Overview

This trial is active, not recruiting.

Condition hip fractures
Sponsor AO Clinical Investigation and Documentation
Start date January 2013
End date April 2016
Trial size 200 participants
Trial identifier NCT01650064, LAMOS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Death
time frame: after 1 year

Secondary Outcomes

Measure
Harris Hip Score
time frame: Screening/Preoperative and 90 ± 21 days
Parker Mobility Score
time frame: Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) days
Wound healing
time frame: 30±7 days, 60±14 days, and 90± 21 days
Fracture healing
time frame: 60±14 days and 90± 21 days
Anticipated surgical treatment-related adverse events
time frame: 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
time frame: Screening/Preoperative, 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Latin America Hip Fracture Mortality Study
Principal investigator Wiliam Belangero, Dr.med
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by AO Clinical Investigation and Documentation.