Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT07282067
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Orthofix PhysioStim PEMF Ankle Fusion Retrospective
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical healing', 'timeFrame': 'Multiple, up to 12 months', 'description': 'Clinical healing, as defined per standard of care, as available'}, {'measure': 'Secondary surgeries', 'timeFrame': 'For the period 12 months following the start of treatment', 'description': 'Rate of secondary surgeries (# subjects requiring additional surgeries / # eligible subjects)'}, {'measure': 'Safety endpoints', 'timeFrame': 'For the period 12 months following the start of treatment', 'description': 'Incidence of device and procedure-related Adverse Events (AEs) and Serious Adverse Events (SAEs) through 12 months post-treatment.'}, {'measure': 'Pain (NPRS)', 'timeFrame': 'Multiple, up to 12 months', 'description': 'Pain reduction using Numerical Pain Rating Scale (NPRS) will be reported at multiple time points, as available'}], 'primaryOutcomes': [{'measure': 'Radiographic fusion rate at 6 months post treatment', 'timeFrame': '6 months from the start of treatment', 'description': 'Fusion rate (# subjects fused / # total evaluable subjects) based on radiographic assessment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ankle', 'tibiotalar', 'PEMF', 'hindfoot', 'pulsed electromagnetic fields', 'Orthofix'], 'conditions': ['Ankle Fusion', 'Hindfoot Arthrodesis', 'Ankle Arthrodesis', 'Tibiotalar Arthrodesis']}, 'descriptionModule': {'briefSummary': 'This study examines the effect of using the PhysioStim bone growth stimulator on subjects undergoing treatment for ankle and hindfoot fusion surgery.', 'detailedDescription': 'The objective of this investigation is to study the effect of using adjunctive PEMF treatment (via PhysioStim) in subjects undergoing ankle fusion, and also as nonoperative treatment for failed ankle fusion. The sponsor hypothesizes that use of PhysioStim will result in higher rates of fusion compared to that of control. In addition to analyzing the primary endpoint, the study will collect safety information to confirm the favorable safety profile established in prior device usage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '23 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target population will be males and females who underwent an ankle fusion procedure and were at least 23 years of age at the time of surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Condition requiring ankle fusion surgery or nonoperative treatment for failed ankle fusion\n* Age 23 years or older\n* Subjects must have a minimum of 6 months follow-up data or evidence of fusion, whichever occurs first\n\nExclusion Criteria:\n\n* Subject is a prisoner'}, 'identificationModule': {'nctId': 'NCT07282067', 'acronym': 'PSAF', 'briefTitle': 'Orthofix PhysioStim PEMF Ankle Fusion Retrospective', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orthofix Inc.'}, 'officialTitle': 'A Retrospective Study to Assess the Efficacy of PEMF Treatment in Ankle Fusion', 'orgStudyIdInfo': {'id': 'CIP-PSAF-24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PEMF use adjunct to ankle/hindfoot fusion', 'description': 'This group will include subjects where PhysioStim (PEMF) is used adjunctively to an ankle/hindfoot fusion procedure.', 'interventionNames': ['Device: Pulsed electromagnetic field (PEMF) stimulation']}, {'label': 'PEMF use for failed ankle/hindfoot fusion', 'description': 'This group will include subjects where PhysioStim (PEMF) is used to treat a failed ankle/hindfoot fusion procedure.', 'interventionNames': ['Device: Pulsed electromagnetic field (PEMF) stimulation']}, {'label': 'Ankle/hindfoot fusion, no device (Control)', 'description': 'This group will include subjects where PhysioStim (PEMF) is NOT used adjunctively to an ankle/hindfoot fusion procedure. Subjects will be identified as those indicated to receive PEMF, but did not due to reasons such as insurance denial, patient declined to use the device, etc.', 'interventionNames': ['Other: Control']}, {'label': 'Failed ankle/hindfoot fusion, no device (Control)', 'description': 'This group will include subjects where PhysioStim (PEMF) is NOT used to treat a failed ankle/hindfoot fusion procedure. Subjects will be identified as those indicated to receive PEMF, but did not due to reasons such as insurance denial, patient declined to use the device, etc.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Pulsed electromagnetic field (PEMF) stimulation', 'type': 'DEVICE', 'description': 'Subjects treated with PEMF with be directed to use the device for 3 hours per day, up to 6 months or until no longer needed.', 'armGroupLabels': ['PEMF use adjunct to ankle/hindfoot fusion', 'PEMF use for failed ankle/hindfoot fusion']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Control (no PEMF)', 'armGroupLabels': ['Ankle/hindfoot fusion, no device (Control)', 'Failed ankle/hindfoot fusion, no device (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85028', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Foot Health', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Foot and Ankle Institute', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'OrthoArizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '93449', 'city': 'Pismo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Byron COllier DPM, Inc', 'geoPoint': {'lat': 35.14275, 'lon': -120.64128}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'East Village Foot and Ankle', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '20707', 'city': 'Laurel', 'state': 'Maryland', 'country': 'United States', 'facility': 'Precision Orthopedics and Sports Medicine', 'geoPoint': {'lat': 39.09928, 'lon': -76.84831}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina Research Institute, Inc', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Lone Star Orthopaedic and Spine Specialists', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orthofix Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}