Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-22 @ 7:11 PM
Study NCT ID:
NCT01975467
Status:
TERMINATED
Last Update Posted:
2016-12-28
First Post:
2013-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005594', 'term': 'Fracture Fixation, Intramedullary'}], 'ancestors': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}, {'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'repstein@sonomaorthopedics.com', 'phone': '8479872516', 'title': 'Rick Epstein', 'organization': 'Sonoma Orthopedics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Group - Nonoperative', 'description': 'Subjects that were treated with a sling for their displaced midshaft clavicle fracture.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Test Group - Intramedullary Nail', 'description': 'Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.\n\nCRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'DASH Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group - Nonoperative', 'description': 'Subjects that were treated with a sling for their displaced midshaft clavicle fracture.'}, {'id': 'OG001', 'title': 'Test Group - Intramedullary Nail', 'description': 'Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.\n\nCRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.'}], 'timeFrame': 'One time point', 'description': 'Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.', 'reportingStatus': 'POSTED', 'populationDescription': 'Terminated due to low enrollment'}, {'type': 'SECONDARY', 'title': 'Range of Motion and Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group - Nonoperative', 'description': 'Subjects that were treated with a sling for their displaced midshaft clavicle fracture.'}, {'id': 'OG001', 'title': 'Test Group - Intramedullary Nail', 'description': 'Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.\n\nCRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.'}], 'timeFrame': 'One time point', 'description': 'The ASES instrument will be used to assess range of motion and strength.', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group - Nonoperative', 'description': 'Subjects that were treated with a sling for their displaced midshaft clavicle fracture.'}, {'id': 'FG001', 'title': 'Test Group - Intramedullary Nail', 'description': 'Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.\n\nCRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Study terminated before enrollment', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Study terminated before enrollment', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group - Nonoperative', 'description': 'Subjects that were treated with a sling for their displaced midshaft clavicle fracture.'}, {'id': 'BG001', 'title': 'Test Group - Intramedullary Nail', 'description': 'Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.\n\nCRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}]}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Low Enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2013-10-23', 'resultsFirstSubmitDate': '2016-11-01', 'studyFirstSubmitQcDate': '2013-10-28', 'lastUpdatePostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-01', 'studyFirstPostDateStruct': {'date': '2013-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DASH Score', 'timeFrame': 'One time point', 'description': 'Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.'}], 'secondaryOutcomes': [{'measure': 'Range of Motion and Strength', 'timeFrame': 'One time point', 'description': 'The ASES instrument will be used to assess range of motion and strength.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['midshaft clavicle fracture', 'intramedullary nail', 'sling'], 'conditions': ['Fracture of Clavicle']}, 'descriptionModule': {'briefSummary': 'The objective of this post-market clinical study is to compare one to three year post treatment results, range of motion, strength, patient related functional outcomes and patient satisfaction, of internal fixation using the Sonoma Orthopedic Products CRx™ as compared to nonoperative management (e.g. sling) of similar displaced midshaft clavicle fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population is open to anyone over the age of 18 that meet the study eligibility criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A displaced transverse or oblique midshaft clavicle fracture with or without comminution\n* Must be 12 ± 2 months to 36 ± 2 months post-treatment\n* Must have received nonoperative treatment or operative treatment with a CRx™ device, no other devices, for their clavicle fracture\n* Male or female at least 18 years of age\n* Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol\n* Ability to understand and provide written authorization for use and disclosure of personal health information\n\nExclusion Criteria:\n\n* Open, or segmental clavicle fracture\n* Any clavicle or upper extremity fracture previous, concurrent, or subsequent to the study fracture\n* Removal of the CRx™ device within 8 weeks of the study visit\n* History of alcoholism\n* Currently on chemotherapy or radiation therapy\n* Habitual use of narcotic pain medications prior to injury or after injury for reasons other than clavicle pain\n* Currently on worker's compensation\n* History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis\n* Rheumatoid arthritis or other inflammatory arthropathies.\n* History of chronic pain issues for reasons other than clavicle pain or psychiatric disorder that precludes reliable follow-up.\n* Women that are pregnant or think that they might be pregnant"}, 'identificationModule': {'nctId': 'NCT01975467', 'briefTitle': 'Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonoma Orthopedic Products, Inc.'}, 'officialTitle': 'CLAVICLE FRACTURE OUTCOMES: 1-3 YEAR FOLLOW UP OF DISPLACED MIDSHAFT FRACTURES TREATED WITH INTRAMEDULARY NAIL vs. NONOPERATIVE TREATMENT', 'orgStudyIdInfo': {'id': 'CRx-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group - Nonoperative', 'description': 'Subjects that were treated with a sling for their displaced midshaft clavicle fracture.'}, {'label': 'Test Group - Intramedullary Nail', 'description': 'Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.', 'interventionNames': ['Device: CRx']}], 'interventions': [{'name': 'CRx', 'type': 'DEVICE', 'otherNames': ['Intramedullary Nail'], 'description': 'The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.', 'armGroupLabels': ['Test Group - Intramedullary Nail']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95521', 'city': 'Arcata', 'state': 'California', 'country': 'United States', 'facility': 'North Coast Orthopaedics and Sports Medicine', 'geoPoint': {'lat': 40.86652, 'lon': -124.08284}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Madison Center/Polyclinic', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'John LeBlanc, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Coast Orthopaedics and Sports Medicine'}, {'name': 'Carl Basamania, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Madison Center/Polyclinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonoma Orthopedic Products, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}