Clinical trial NCT03818022: Pain Control With Pre-operative Cryoneurolysis Following TKA
Official title: Effectiveness of Preoperative Cryoneurolysis (Iovera) for Postoperative Pain Control in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: knee
joint replacement
total knee
cryoneurolysis
Iovera
TKA
pain
Lead sponsor: Fondren Orthopedic Group L.L.P.
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Veterans Rand-12 (VR-12)
timeFrame: up to 3 months
measure: Knee Injury and Osteoarthritis Outcomes Survey (KOOS Jr)
timeFrame: up to 3 months
Secondary outcomes:
measure: Number of subject with an adverse effect from treatment
timeFrame: up to 3 months
measure: Range of motion
timeFrame: up to 3 months
measure: Knee function
timeFrame: up to 3 months
measure: Knee swelling
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Fondren Orthopedic Group, L.L.P.
state: Texas
Study officials:
References: