Pain Control With Pre-operative Cryoneurolysis Following TKA



Status:Recruiting
Conditions:Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 90
Updated:1/31/2019
Start Date:February 1, 2019
End Date:December 2019
Contact:Mitzi S Laughlin, PHD
Email:Mitzi.Laughlin@fondren.com
Phone:713-799-2300

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
1
site
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials