Pain Control With Pre-operative Cryoneurolysis Following TKA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03818022
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 29, 2019
Information provided by (Responsible Party):
Fondren Orthopedic Group L.L.P.

Brief 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.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Procedure: Cryoneurolysis (Iovera) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effectiveness of Preoperative Cryoneurolysis (Iovera) for Postoperative Pain Control in Total Knee Arthroplasty
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

No Intervention: Control

Primary Outcome Measures :
  1. Veterans Rand-12 (VR-12) [ Time Frame: up to 3 months ]
    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.

  2. Knee Injury and Osteoarthritis Outcomes Survey (KOOS Jr) [ Time Frame: up to 3 months ]
    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.

Secondary Outcome Measures :
  1. Number of subject with an adverse effect from treatment [ Time Frame: up to 3 months ]
    Any complication during treatment will be recorded.

  2. Range of motion [ Time Frame: up to 3 months ]
    During clinical office visits, your ability to bend and straighten your knee will be recorded.

  3. Knee function [ Time Frame: up to 3 months ]
    During clinical office visits, your ability to perform daily activities with regards to your knee will be recorded.

  4. Knee swelling [ Time Frame: up to 3 months ]
    The amount of swelling in your knee will be recorded.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03818022

Contact: Mitzi S Laughlin, PHD 713-799-2300

United States, Texas
Fondren Orthopedic Group, L.L.P. Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Fondren Orthopedic Group L.L.P.

Responsible Party: Fondren Orthopedic Group L.L.P. Identifier: NCT03818022     History of Changes
Other Study ID Numbers: TOH180
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondren Orthopedic Group L.L.P.:
joint replacement
total knee

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases