Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-22 @ 9:41 AM
Study NCT ID:
NCT01475604
Status:
TERMINATED
Last Update Posted:
2012-07-10
First Post:
2011-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-06', 'studyFirstSubmitDate': '2011-11-17', 'studyFirstSubmitQcDate': '2011-11-17', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The average daily morphine equivalent dose consumption at 2 weeks post-surgery.', 'timeFrame': '2-week follow-up period from surgery'}], 'secondaryOutcomes': [{'measure': 'Post-surgical opioid use during hospitalization and following discharge at 1 and 4 weeks post-surgery.', 'timeFrame': '1 and 4 weeks post-surgery'}, {'measure': 'Knee pain severity assessed on a 10 cm visual analogue scale (VAS)', 'timeFrame': 'At intervals over the 4-week follow-up period', 'description': 'Knee pain will be assessed for "current", pain at the time of data collection and "maximum", maximum pain experience at any point during the day of evaluation'}, {'measure': 'The measurement of knee joint circumference', 'timeFrame': 'Measurement performed preoperatively, on the first or second postoperative day, at the discharge dressing change, and at the 4 week follow-up visit', 'description': 'With patient in supine position, the circumference of the extended knee will be measured 1 cm proximal to the base of the patella using the same type of tape measure in all patients'}, {'measure': 'Range of motion of the knee joint, assessed using the knee flexion technique', 'timeFrame': 'Assessed preoperatively, on the first or second postoperative day, at the discharge dressing change (unless discharged within 2 days), and at the 4 week follow-up visit', 'description': 'Range of motion will be assessed using the knee flexion technique, which allows the use of a goniometer with the trans-epicondylar axis of the knee joint as the fulcrum.'}, {'measure': 'OA-related medication use including analgesics, anti-inflammatories, and other non-opioids', 'timeFrame': '4 weeks post-surgery', 'description': 'Subjects will be required to track daily OA-related medication use including analgesics, anti-inflammatories, and other non-opioids using a daily diary.'}, {'measure': 'Adverse Events collected and analyzed for confirmation of device safety', 'timeFrame': 'Randomization to 4 weeks post-surgery', 'description': 'Subjects will be instructed by the research staff and in the instructions in the daily diary to contact the research staff and/or investigator with any adverse events (AEs). Adverse events will be recorded daily.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulsed Radio Frequency, Electromagnetic Field therapy'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of pulsed radio frequency (PRF), a type of electromagnetic field treatment with the Ivivi Torino II for reducing post-operative narcotic use in patients recovering from Total Knee Arthroplasty.', 'detailedDescription': 'Surgeons are continually looking for means to minimize postoperative pain following TKA in order to reduce or eliminate the need for opioid pain medications. Reductions in pain and edema along with improvements in range of motion encourage quicker recovery of joint function and normal activities. Pulsed radio frequency (PRF), a type of electromagnetic field treatment is proven to effectively modulate postoperative pain and edema in plastic surgery. Therefore, PRF has potential as an adjunct therapy for patients recovering from TKA.\n\nThe purpose of the current double-blind, randomized, sham-controlled clinical trial is to determine the effectiveness and safety of the Ivivi Torino II, a device that delivers pulsed radio frequency (PRF), a type of electromagnetic field treatment, in patients recovering from TKA for treatment of severe knee OA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40 to 80 years\n* Primary diagnosis of knee OA\n* Appropriate candidate for TKA\n* Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects\n* Consent to the study and willing to comply with study product and methods including follow-up\n\nExclusion Criteria:\n\n* Body mass index \\> 40 kg/m2\n* Scheduled for bilateral TKA\n* Advanced hip, spine, or ankle osteoarthritis that significantly limits ambulation\n* Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator)\n* Use of narcotic pain medication for any condition in the last 1 month prior to surgery\n* Self-reported diagnosis of post-traumatic or inflammatory arthritis (e.g. rheumatoid or psoriatic)\n* Pregnant or lactating female\n* Participation in any clinical trial in the past 30 days\n* Vulnerable populations including prisoners and nursing home residents\n* Any medical condition that, in the opinion of the investigator, may compromise patient safety or confound the assessment of treatment effectiveness'}, 'identificationModule': {'nctId': 'NCT01475604', 'briefTitle': 'Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amp Orthopedics, Inc.'}, 'officialTitle': 'Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty: A Double-Blind, Randomized, Sham-controlled Trial', 'orgStudyIdInfo': {'id': 'IOH-TKA-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Targeted pulsed electromagnetic field', 'interventionNames': ['Device: Ivivi Torino II']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'interventionNames': ['Device: Ivivi Torino II']}], 'interventions': [{'name': 'Ivivi Torino II', 'type': 'DEVICE', 'otherNames': ['Electromagnetic Field Therapy'], 'description': 'Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery', 'armGroupLabels': ['Targeted pulsed electromagnetic field']}, {'name': 'Ivivi Torino II', 'type': 'DEVICE', 'otherNames': ['Electromagnetic Field Therapy'], 'description': 'Sham treatment for 4 weeks post-surgery', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22306', 'city': 'Alexandria', 'state': 'Virginia', 'country': 'United States', 'facility': 'Anderson Orthopaedic Research Institute', 'geoPoint': {'lat': 38.80484, 'lon': -77.04692}}], 'overallOfficials': [{'name': 'Gerard A. Engh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anderson Orthopaedic Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amp Orthopedics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}