Hip Fractures
Conditions
Keywords
Hip fracture, Mortality
Brief summary
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
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.
Interventions
None listed
Sponsors
AO Clinical Investigation and Publishing Documentation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death | after 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Wound healing | 30±7 days, 60±14 days, and 90± 21 days |
| Fracture healing | 60±14 days and 90± 21 days |
| Parker Mobility Score | Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) 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 |
| Harris Hip Score | Screening/Preoperative and 90 ± 21 days |
Countries
Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Uruguay
Outcome results
None listed