NCT01650064

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
7 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 13, 2020

Status Verified

January 1, 2017

Enrollment Period

3.2 years

First QC Date

July 6, 2012

Last Update Submit

August 11, 2020

Conditions

Hip Fractures

Keywords

Hip fractureMortality

Outcome Measures

Primary Outcomes (1)

  • Death

    after 1 year

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Eligibility Criteria

Age60 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with surgically-treated hip fracture in Latin America

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

Hospital Vila Velha

Espírito Santo, Brazil

Location

IOT - Instituto de Ortopedia de Traumatologia de Passo Fundo

Passo Fundo, Brazil

Location

Hospital Municipal Miguel Couto

Rio de Janeiro, Brazil

Location

Hospital das Clinicas da UNICAMP

São Paulo, Brazil

Location

Hospital Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, Brazil

Location

Hospital São Paulo

São Paulo, Brazil

Location

Universidad de São Paulo

São Paulo, Brazil

Location

Hospital Clínico Pontificia Universidad Católica de Chile

Santiago, Chile

Location

Hospital del Trabajador de Santiago

Santiago, Chile

Location

Hospital Infantil de San José

Bogotá, Colombia

Location

Hospital San Vicente de Paúl

San José, Costa Rica

Location

Hospital Teodoro Maldonado Carbo

Guayaquil, Ecuador

Location

Hospital de Traumatología y Ortopedia "Lomas Verdes"

Mexico City, Mexico

Location

Hospital de Traumatología y Ortopedia UMAE #21

Monterrey, Mexico

Location

Asociación Española Primera de Socorros Mutuos

Montevideo, Uruguay

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Wiliam Belangero, Dr.med

    Department of Orthopaedics and Traumatology, Hospital das Clinicas da UNICAMP, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2012

First Posted

July 26, 2012

Study Start

January 1, 2013

Primary Completion

April 1, 2016

Study Completion

December 1, 2016

Last Updated

August 13, 2020

Record last verified: 2017-01

Locations

ME(2)UR(1)AR(1)CO(1)EC(1)BR(7)CL(2)