Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-02-04 @ 5:56 PM
Study NCT ID:
NCT02366234
Status:
WITHDRAWN
Last Update Posted:
2016-12-22
First Post:
2015-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The investigator left the institution so the study was terminated.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-20', 'studyFirstSubmitDate': '2015-02-06', 'studyFirstSubmitQcDate': '2015-02-11', 'lastUpdatePostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability with use of QuickDASH', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Overall Pain Intensity', 'timeFrame': '6 months', 'description': 'Pain Intensity measured with an 11-point ordinal measure of overall pain intensity 6 months after trauma'}, {'measure': 'Satisfaction with Treatment', 'timeFrame': '6 months', 'description': 'Satisfaction measured with an 11-point ordinal measure of satisfaction with treatment 6 months after trauma'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Distal Tubercle Fractures of the Scaphoid']}, 'descriptionModule': {'briefSummary': 'AIM:\n\nThe aim of this study is to assess whether patients with an acute distal tubercle fracture of the scaphoid treated with a removable brace for 4 to 6 weeks have the same level of symptoms and disability 6 months after injury as the average for the normal population.\n\nNULL HYPOTHESIS:\n\nPatients with an acute distal tubercle fracture of the scaphoid have Quick DASH (Disabilities of the Arm Shoulder and Hand) scores at or above the population norm (a score of 13 in Norway and 10.9 in the United States) 6 months after injury when treated symptomatically with a removable brace.', 'detailedDescription': 'Fractures of the distal scaphoid tubercle are uncommon and seem relatively benign. Not a lot is known in literature about this specific type of avulsion fracture and the treatment. Some surgeons recommend a cast for 4 to 6 weeks while others treat their patients with a removable brace. The only non-union reported in literature is Jonssen who published a case in 1990 about a non-union of a tubercle fracture in a patient with repeated trauma. Kraus et al studied 81 cases of acute scaphoid fractures and found 4 cases of tubercle avulsion fractures in this group. We suspect some patients will not seek care for this condition as it hurts for a bit and then causes no problems.\n\nResponse variables:\n\n* Quick DASH measured 6 months after injury\n* 11-point ordinal measure of overall pain intensity 6 months after trauma\n\nExplanatory variables:\n\n* Socio-demographics\n* Age, sex, ethnicity, race, marital status, education, work status\n* Questionnaires\n* Quick DASH after trauma (\\< 2 weeks)\n* 11-point ordinal measure of overall pain intensity 6 months after trauma\n* 11-point ordinal measure of satisfaction with treatment 6 months after trauma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with distal tubercle fracture of the scaphoid', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Fracture of the distal tubercle of the scaphoid on radiographs\n* Interval between injury and diagnosis of less than 2 months\n* English or Spanish fluency and literacy\n\nExclusion Criteria:\n\n* Pregnant women\n* Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness)\n* Patients with other fractures or injuries'}, 'identificationModule': {'nctId': 'NCT02366234', 'briefTitle': 'Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid', 'orgStudyIdInfo': {'id': '2014P002670'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fracture of Distal Tubercle of Scaphoid', 'description': 'Questionnaires\n\n* Quick DASH after trauma (\\< 2 weeks)\n* 11-point ordinal measure of overall pain intensity 6 months after trauma\n* 11-point ordinal measure of satisfaction with treatment 6 months after trauma'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Ring, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, {'name': 'Haaglanden Medical Centre', 'class': 'OTHER'}, {'name': 'Skane University Hospital', 'class': 'OTHER'}, {'name': 'Ghaem Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Hand and Upper Extremity Service', 'investigatorFullName': 'David C. Ring, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}