Latin America Hip Fracture Mortality Study

Study Overview
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Brief Summary
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The purpose of this study is to estimate the survival proportion one year after surgery for intertrochanteric fracture in older adults in Latin America.

Detailed Description
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This is a multi-center, prospective, observational clinical study to evaluate mortality in patients with surgically-treated hip fracture in Latin America, and investigate associated prognostic factors. Patients will be followed for 12 months.

Official Title
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Latin America Hip Fracture Mortality Study

Conditions
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Hip Fractures

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 60 years and older Diagnosis of an isolated intertrochanteric fracture (AO 31-A) confirmed by radiographic evaluation Primary surgical fracture treatment within 10 days after trauma No prior treatment for the fracture Ability to understand the content of the patient information / informed consent form Willingness and ability to participate in the clinical investigation according to the CIP Signed and dated IRB/EC-approved written informed consent Exclusion Criteria: Polytrauma (ie, multiple injuries, whereof one or the combination of several injuries is life threatening) Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis) Active malignancy Class 5 and 6 of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 2) Neurological and/or psychiatric disorders that would preclude reliable assessment (eg, Parkinson's disease, multiple sclerosis, severe depression) Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment Prisoner Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study Noncompletion of patient baseline questionnaires Prior implant on the fractured hip

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | after 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score |  | Screening/Preoperative and 90 ± 21 days | 
| Parker Mobility Score |  | Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) days | 
| Wound healing |  | 30±7 days, 60±14 days, and 90± 21 days | 
| Fracture healing |  | 60±14 days and 90± 21 days | 
| Anticipated surgical treatment-related adverse events |  | Postoperative (2 to 5 days), 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days | 
| EQ-5D |  | Screening/Preoperative, 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip fracture, Mortality