Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-04-21 @ 10:51 PM
Study NCT ID:
NCT02279550
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2014-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Institutional Registry of Hip Fracture in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-17', 'size': 99013, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-17T19:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2014-10-16', 'studyFirstSubmitQcDate': '2014-10-29', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'frailty (measured by the Rockwood Scale)', 'timeFrame': '1 year', 'description': 'It will performed once included in the Register the Rockwood Scale of Frailty and year follow-up after.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hip fracture, elderly'], 'conditions': ['Hip Fracture']}, 'referencesModule': {'references': [{'pmid': '9096540', 'type': 'BACKGROUND', 'citation': 'Wolinsky FD, Fitzgerald JF, Stump TE. The effect of hip fracture on mortality, hospitalization, and functional status: a prospective study. Am J Public Health. 1997 Mar;87(3):398-403. doi: 10.2105/ajph.87.3.398.'}, {'pmid': '11386929', 'type': 'BACKGROUND', 'citation': 'Hannan EL, Magaziner J, Wang JJ, Eastwood EA, Silberzweig SB, Gilbert M, Morrison RS, McLaughlin MA, Orosz GM, Siu AL. Mortality and locomotion 6 months after hospitalization for hip fracture: risk factors and risk-adjusted hospital outcomes. JAMA. 2001 Jun 6;285(21):2736-42. doi: 10.1001/jama.285.21.2736.'}, {'pmid': '14974897', 'type': 'BACKGROUND', 'citation': 'Alarcon Alarcon T, Gonzalez-Montalvo JI. [Osteoporotic hip fracture. Predictive factors of short-and long-term functional recovery]. An Med Interna. 2004 Feb;21(2):87-96. doi: 10.4321/s0212-71992004000200010. No abstract available. Spanish.'}, {'pmid': '19730176', 'type': 'BACKGROUND', 'citation': 'Robinson TN, Eiseman B, Wallace JI, Church SD, McFann KK, Pfister SM, Sharp TJ, Moss M. Redefining geriatric preoperative assessment using frailty, disability and co-morbidity. Ann Surg. 2009 Sep;250(3):449-55. doi: 10.1097/SLA.0b013e3181b45598.'}, {'pmid': '19287895', 'type': 'BACKGROUND', 'citation': 'Riera-Espinoza G. Epidemiology of osteoporosis in Latin America 2008. Salud Publica Mex. 2009;51 Suppl 1:S52-5. doi: 10.1590/s0036-36342009000700009.'}, {'pmid': '27551569', 'type': 'DERIVED', 'citation': 'Benchimol J, Fiorentini F, Elizondo CM, Boietti BR, Carabelli G, Barla J, Sancineto C, Waisman GD, Giunta DH. Institutional Registry of Elderly Patients With Hip Fracture in a Community-Based Tertiary Care Hospital in Argentina (RIAFC). Geriatr Orthop Surg Rehabil. 2016 Sep;7(3):121-5. doi: 10.1177/2151458516651309. Epub 2016 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to create an institutional and population-based registry of Hip fracture in the elderly with a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.', 'detailedDescription': 'All patients over 65 years old who are admitted to the orthopedic and traumatology ward diagnosed with hip fracture will be assessed.\n\nThe generation of the list of potentially evaluable patients will be performed daily.\n\nOnce defined patient inclusion, an intern take oral informed consent and will proceed to complete the CRF.\n\nCohort will be followed at 3 months and a second follow-up at year.\n\nVariables to be measured:\n\nPatient Data Comorbidities Charlson score Scales functionality Factors prior to the fall Medications Trauma variables Complications Mortality'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'aged \\>65 hip fracture', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients over 65 with hip fracture.\n2. Admission to HIBA\n3. Followed by any health care provider. -\n\nExclusion Criteria:\n\n1 Patient refuses to participate in the registration or informed consent process\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02279550', 'briefTitle': 'Institutional Registry of Hip Fracture in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Italiano de Buenos Aires'}, 'officialTitle': 'Institutional Registry of Hip Fracture in the Elderly', 'orgStudyIdInfo': {'id': '1950'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hip fracture', 'description': 'aged \\>65 with hip fracture'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1199', 'city': 'Ciudad Autonoma de Buenos Aires', 'state': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Diego H Giunta, MD', 'role': 'CONTACT', 'email': 'diego.giunta@hospitalitaliano.org.ar', 'phone': '54119590200', 'phoneExt': '4419'}], 'facility': 'Hospital Italiano de Buenos Aires'}], 'centralContacts': [{'name': 'Diego H Giunta, MD', 'role': 'CONTACT', 'email': 'diego.giunta@hospitalitaliano.org.ar', 'phone': '5411-9590200', 'phoneExt': '4419'}, {'name': 'Javier A Benchimol, MD', 'role': 'CONTACT', 'email': 'javier.benchimol@hospitalitaliano.org.ar'}], 'overallOfficials': [{'name': 'Javier A Benchimol, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Italiano de Buenos Aires'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Italiano de Buenos Aires', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Javier Alberto Benchimol', 'investigatorAffiliation': 'Hospital Italiano de Buenos Aires'}}}}