Study 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
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 ioverao treatment plus EXPAREL® (bupivacaine liposome injectable suspension) and standardized multimodal therapy compared with presurgical sham ioverao 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 ioverao treatment plus EXPAREL and standardized multimodal therapy with presurgical sham ioverao treatment plus EXPAREL and standardized multimodal therapy in subjects undergoing primary unilateral TKA.
Study Status: Not yet recruiting
NCT Number: NCT04191031
Study Nickname: PREPARE
Up to 200
Post market study
Target Number of Sites: 7
Key Participation Criteria
Maximum of 90 days
Primary, unilateral, tricompartmental TKA under spinal anesthesia
- 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, co-morbidities, 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)
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments
- 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 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
- 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 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.
- Malignancy in the last 2 years, per physician discretion.
- History of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol within the past 2 years.
- Use of medical marijuana within 6 weeks prior to screening visit or continuation thereafter.
- Body weight <50 kg (110 pounds) or a body mass index >40 kg/m2.
- Previous ioverao treatment.
- Greater than 15o malalignment (varus or valgus) on presurgical radiograph.
- Prior surgery in the treatment areas that may have altered the anatomy of nerves intended to be treated with the ioverao system or result in scar tissue in the treatment area.
- Open and/or infected wounds at or near the treatment site.
- Any other local skin condition at the treatment sites that in the Investigator's judgment would adversely affect treatment or outcomes.
- History of cryoglobulinemia.
- History of paroxysmal cold hemoglobinuria.
- History of cold urticaria.
- History of Raynaud's disease.
- Administration of an investigational product within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to screening, or planned administration of another investigational product or procedure during the subject's participation in this study