Pain Control With Pre-operative Cryoneurolysis Following TKA
Effectiveness of Preoperative Cryoneurolysis (Iovera) for Postoperative Pain Control in Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- Fondren Orthopedic Group, L.L.P.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Experimental
Patients receiving Cryoneurolysis (Iovera) prior to total knee arthroplasty
|
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)
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.
|
up to 3 months
|
|
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.
|
up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of subject with an adverse effect from treatment
Time Frame: up to 3 months
|
Any complication during treatment will be recorded.
|
up to 3 months
|
|
Range of motion
Time Frame: up to 3 months
|
During clinical office visits, your ability to bend and straighten your knee will be recorded.
|
up to 3 months
|
|
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.
|
up to 3 months
|
|
Knee swelling
Time Frame: up to 3 months
|
The amount of swelling in your knee will be recorded.
|
up to 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TOH180
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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