Pain Control With Pre-operative Cryoneurolysis Following TKA

Last updated: February 22, 2024
Sponsor: Fondren Orthopedic Group L.L.P.
Overall Status: Trial Not Available

Phase

N/A

Condition

Osteoarthritis

Treatment

Cryoneurolysis (Iovera)

Clinical Study ID

NCT03818022
TOH180
  • Ages 18-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • any patient scheduled for primary total knee arthroplasty(TKA)

Exclusion

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 orpost-operative clinical visits
  • Patients whose insurance would deny payment for the cryoneurolysis treatment
  • Pregnant patients
  • Patients unable to speak and read English

Study Design

Treatment Group(s): 1
Primary Treatment: Cryoneurolysis (Iovera)
Phase:
Study Start date:
February 01, 2019
Estimated Completion Date:
December 31, 2020

Study 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.

Connect with a study center

  • Fondren Orthopedic Group, L.L.P.

    Houston, Texas 77030
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.