study arms: RFA group (genicular nerve thermal RFA) or control group (RFA needles placed in proper location without effective neurotomy).
Total knee arthroplasty (TKA) is a common and effective treatment for severe knee osteoarthritis. As the average age of the population increases in developed countries, the number of TKAs performed is projected to increase to 3.48 million procedures per year by 2030, a 673% increase from 2005. Although TKA is widely accepted as an efficacious form of treatment for severe knee osteoarthritis, the incidence of patient dissatisfaction and postoperative pain cannot be ignored. Genicular nerve RFA has been performed in non-surgical patients with chronic knee osteoarthritis with significant post procedure improvement in pain and functional status. This study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA Group | Experimental | A genicular nerve RFA will be performed prior to planned total knee arthroplasty. |
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| Control Group | Sham Comparator | A sham genicular nerve RFA will be performed prior to planned total knee arthroplasty. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genicular Nerve RFA | Procedure | Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. RFA probes will be placed and connected to the RFA generator and the generator is activated. The RFA is performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of pain score at rest | Pain score at rest using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) | On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52. |
| Comparison of pain score with ambulation | Pain score with ambulation using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) | On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of PROMIS physical function score | Physical function assessment using the PROMIS physical function score | On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52 |
| Comparison of PROMIS global health score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Puneet Mishra, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26488691 | Background | Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467. | |
| 20823375 | Background | Singh JA, Vessely MB, Harmsen WS, Schleck CD, Melton LJ 3rd, Kurland RL, Berry DJ. A population-based study of trends in the use of total hip and total knee arthroplasty, 1969-2008. Mayo Clin Proc. 2010 Oct;85(10):898-904. doi: 10.4065/mcp.2010.0115. Epub 2010 Sep 7. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| Sham Genicular Nerve RFA | Procedure | Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. The RFA probes for the control group will not be connected to the RFA generator (no neurotomy); however, the generator will still be activated to mimic the RFA group. |
|
Global health assessment using the PROMIS global health score |
| On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52 |
| Comparison of Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR) | Outcome assessment using the Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR) | On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52 |
| Comparison of 7-point Patient Global Impression of Change (PGIC) | Assessment of the subject's belief about the efficacy of treatment using the PGIC. | Preoperatively on the day of surgery, and at week 2, 6, 24, and 52 |
| Comparison of Mobility using Timed Up and Go Test (TUG) | Assessment of mobility using the TUG test | Day of genicular RFA or sham procedure, and postoperative day 1 |
| Comparison of Depression assessment using Center for Epidemiologic Studies Depression Scale (CES-D) | Screening for depression using the CES-D | Day of genicular RFA or sham procedure and at 6 weeks postoperatively |
| Comparison of Total opioid use in morphine equivalents | Day of genicular RFA or sham procedure, day of surgery, post op dy 1 and 2, and at weeks 2,6 postoperatively |
| Assessment of pain location using Michigan Body Map | Day of genicular nerve RFA |
| Assessment of pain catastrophizing using Catastrophizing General Chronic Pain (CAT) Scale | Day of genicular RFA or sham procedure |
| Comparison of quadriceps strength | Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively |
| Comparison Range of Motion - Knee | Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively |
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| 17403800 | Background | Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222. |
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| 21402445 | Background | Srikandarajah S, Gilron I. Systematic review of movement-evoked pain versus pain at rest in postsurgical clinical trials and meta-analyses: a fundamental distinction requiring standardized measurement. Pain. 2011 Aug;152(8):1734-1739. doi: 10.1016/j.pain.2011.02.008. Epub 2011 Mar 12. |
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| 34215667 | Derived | Mishra P, Edwards D, Huntoon M, Sobey C, Polkowski G, Corey J, Mishra KL, Shinar A, Engstrom S, Palmer C, Bruehl S. Is preoperative genicular radiofrequency ablation effective for reducing pain following total knee arthroplasty? A pilot randomized clinical trial. Reg Anesth Pain Med. 2021 Sep;46(9):752-756. doi: 10.1136/rapm-2021-102501. Epub 2021 Jul 2. |