A Multicenter, Double-blind, Randomized, Sham-controlled Study Assessing Opioid Utilization, Postoperative Pain and Function in Subjects Undergoing Total Knee Arthroplasty Treated With Presurgical Iovera®° or Sham Iovera®° Cryoneurolysis and Postsurgical Multimodal Pain Regimen

Status: Active, not recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Primary objective: The primary objective of this study is to evaluate postsurgical pain control, after presurgical iovera° treatment plus EXPAREL® and standardized multimodal therapy compared with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy in subjects undergoing primary unilateral total knee arthroplasty (TKA). Secondary objectives: The secondary objectives of this study are to compare postsurgical pain control or postsurgical total opioid consumption, opioid-free status, physical function, sleep quality, and safety of presurgical iovera° treatment plus EXPAREL and standardized multimodal therapy with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy, in subjects undergoing primary unilateral TKA

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: No
View:

• Male or female, at least 22 years of age at screening.

• Scheduled to undergo primary, unilateral, tricompartmental TKA under spinal anesthesia.

• Primary indication for TKA is degenerative osteoarthritis of the knee.

• American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.

• Anticipation of discharge to home after inpatient acute postsurgical phase based on age, comorbidities, home environment, social support, and the judgment of the Investigator.

• Females of childbearing potential must have a negative pregnancy test result prior to enrollment and agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year). Post-menopausal or surgically sterile females would not require a pregnancy test.

• Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Locations
United States
California
Sah Orthopaedic Associates at the Institute for Joint Restoration
Fremont
Lotus Clinical Research
Pasadena
Florida
Phoenix Clinical Research
Tamarac
Maryland
Towson Orthopaedic Associates
Towson
New York
Northwell Health
New York
Texas
First Surgical Hospital
Bellaire
Legent Orthopedic Hospital
Carrollton
Time Frame
Start Date: September 30, 2020
Estimated Completion Date: September 29, 2022
Participants
Target number of participants: 200
Treatments
Experimental: Superficial Genicular Nerves
Subjects will receive iovera° cryoneurolysis treatment of superficial genicular nerves (anterior femoral cutaneous nerve [AFCN] and infrapatellar branches of the saphenous nerve [ISN]) of the target knee
Sham Comparator: Sham Comparator
Subjects will receive sham iovera° treatment of superficial genicular nerves (AFCN and ISN) of the target knee
Authors
Michael Mont, David Dalury, William Barrett, Naum Shaparin, Alexander Sah, Alina Beaton, Richard Berkowitz, Joseph Gimbel, J Richard Evanson, Daneshvari Solanki
Sponsors
Leads: Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.

This content was sourced from clinicaltrials.gov

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