A Randomized, Study to Evaluate the Iovera° Device in Treating Pain Associated With Total Knee Arthroplasty
- Conditions
- Arthritis of the Knee
- Interventions
- Device: iovera°Device: iovera° Sham
- Registration Number
- NCT02284113
- Lead Sponsor
- Pacira Pharmaceuticals, Inc
- Brief Summary
This study will evaluate the iovera° device in treating pain associated with total knee arthroplasty (TKA). This study will also assess if overall pain medication is reduced following TKA and will investigate the relationship between patients treated with the iovera° device and length of hospital stay, pain, patient satisfaction and improved rehabilitation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 22 to 79 years of age
- Scheduled to undergo primary unilateral TKA under spinal anesthesia for primary diagnosis of osteoarthritis
- American Society of Anesthesiology (ASA) Physical Classification System classes I-III
- Anticipation of discharge to home after inpatient acute post-op phase (age, co-morbidities, home environment, and social support are in favor of discharge to home in the opinion of the Investigator)
- Subject is willing and able to give written informed consent.
- Subject is fluent in verbal and written English.
- Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
- Subject is in good general health and free of any systemic disease state or physical condition that might impair evaluation or which in the Investigator's opinion, exposes the Subject to an unacceptable risk by study participation.
Exclusion Criteria
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months).
- Concurrent painful physical condition, surgery, or musculoskeletal disease that requires or may require analgesic treatment during study follow-up that is not strictly related to the target knee being treated with iovera°, which have the potential to confound the postoperative assessments (e.g., significant pain from other joints, chronic neuropathic pain, concurrent or planned contralateral TKA, concurrent foot, neck, spine, hip, or other musculoskeletal disease, arthritis, or planned surgery, etc.).
- Greater than 15° malalignment (varus or valgus) on pre-operative radiograph.
- Previous myoscience FCT™ treatment.
- Previous Partial or Total Knee Arthroplasty. Partial or Total Knee Arthroplasty of the contralateral knee is permitted if [surgery was completed at least twelve (12) months prior to screening].
- Body Mass Index ≥ 40
- Prior surgery in the treatment areas that may alter the anatomy of the infrapatellar branch of the saphenous nerve (ISN) or the anterior femoral cutaneous nerve (AFCN) or result in scar tissue in the treatment area.
- Any clotting disorder and/or use of an anticoagulant (e.g. warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the device. Low dose aspirin (81mg or less daily) for cardiac prophylaxis allowed.
- Any local skin condition at the treatment sites that in the Investigator's opinion would adversely affect treatment or outcomes.
- Open and/or infected wound in the treatment areas.
- Allergy to lidocaine.
- History of cryoglobulinemia
- History of paroxysmal cold hemoglobinuria.
- History of cold urticaria.
- History of Raynaud's disease.
- History of opioid or alcohol abuse.
- Subject is pregnant or planning to become pregnant while enrolled in the study.
- Current enrollment in any investigational drug or device study or participation within 30 days prior to screening.
- Currently being treated for related knee injury under worker's compensation claim or equivalent (i.e. legal case).
- Any chronic medical condition that in the Investigator's opinion would prevent adequate participation.
- Any chronic medication use (prescription, over-the-counter, etc.) that in the Investigator's opinion would affect study participation or Subject safety.
- For any reason, in the opinion of the Investigator, the Subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, etc.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment iovera° Treatment with focused cold therapy. Sham iovera° Sham Sham treatment with focused cold therapy device
- Primary Outcome Measures
Name Time Method Cumulative Consumption of Opioids Total Daily Morphine Equivalent (TME) (mg/Day) hospital discharge to 6 Weeks post-TKA surgery The cumulative morphine equivalent was divided by the number of days to provide a Total Daily Morphine Equivalent (TME) for each Subject.
- Secondary Outcome Measures
Name Time Method 40 Meter Walk Test Baseline, 2,4,6,12 weeks The 40 Meter Walk Test measured the average speed in meters per second a Subject could walk 40 meters.
Change in Pain From Baseline to Six Weeks Baseline to 6 Weeks The Numeric Rating Scale for Pain (NRS for Pain) is a measure of pain intensity which is assessed on a scale from 0 to 10 with 0 being no pain at all and 10 being the worst pain imaginable. The Subject provides a self-reported score based on their pain in the target knee at the time the questionnaire is administered (labeled 'now' in the tables below) as well as their pain in the past 7 days (labeled "past 7" in the tables below).
30 Second Chair Test Baseline, 2,4,6,12 weeks after surgery The 30 Second Chair Test evaluates physical function during recovery by measuring the number of times a subject could go from seated in a chair to standing over the course of 30 seconds.
Change in WOMAC Scores at 6 Weeks After Surgery Baseline to 6 weeks after surgery The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a tri-dimensional, disease-specific, Subject-reported outcome measure. It consists of 24 questions with 5 questions regarding pain, 2 questions regarding stiffness and 17 questions regarding function in Subjects with osteoarthritis of the hip and/or knee. Each question is answered on a scale of 0 (none)-10 (extreme). Higher scores are associated with worse outcomes.
Length of Hospital Stay treatment to hospital discharge Change 36-Item Short Form Health Survey (SF-36) From Baseline to 6 Weeks Baseline to Week 6 The 36-question survey captures the Subject's perception of their general health by sorting them into multi-item scales that assess eight health concepts rather than a single total score. The survey used ten components to assess the health concepts: Physical, Mental, Physical Functioning, Role- Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Health Transition. Subject responses to the SF-36 survey were recorded. Scores can range from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Change in Active Range of Motion From Baseline to 2 Weeks After Surgery baseline to 2 weeks after surgery Range of motion measures the physical function of the replaced knee during active flexion at the specified timepoints.
Change in Patient Reported Outcomes Measurement Information System (PROMIS) From Baseline to Week 6 Baseline to 6 weeks after surgery 8 domains assessing physical, mental and social health while also covering important areas of self-reported health: pain, fatigue, depression, anxiety, sleep, and physical function. A high PROMIS domain sub-score indicates more of that concept being measured. PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. The referent population is usually the US General Population. lower scores are less favorable, and higher scores are more favorable.
Trial Locations
- Locations (8)
Phoenix Clinical Research, LLC
🇺🇸Tamarac, Florida, United States
LSUHSC - Department of Orthopaedics
🇺🇸New Orleans, Louisiana, United States
Holy Cross Hospital Orthopedic Research Institute
🇺🇸Fort Lauderdale, Florida, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Rothman Institute
🇺🇸Philadelphia, Pennsylvania, United States
Colorado Orthopedic Consultants, P.C.
🇺🇸Englewood, Colorado, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
University of California San Diego
🇺🇸San Diego, California, United States