Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-01-06 @ 1:48 PM
Study NCT ID:
NCT00595634
Status:
TERMINATED
Last Update Posted:
2014-04-01
First Post:
2008-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INTUIT Hip Fracture Outcome Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'whyStopped': 'Could not power primary endpoint due to lost to follow-up rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-31', 'studyFirstSubmitDate': '2008-01-04', 'studyFirstSubmitQcDate': '2008-01-04', 'lastUpdatePostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mobility function as defined by the Timed Up & Go (TUG) frequency.', 'timeFrame': 'Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months'}], 'secondaryOutcomes': [{'measure': 'Lower Extremity Activity Scale', 'timeFrame': 'Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months'}, {'measure': 'EuroQol', 'timeFrame': 'Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months'}, {'measure': 'Visual Analogue Score (VAS)', 'timeFrame': 'Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months'}, {'measure': 'Adverse Event', 'timeFrame': 'When necessary'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hip', 'Fracture', 'Intertrochanteric', 'intramedullary'], 'conditions': ['Unstable Intertrochanteric Hip Fractures']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.tria.com/', 'label': 'TRIA Orthopaedic Center'}]}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to characterize patients' course of recovery in the year following the initial surgery for unstable intertrochanteric hip fractures treated with the InterTAN intramedullary hip screw device. This will be done by collecting patient outcome measures of health related quality of life and functional status including return to normal gait. Secondary objectives are to document any adverse events associated with the procedure, and to analyze differences in recovery due to differences in age, gender, co-morbidities, nutrition, residence and ambulation status, and use of mobility aids."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting with unilateral unstable intertrochanteric hip fracture (as defined by Hennepin County Medical Center intertrochanteric hip fracture classification system, Kyle et al, 1979) without other lower extremity fractures.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral unstable intertrochanteric hip fracture without other lower extremity fractures.\n* Community and household ambulators with or without assistive devices.\n* Age 50 years or greater.\n\nExclusion Criteria:\n\n* Stable intertrochanteric hip fracture.\n* Bilateral or two or more lower extremity fractures.\n* Non-functional ambulators or non-ambulators.\n* Age less than 50 years.'}, 'identificationModule': {'nctId': 'NCT00595634', 'acronym': 'INTUIT', 'briefTitle': 'INTUIT Hip Fracture Outcome Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'Intramedullary Nailing for Treatment of Unstable InterTrochanteric (INTUIT) Hip Fracture Outcome Study.', 'orgStudyIdInfo': {'id': '03618-07-A'}}, 'contactsLocationsModule': {'locations': [{'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sonoran Orthopaedic Trauma Surgeons, PLLC', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Shrock Orthopedic Research, LLC', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Orthopaedic Center of Vero Beach', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '55426', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Park Nicollet', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}], 'overallOfficials': [{'name': 'Gregory Brown, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TRIA Orthopaedic Center, Park Nicollet Health Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}