Study to Evaluate Iovera®° in Adult Patients Undergoing Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT04191031|
Recruitment Status : Not yet recruiting
First Posted : December 9, 2019
Last Update Posted : July 27, 2020
Primary objective: The primary objective of this study is to evaluate either a) the postsurgical total opioid consumption or b) 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). A single primary objective, either a or b, will be declared by an unblinded Independent Review Committee (IRC) in an interim analysis after 30 randomized and treated subjects complete the Day 42 assessments. The primary objective not selected will be placed in the secondary objectives category.
Secondary objectives: The secondary objectives of this study are to compare postsurgical pain control or postsurgical total opioid consumption (whichever is not chosen as the primary objective), 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
|Condition or disease||Intervention/treatment||Phase|
|Post-Operative Pain Management||Device: ioveraº Device: ioveraº sham||Not Applicable|
This is a multicenter, prospective, randomized, double blind, sham controlled study in adult subjects undergoing TKA.
Subjects will be screened no more than 60 days prior to TKA. During the screening visit, subjects will be assessed for past or present neurologic, cardiac, and general medical conditions that, in the opinion of the Investigator, would preclude them from study participation. No procedures other than the site's standard of care will be performed before signed informed consent is obtained. After the informed consent form (ICF) is signed, demographic information, medical and surgical history, concomitant medications/concurrent procedures information and vital signs will be collected. Assessment of the intended treatment areas, functional-ability assessments, a urine drug screen, and a urine pregnancy test (UPT) for women of childbearing potential will be conducted.
Randomization: initially 60 subjects will be randomized 1:1 (30 subjects per group) to one of two treatment groups.
Group 1: 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
Group 2: subjects will receive sham iovera° treatment of superficial genicular nerves (AFCN and ISN) of the target knee
All subjects in all groups will also receive intraoperative local infiltration with EXPAREL and postoperative multimodal pain medications.
Based on the results of an interim analysis, a primary endpoint between a) the postsurgical total opioid consumption or b) postsurgical pain control will be chosen and additional subjects may be enrolled (up to an estimated target of 200 subjects in total)..
Subjects will be asked questions and/or be asked to fill forms as part of the following assessments: Numeric Rating Scale (NRS) to assess pain scores and sleep quality, functional (physical) ability tests to assess range of motions, and KOOS questionnaire to assess knee movement.
iovera° treatment or iovera° sham treatment (Day -15 [±7 days] prior to TKA). TKA surgery will be Day 1 and follow up will be up to Day 90. Therefore, subjects may participate in the study for up to 155 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Estimated Study Start Date :||August 2020|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||May 2021|
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
Device: ioveraº sham
- Total opioid consumption in oral morphine equivalent dose from TKA (Day 1) to Day 42 (6 weeks post-TKA) [ Time Frame: Day 1 to Day 42 ]
- The area under the curve (AUC) of the Numeric Rating Scale (NRS) "worst pain" intensity scores from TKA (Day 1) to Day 42 (6 weeks post-TKA) [ Time Frame: Day 1 to Day 42 ]NRS scale is 0 to 10 with 0 being no pain and 10 being the worst pain
- Numeric Rating Scale (NRS) pain intensity scores "right now" at Day 15, 30, 42, and Day 90 [ Time Frame: Day 15 to Day 90 ]NRS scale is 0 to 10 with 0 being no pain and 10 being the worst pain
- Numeric Rating Scale (NRS) pain intensity scores "average pain" at Day 4 to Day 42 [ Time Frame: Day 4 to Day 42 ]NRS scale is 0 to 10 with 0 being no pain and 10 being the worst pain
- Total opioid consumption in oral morphine equivalents from TKA-Day 15, TKA-Day 30, TKA-Day 42, and TKA-Day 90 [ Time Frame: Day 1 to Day 90 ]
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): NCT04191031
|Contact: Christine Brozyniakemail@example.com|
|Contact: Kim Hunsicker, MSN, CRNP, MBA||973-254-4361||Kim.Hunsicker@pacira.com|
|Study Director:||Nayana Nagaraj, MD, PhD, MPH||Pacira Pharmaceuticals, Inc|