Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT07147504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship Between Mortality Rates of Fractures in Different Sites and Several Factors in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016103', 'term': 'Spinal Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-23', 'size': 128048, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-22T14:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'From enrollment to the end of data collection at 4 months'}, {'measure': 'Fracture-related mortality', 'timeFrame': 'From enrollment to the end of data collection at 4 months'}], 'secondaryOutcomes': [{'measure': 'Postoperative complication rate', 'timeFrame': 'From enrollment to the end of data collection at 4 months'}, {'measure': 'Recurrent fracture rate', 'timeFrame': 'From enrollment to the end of data collection at 4 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fracture', 'Limb fractures', 'Spinal fractures', 'Elderly people', 'the old', 'Survival rate'], 'conditions': ['Fracture Lower Leg', 'Fracture Dislocation of Upper Limb Joint', 'Spinal Fractures']}, 'referencesModule': {'references': [{'pmid': '30811581', 'type': 'RESULT', 'citation': 'Sine K, Lee Y, Zullo AR, Daiello LA, Zhang T, Berry SD. Incidence of Lower-Extremity Fractures in US Nursing Homes. J Am Geriatr Soc. 2019 Jun;67(6):1253-1257. doi: 10.1111/jgs.15825. Epub 2019 Feb 27.'}, {'pmid': '27578967', 'type': 'RESULT', 'citation': 'Oertel MJ, Graves L, Al-Hihi E, Leonardo V, Hopkins C, DeSouza K, Bhattacharya RK. Osteoporosis management in older patients who experienced a fracture. Clin Interv Aging. 2016 Aug 22;11:1111-6. doi: 10.2147/CIA.S107720. eCollection 2016.'}, {'pmid': '32302028', 'type': 'RESULT', 'citation': 'Berry SD, Daiello LA, Lee Y, Zullo AR, Wright NC, Curtis JR, Kiel DP. Secular Trends in the Incidence of Hip Fracture Among Nursing Home Residents. J Bone Miner Res. 2020 Sep;35(9):1668-1675. doi: 10.1002/jbmr.4032. Epub 2020 May 8.'}, {'pmid': '39476530', 'type': 'RESULT', 'citation': 'Berner JE, Ortiz-Llorens M, Fries CA, Nanchahal J, Jain A; QUINTET Collaborative. Quality of Life after Open Extremity Trauma (QUINTET) study: An international, multicentric, observational, cohort study of quality of life following lower extremity open fractures. J Plast Reconstr Aesthet Surg. 2024 Dec;99:486-493. doi: 10.1016/j.bjps.2024.10.025. Epub 2024 Oct 16.'}, {'pmid': '27093957', 'type': 'RESULT', 'citation': 'Tarride JE, Burke N, Leslie WD, Morin SN, Adachi JD, Papaioannou A, Bessette L, Brown JP, Pericleous L, Muratov S, Hopkins RB. Loss of health related quality of life following low-trauma fractures in the elderly. BMC Geriatr. 2016 Apr 19;16:84. doi: 10.1186/s12877-016-0259-5.'}, {'pmid': '40056731', 'type': 'RESULT', 'citation': 'Larsen P, Elsoe R. Long-term effect of lower limb fractures A national register-based cohort study with a mean of 16.7 years follow-up. Injury. 2025 Apr;56(4):112239. doi: 10.1016/j.injury.2025.112239. Epub 2025 Mar 4.'}]}, 'descriptionModule': {'briefSummary': "Background and Purpose:\n\nAs people age, bones become weaker and break more easily. Older adults (people 60 years and older) who break bones may face serious health problems and have a higher chance of dying compared to younger people. The location of the broken bone, a person's age, and overall health may affect the chances of survival.\n\nThis study will conduct a retrospective analysis of medical records from geriatric patients who underwent surgical intervention for bone fractures at Shanghai Sixth People's Hospital between 2010 and 2019. The primary objective is to identify the key prognostic factors associated with post-operative mortality in this patient cohort.\n\nThe study will retrospectively analyze the medical records of patients who meet all of the following criteria:\n\nAged 60 years or older at the time of fracture diagnosis. Residents of Shanghai. Diagnosed with a fracture of the extremities (upper or lower limbs) or the spine.\n\nUnderwent surgical intervention for the diagnosed fracture.\n\nThe investigators will assess the following variables as potential prognostic factors for post-operative mortality:\n\nFracture Characteristics: The anatomical location of the fracture (e.g., hip, spine, upper extremity, lower extremity).\n\nPatient Demographics: The patient's age at the time of injury. Physiological Status: Indicators of the patient's nutritional and metabolic health.\n\nComorbidities: The presence and severity of pre-existing medical conditions.\n\nHow investigators will do this study:\n\nThis study is designed as a retrospective cohort analysis. Data will be systematically extracted from existing patient medical records. As an observational study, it involves no new interventions or modifications to patient care. The primary endpoint is all-cause mortality, which will be assessed at 1, 3, and 5 years post-operatively to determine long-term survival rates.\n\nInvestigators will group participants by:\n\nThe location of fracture (20 different bone locations); Age (60-65, 66-70, 71-75, 76-80, and over 80 years old); Nutrition and health status.\n\nWhy This Study Matters:\n\nThe results of this study will help doctors better understand which older patients are at higher risk after breaking a bone. This information could help healthcare teams provide better care and potentially save lives by identifying patients who need extra attention and treatment.\n\nStudy Details:\n\nThis study will examine records from approximately 2000 participants; All participants already received their treatment between 2010-2019; No new treatments or procedures will be performed; Participant's privacy will be completely protected; The study will take about 14 months to complete;\n\nThis research will help improve care for older adults who experience bone fractures and may guide treatment decisions for future patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly patients aged 60 years and older who underwent surgical treatment for fractures', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients admitted to the National Orthopedic Center of Shanghai Sixth People's Hospital between January 1, 2010, and December 31, 2019;\n* Age ≥ 60 years;\n* Shanghai resident registration;\n* Diagnosed with limb or spinal fractures and receiving surgical treatment at Shanghai Sixth People's Hospital.\n\nExclusion Criteria:\n\n* Multiple fractures;\n* Conservative treatment selected;\n* Incomplete medical records."}, 'identificationModule': {'nctId': 'NCT07147504', 'briefTitle': 'Relationship Between Mortality Rates of Fractures in Different Sites and Several Factors in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 6th People's Hospital"}, 'officialTitle': 'A Retrospective Study on the Relationship Between Mortality Rates of Fractures in Different Sites and Factors Such as Age, Metabolism, and Nutritional Status in Elderly Patients: A Single-center Retrospective Study', 'orgStudyIdInfo': {'id': '2025-KY-231(K)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Upper limb fractures Group'}, {'label': 'Lower limb fracture Group'}, {'label': 'Spinal fractures Group'}, {'label': '60-64 years old Group'}, {'label': '65-69 years old Group'}, {'label': '70-74 years old Group'}, {'label': '75-79 years old Group'}, {'label': '80 years and above Group'}, {'label': 'Normal nutritional status Group'}, {'label': 'Malnutrition status Group'}, {'label': 'Overnutrition status Group'}, {'label': 'Normal metabolism Group'}, {'label': 'Abnormal metabolism group'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jiachen Wu', 'role': 'CONTACT', 'email': 'dqsj7010@163.com', 'phone': '+86 15250601676'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "This study uses medical data involving patients' personal information, and making it public may violate patients' privacy."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 6th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate chief physician', 'investigatorFullName': 'Chaoyin Jiang', 'investigatorAffiliation': "Shanghai 6th People's Hospital"}}}}