Pain Control With Pre-operative Cryoneurolysis Following TKA
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|ClinicalTrials.gov Identifier: NCT03818022|
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteo Arthritis Knee||Procedure: Cryoneurolysis (Iovera)||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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|
- 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.
- 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.
- Number of subject with an adverse effect from treatment [ Time Frame: up to 3 months ]Any complication during treatment will be recorded.
- Range of motion [ Time Frame: up to 3 months ]During clinical office visits, your ability to bend and straighten your knee will be recorded.
- 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.
- Knee swelling [ Time Frame: up to 3 months ]The amount of swelling in your knee will be recorded.
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 ClinicalTrials.gov identifier (NCT number): NCT03818022
|Contact: Mitzi S Laughlin, PHD||713-799-2300||Mitzi.Laughlin@fondren.com|
|United States, Texas|
|Fondren Orthopedic Group, L.L.P.||Recruiting|
|Houston, Texas, United States, 77030|