Pain Control With Pre-operative Cryoneurolysis Following TKA

Study Overview
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Brief Summary
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The purpose of this study is to assess the potential benefit of preoperative cryoneurolysis in postoperative pain management of total knee arthroplasty patients over current pain management protocol.

Detailed Description
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Cryoneurolysis, is a novel technique that can yield temporary blockade of superficial sensory nerves, generating immediate and meaningful relief of pain.The technique generates an axonotmesis of the targeted peripheral nerves by percutaneously applying low temperatures (-100 °C to -20 °C). Wallerian degeneration is produced whereby the axons and the myelin sheath are damaged but the endoneurium, perineurium and epineurium remain intact. Therefore, permanent damage to the nerve is avoided as it retains its regenerative properties. With regards to the knee, the infrapatellar branch of the saphenous nerve (IPBSN), a sensory branch serving both the inferior and anterior portion of the knee capsule and the antero-medial skin of the knee is the prime target for the procedure. Your participation in this study requires that you allow the radiology department of Texas Orthopedic Hospital to administer Cryoneurolysis using the Iovera device with the functional smart tip approximately 1 week prior to total knee arthroplasty surgery. A highly localized cold zone is created via the Joule-Thompson effect as nitrous oxide enters the needles. Nothing is injected into the body and the nitrous oxide gas is vented safely out of the handpiece. Cryoneurolysis is administered following local anesthesia.

Official Title
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Effectiveness of Preoperative Cryoneurolysis (Iovera) for Postoperative Pain Control in Total Knee Arthroplasty

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Procedure: Cryoneurolysis (Iovera)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: any patient scheduled for primary total knee arthroplasty(TKA) Exclusion Criteria: Bilateral TKA (patients routinely receive spinal anesthesia) Minors Patients reporting a history of Raynaud's disease Patients with an open and/or infected wound on surgical knee Patients who are taking opioids during the pre-operative period due to knee pain Patients who cannot return for the cryoneurolysis treatment 7 days prior to surgery or post-operative clinical visits Patients whose insurance would deny payment for the cryoneurolysis treatment Pregnant patients Patients unable to speak and read English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patients receiving Cryoneurolysis (Iovera) prior to total knee arthroplasty | Procedure: Cryoneurolysis (Iovera)<br>* Cryoneurolysis performed by radiology department 1 week prior to total knee arthroplasty<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Veterans Rand-12 (VR-12) | VR-12 is a 12 item questionnaire that measures health related quality of life. Scores range from 0 to 100 with 50 being an average score and higher scores representing better health related quality of life. | up to 3 months | 
| Knee Injury and Osteoarthritis Outcomes Survey (KOOS Jr) | KOOS Jr. is a short questionnaire that evaluates knee pain and function. Scores range from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health. | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subject with an adverse effect from treatment | Any complication during treatment will be recorded. | up to 3 months | 
| Range of motion | During clinical office visits, your ability to bend and straighten your knee will be recorded. | up to 3 months | 
| Knee function | During clinical office visits, your ability to perform daily activities with regards to your knee will be recorded. | up to 3 months | 
| Knee swelling | The amount of swelling in your knee will be recorded. | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, joint replacement, total knee, cryoneurolysis, Iovera, TKA, pain