Pain Control With Pre-operative Cryoneurolysis Following TKA

Fondren Orthopedic Group L.L.P.

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Osteo Arthritis Knee

Interventions

Cryoneurolysis (Iovera)PROCEDURE

Cryoneurolysis performed by radiology department 1 week prior to total knee arthroplasty

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Fondren Orthopedic Group, L.L.P.

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: up to 3 months

Secondary Outcomes

Number of subject with an adverse effect from treatment

Any complication during treatment will be recorded.

Time frame: up to 3 months

Range of motion

During clinical office visits, your ability to bend and straighten your knee will be recorded.

Time frame: up to 3 months

Knee function

During clinical office visits, your ability to perform daily activities with regards to your knee will be recorded.

Time frame: up to 3 months

Knee swelling

The amount of swelling in your knee will be recorded.

Time frame: up to 3 months

Data from ClinicalTrials.gov

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