Latin America Hip Fracture Mortality Study (LAMOS)

AO Clinical Investigation and Publishing Documentation

Status: Completed

Conditions: Hip Fractures

Study type: Observational

Funder types: Other

Identifiers

NCT01650064

LAMOS

Details and patient eligibility

About

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

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 60 to 110 years old

Volunteers: No Healthy Volunteers

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