Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT01278251
Status:
COMPLETED
Last Update Posted:
2011-01-17
First Post:
2011-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Functional Review of Distal Biceps Re-Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'lastUpdateSubmitDate': '2011-01-14', 'studyFirstSubmitDate': '2011-01-14', 'studyFirstSubmitQcDate': '2011-01-14', 'lastUpdatePostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Distal Biceps Ruptures']}, 'descriptionModule': {'briefSummary': 'This study seeks to test the hypothesis that endobutton repair of the ruptured distal biceps successfully restores elbow function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have received primary distal biceps repair by Dr. Schmidt.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary distal biceps repair with endobutton\n* at least two years from date of surgery\n\nExclusion Criteria:\n\n* any ipsilateral wrist, forearm, or elbow condition\n* any contraindication to having an MRI'}, 'identificationModule': {'nctId': 'NCT01278251', 'briefTitle': 'Functional Review of Distal Biceps Re-Insertion', 'organization': {'class': 'OTHER', 'fullName': 'West Penn Allegheny Health System'}, 'orgStudyIdInfo': {'id': 'RC-4556'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endobutton', 'interventionNames': ['Procedure: Distal Biceps Re-Insertion']}], 'interventions': [{'name': 'Distal Biceps Re-Insertion', 'type': 'PROCEDURE', 'armGroupLabels': ['Endobutton']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15237', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny Imaging of McCandless', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Penn Allegheny Health System', 'class': 'OTHER'}, 'responsibleParty': {'oldOrganization': 'Allegheny General Hospital'}}}}