Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2026-03-03 @ 4:48 PM
Study NCT ID:
NCT05454306
Status:
SUSPENDED
Last Update Posted:
2025-02-25
First Post:
2022-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'whyStopped': 'funding', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2028-01-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-01-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-23', 'studyFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2022-07-07', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ASES Score- 2 week', 'timeFrame': '2 weeks post-operation', 'description': 'American Shoulder and Elbow Surgeons Score'}, {'measure': 'ASES Score- 6 week', 'timeFrame': '6 weeks post-operation', 'description': 'American Shoulder and Elbow Surgeons Score'}, {'measure': 'ASES Score- 3 month', 'timeFrame': '3 months post-operation', 'description': 'American Shoulder and Elbow Surgeons Score'}, {'measure': 'ASES Score- 1 year', 'timeFrame': '1 year post-operation', 'description': 'American Shoulder and Elbow Surgeons Score'}, {'measure': 'DASH Score- 2 week', 'timeFrame': '2 weeks post-operation', 'description': 'Disabilities of Arm, Shoulder and Hand Score'}, {'measure': 'DASH Score- 6 week', 'timeFrame': '6 weeks post-operation', 'description': 'Disabilities of Arm, Shoulder and Hand Score'}, {'measure': 'DASH Score- 3 month', 'timeFrame': '3 months post-operation', 'description': 'Disabilities of Arm, Shoulder and Hand Score'}, {'measure': 'DASH Score- 1 year', 'timeFrame': '1 year post-operation', 'description': 'Disabilities of Arm, Shoulder and Hand Score'}, {'measure': 'Radiographic union rate', 'timeFrame': '1 year post-operation', 'description': 'Radiographic union is defined as a 2/3rd circumferential cortical bridging between medial and lateral fragments on both radiographs as determined by the treating surgeon and an independent radiologist'}, {'measure': 'Clinical union rate', 'timeFrame': '1 year post-operation', 'description': 'Clinical union is defined as the absence of pain over the fracture site upon palpation.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Clavicle fracture', 'Clavicle pin'], 'conditions': ['Clavicle Fracture']}, 'descriptionModule': {'briefSummary': 'The goals of this multi-site study are to evaluate the union rate, patient satisfaction, and functional results of the Section 510(K) approved Anser Clavicle Pin in a prospective 50 patient clinical trial in a U.S. population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Displaced midshaft clavicle fracture Type 2B according to the Robinson Classification\n* Skeletally mature\n* Surgery performed within 4 weeks after trauma\n\nExclusion Criteria:\n\n* Not fit for surgery by the anesthesiologist\n* Nonunion or previous malunion\n* Possible noncompliant patients (eg, alcohol and drug addiction, dementia)\n* Additional neurovascular injury\n* Pathologic fractures'}, 'identificationModule': {'nctId': 'NCT05454306', 'briefTitle': 'Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'The Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures; A U.S. Prospective Case Series', 'orgStudyIdInfo': {'id': 'ORSU-2022-31047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anser Clavicle Pin', 'description': 'Patients treated with Anser Clavicle Pin in the setting of a displaced midshaft clavicle fracture', 'interventionNames': ['Device: Anser Clavicle Pin']}], 'interventions': [{'name': 'Anser Clavicle Pin', 'type': 'DEVICE', 'description': 'The Anser Clavicle Pin is an intramedullary device that has been studied in 20 patients in an EU-based prospective case series.28 A 100% union rate was found. The Constant-Murley score at 1-year was 96.7 (SD 5). The Disabilities of Arm, Shoulder and Hand score was 5.1 (SD 10). There were no infections, neuropathy of the supraclavicular nerve or hardware irritation requiring removal of hardware. Three device-related complications (15%) occurred including plastic deformation, protrusion and hardware failure. VAS satisfaction was 8.9 (SD 1) at the 1-year follow up.', 'armGroupLabels': ['Anser Clavicle Pin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Jonathan Braman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}