NCT04217642

Brief Summary

This research project is an observational, analytical, prospective cohort study, which aims to identify and describe the causes of delay in surgical intervention in patients with a diagnosis of hip fracture at Hospital Universitario San José, correlate those factors with complications , the impact of the quality of life and the main outcomes in relation to morbidity and mortality associated with the delay in surgery in the study population. In order to carry out this investigation, the recruitment of patients over 18 years old, who enter our institution with a diagnosis of hip fracture, prior acceptance by the patient or his family member to participate through an informed consent signature is carried out. Subsequently, the research team consults the medical history to monitor the factors that influence the time from admission to surgery. A survey is also conducted to assess the quality of life and how your health status can affect it; which is performed during the hospital stay before surgery, the third day after surgery, one month and 6 months later, the last two surveys are conducted in the control consultation with the treatment team or by call telephone. It is clear that this study does not represent any risk for the participants, the information collected will be confidential and will not be used for any other purpose outside the investigation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

January 1, 2020

Last Update Submit

January 15, 2021

Conditions

Hip Fractures

Keywords

Hip fracturesDelay surgeryQuality of lifeOutcomes

Outcome Measures

Primary Outcomes (1)

  • Delay surgery

    Time, in hours, from emergency room admission until surgery.

    1 month

Secondary Outcomes (2)

  • QoL

    12 months

  • Mortality

    12 months

Study Arms (1)

Delay surgery

Patients who have passed more than 48 hours from admission to surgery

Procedure: Osteosynthesis

Interventions

OsteosynthesisPROCEDURE

The specific surgical technique -osteosynthesis, hemiarthroplasty, or total hip arthroplasty- will depend on the characteristics of the proximal femur fracture in each patient.

Also known as: Hemiarthroplasty, Total hip arthroplasty
Delay surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients hospitalized at the San José de Popayán University Hospital for surgical correction of hip fractures that meet the inclusion criteria since 2019. Written informed consent will be obtained from all patients.

You may qualify if:

  • Adults (male or female) ≥ 18 years of age
  • Diagnosis of femoral fracture
  • Receiving surgical treatment

You may not qualify if:

  • Patients with cognitive disorders that prevent interrogation and assessment of quality of life.
  • Patients referred to another institution for surgery.
  • Patient who decides to voluntarily withdraw from the investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario San José

Popayán, Cauca Department, 19001, Colombia

RECRUITING

Related Publications (1)

  • Merchan-Galvis AM, Munoz-Garcia DA, Solano F, Velasquez JC, Sotelo NF, Molina DA, Caicedo JP, Concha JM, Calvache JA, Martinez-Zapata MJ. Delayed surgery and health related quality of life in patients with proximal femoral fracture. Sci Rep. 2023 Jul 10;13(1):11131. doi: 10.1038/s41598-023-33592-3.

    PMID: 37429947DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Fracture Fixation, InternalHemiarthroplastyArthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, OperativeArthroplasty, ReplacementArthroplastyPlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Angela M Merchán Galvis, MD, MSc

    Universidad del Cauca

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela M Merchán Galvis, MD, MSc

CONTACT

+573176545717angelamerchan@unicauca.edu.co

Julian C Velasquez, MD

CONTACT

+57 3137966201jcvp25@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 1, 2020

First Posted

January 3, 2020

Study Start

January 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

CO(1)