Study to Evaluate Iovera®° in Adult Patients Undergoing Total Knee Arthroplasty

Post-Operative Pain Management Clinical Trial

Official title: 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 Terminated

Clinical Trial 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

Clinical Trial Description

This is a multicenter, double-blind, randomized, sham-controlled study in adult subjects undergoing TKA. Approximately 200 subjects are planned for enrollment and will be randomized 1:1 to receive presurgical ioveraº treatment or sham ioveraº treatment. An unblinded interim analysis will be performed when approximately 60 randomized and treated subjects have completed the Day 30 assessments. Based on the results of the interim analysis, sample size re-estimation will be performed and one of the following will occur: (1) the study will proceed to the final analysis without additional interim analysis, (2) the study will proceed to the second interim analysis once a defined number of additional subjects have completed Day 30 assessments, at which time, the study may be stopped for success or futility or proceed to the final analysis (3) the study will be stopped for futility. The detailed decision rules are defined in response to the interim analysis statistical analysis plan (IA SAP).

This study is designed to investigate whether presurgical iovera° cryoneurolysis treatment leads to less postsurgical opioid consumption, decreased pain after surgery, improved function, and improved postsurgical outcomes compared with subjects who undergo presurgical sham iovera° treatment. All subjects will receive postsurgical multimodal pain medications and intraoperative local infiltration with EXPAREL (bupivacaine liposome injectable suspension).

Subjects may be screened within 60 days prior to TKA. No procedures other than the site's standard of care will be performed before signed informed consent is obtained. When screening test results are received and the subject is deemed eligible for the study, the subject will be notified that he or she can be enrolled in the study.

Subjects may be rescreened upon sponsor approval for administrative reasons.

Randomization to treatment groups and treatment with the iovera° system according to the randomization assignment will be performed prior to TKA. The treatment groups are:

• Group 1: subjects will receive iovera° cryoneurolysis treatment of superficial genicular nerves of the target knee

• Group 2: subjects will receive sham iovera° treatment of superficial genicular nerves of the target knee

At the subsequent TKA, all subjects in both groups will receive intraoperative local infiltration with EXPAREL and postsurgical multimodal pain medications.

After discharge, subjects will be followed for 90 days. Subjects will be assessed for safety, efficacy, and health outcomes parameters. ;

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-Operative Pain Management

• NCT number: NCT04191031
• Study type: Interventional
• Source: Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.
• Status: Terminated
• Phase: N/A
• Start date: September 30, 2020
• Completion date: July 12, 2022