Pain Control With Pre-operative Cryoneurolysis Following TKA

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Procedure: Cryoneurolysis (Iovera)

Detailed Description

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Fondren Orthopedic Group, L.L.P.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondren Orthopedic Group L.L.P.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Estimated): December 1, 2020
• Study Completion (Estimated): December 1, 2020

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: pain; knee; TKA; joint replacement; total knee; cryoneurolysis; Iovera
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: TOH180

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No