Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 7:42 AM
Study NCT ID:
NCT07286357
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-Center Retrospective Data Collection Protocol to Evaluate the Real World Usage of the Orthofix AccelStim Device to Treat Fresh Metatarsal Fractures
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': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-12-03', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing Status', 'timeFrame': '3, 6, and 12 month', 'description': 'Quantitative and qualitative assessments of clinical and radiographic healing (as available per standard of care)'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Baseline, 3, 6, and 12 month', 'description': 'Numerical Pain Rating Scale (NPRS)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Metatarsal Fracture']}, 'descriptionModule': {'briefSummary': 'This study examines the effect of using the AccelStim bone growth stimulator on subjects undergoing treatment for fresh metatarsal fractures.', 'detailedDescription': 'The objective of this investigation is to study the effect of using LIPUS treatment (via AccelStim) in subjects with fresh metatarsal fractures. The sponsor hypothesizes that use of AccelStim 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': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who were treated for eligible fresh metatarsal fractures and were subsequently prescribed an Orthofix AccelStim device will be considered for participation in this retrospective study. Cases will be identified by searching local medical records and/or device prescription information received at Orthofix.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fresh metatarsal fracture patient that has been prescribed an Orthofix AccelStim device\n* Patient is 18 years or older at the time of treatment\n\nExclusion Criteria:\n\n-Patient is a prisoner'}, 'identificationModule': {'nctId': 'NCT07286357', 'acronym': 'ASRW', 'briefTitle': 'A Multi-Center Retrospective Data Collection Protocol to Evaluate the Real World Usage of the Orthofix AccelStim Device to Treat Fresh Metatarsal Fractures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orthofix Inc.'}, 'officialTitle': 'A Multi-Center Retrospective Data Collection Protocol to Evaluate the Real World Usage', 'orgStudyIdInfo': {'id': 'CIP-ASRW-24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AccelStim (LIPUS)', 'description': 'This group will include subjects where AccelStimStim (LIPUS) is used to treat fresh metatarsal fracture', 'interventionNames': ['Device: AccelStim (LIPUS)']}, {'label': 'Control (no LIPUS device)', 'description': 'This group will include subjects where AccelStimStim (LIPUS) was not used to treat fresh metatarsal fracture'}], 'interventions': [{'name': 'AccelStim (LIPUS)', 'type': 'DEVICE', 'otherNames': ['Low Intensity Pulsed UltraSound'], 'description': 'Subjects treated with LIPUS were directed to use the AccelStim device for 20 minutes per day, up to 6 months or until no longer needed.', 'armGroupLabels': ['AccelStim (LIPUS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60208', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '60056', 'city': 'Mount Prospect', 'state': 'Illinois', 'country': 'United States', 'facility': 'Endeavor Health', 'geoPoint': {'lat': 42.06642, 'lon': -87.93729}}, {'zip': '20707', 'city': 'Laurel', 'state': 'Maryland', 'country': 'United States', 'facility': 'Precision Orthopedics', 'geoPoint': {'lat': 39.09928, 'lon': -76.84831}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orthofix Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}