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

NCT04191031 | Terminated FDA Device

• 1 other identifier: IOV-401
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

Post-Operative Pain Management

Keywords

Total Knee Arthroplasty; Osteoarthritis; Iovera

Outcome Measures

Primary Outcomes (1)

• NRS "worst pain" intensity scores from first pain assessment post-TKA (Day 1) to Day 30.

  Day 1 to Day 30

Secondary Outcomes (12)

• Change of KOOS scores (English version LK 1.0) from TKA Pre-Surgery visit to Day 30 visit post-TKA

  Day -3 to Day 30

• NRS "worst pain" intensity scores from first pain assessment post-TKA (Day 1) to Day 15, Day 42, and Day 90.

  Day 1 to Day 90

• NRS "average pain" intensity scores from first pain assessment post-TKA (Day 1) to Day 15, Day 30, Day 42, and Day 90

  Day 1 to Day 90

• Change of NRS current pain intensity scores (pain "right now") from pre-treatment to post-treatment at the iovera/sham treatment visit

  Day 1 to Day 90

• Total postsurgical opioid consumption in oral morphine equivalents through Day 15, Day 30, Day 42, and Day 90

  Day 1 to Day 90

Study Arms (2)

Superficial Genicular Nerves

EXPERIMENTAL

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

Device: ioveraº

Sham Comparator

SHAM COMPARATOR

Subjects will receive sham iovera° treatment of superficial genicular nerves (AFCN and ISN) of the target knee

Device: ioveraº sham

Interventions

ioveraº DEVICE

Cryoneurolysis

Superficial Genicular Nerves

ioveraº sham DEVICE

ioveraº sham

Sham Comparator

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of prior contralateral TKA within 6 months or open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted.
• Planned concurrent surgical procedure (e.g., bilateral TKA) or planned additional surgery within 90 days of study surgery.
• Undergoing unicompartmental TKA or revision TKA.
• Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the knee surgery and which may confound the postsurgical assessments (e.g., significant pain from other joints including the non-index knee joint, chronic neuropathic pain, concurrent or prior contralateral TKA, concurrent foot surgery).
• Comorbidity that, in the judgment of the Investigator, may affect the subject's ability to participate in the study and postsurgical rehabilitation.
• Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications (i.e., bupivacaine, lidocaine, acetaminophen, tranexamic acid, celecoxib, naproxen, meloxicam).
• Use of any of the following medications within the times specified before TKA: long-acting and short-acting opioid medications within 6 weeks; or NSAIDs (except for low-dose aspirin used for cardioprotection) within 3 days or 5 elimination half-lives, whichever is longer.
• Initiation of treatment with any of the following medications within 1 month prior to the screening visit or ongoing concomitant use if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, he or she must be on a stable dose for at least 1 month prior to screening visit.
• Current use of systemic glucocorticosteroids within 1 month prior to screening in this study, intra-articular corticosteroid injections within 6 weeks, or Zilretta within 3 months.
• History of coronary or vascular stent placed within the past 6 months (may be extended to 1 year if medically indicated per physician discretion).
• Have been treated for a deep vein thrombosis, pulmonary embolism, myocardial infarction, or ischemic stroke within the past 6 months (may be extended to 1 year if medically indicated per physician discretion).
• Any clotting disorder and/or use of an anticoagulant (e.g. warfarin, clopidogrel, etc.) within seven (7) days prior to administration of ioveraº treatment.
• Rheumatoid or inflammatory arthritis.
• History of severely impaired renal or hepatic function (in the judgment of the investigator).
• Any neurologic or psychiatric disorder that might affect postsurgical pain or interfere with study assessments.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (7)

Sah Orthopaedic Associates at the Institute for Joint Restoration

Fremont, California, 94538, United States

Location

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Phoenix Clinical Research

Tamarac, Florida, 33321, United States

Location

Towson Orthopaedic Associates

Towson, Maryland, 21204, United States

Location

Northwell Health

New York, New York, 10075, United States

Location

First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

Legent Orthopedic Hospital

Carrollton, Texas, 75006, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Gary Nevins, DC

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 9, 2019
• Study Start: September 30, 2020
• Primary Completion: May 13, 2022
• Study Completion: July 12, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)