Hip FracturesHIPCCONCT04217642
Hip Fracture in Cauca. Cohort Study
An observational study of Hip Fractures, run by Universidad del Cauca at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Osteosynthesis
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2019to 31 Dec 2021
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults (male or female) ≥ 18 years of age
- Diagnosis of femoral fracture
- Receiving surgical treatment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Hospital Universitario San José
Popayán, Cauca Department, 19001
Angela M Merchán Galvis, MD, MSc, +57 3176545717, angelamerchan@unicauca.edu.co
Julian C Velasquez, MD, +57 3137966204, jcvp25@hotmail.com
About this study
Official title: Hip Fracture Cohort in Cauca: Factors That Delay Surgery and Its Outcomes.
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.
Read the detailed description
Hip fracture is an important cause of disability, functional risk and death in the adult population, being more significant in the elderly, it also entails high costs for the health system. Although it is usually rare before the sixth decade of life and is very rare in young people, patients who present a hip fracture functional risk can be very important, reaching prostration in up to 8% of cases when Your surgical management is delayed. It is known that the time elapsed between diagnosis and treatment that affects the survival of patients, because every two days of surgical waiting doubles the probability of death due to secondary complications such as infections and cardiovascular complications, which impacts on flexibility and quality. of the patient's life. In addition, it should be borne in mind that in occasions it is necessary to stabilize chronic pathologies of the patient, preventing this sea intervened in a timely manner.
At present there is no consensus on the intervention time of these fractures; However, previous studies have found that better results are obtained when surgical treatment is performed within the first 24 hours. In Colombia there are few published studies describing epidemiological characteristics, estimated time from admission to the surgical procedure, and the factors that specific to such delay. Due to the above and considering that hip fracture is considered a public health problem, it is important to identify sociodemographic factors and medical conditions that may be related to the postoperative complications, morbidity and mortality of these patients to help with the taking of therapeutic and administrative decisions that lead to improving the care provided and final results in the patient.
The general objective of this study is to identify the main causes of delay in surgical intervention in patients with a diagnosis of hip fracture of the San José university hospital during 2019 and its relationship with morbidity and mortality.
The research team has also proposed the following specific objectives to carry out this study:
- Describe socio-demographically the patients with a diagnosis of hip fracture, underwent surgery at the San José University hospital since 2019.
- Identify the reason that delay in surgical intervention.
- Quantify the main outcomes in morbidity and mortality during the 6 months after surgery, associated with the delay in surgery in the study population.
- Assess the quality of post-surgical life in the patient operated on for hip fracture.
- Correlate the delay in surgical intervention with complications and mortality in patients operated for hip fracture since 2019.
It is estimated to include 80 patients during the first year of recruitment. For the collection of information there is a sociodemographic survey, the EQ5D5L quality of life survey and comorbidity is evaluated taking into account the Charlson index.
- Conditions
- Hip Fractures
- Being tested
- Osteosynthesis
- Keywords
- Hip fractures, Delay surgery, Quality of life, Outcomes
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteosynthesisProcedure or surgery
Also called Hemiarthroplasty, Total hip arthroplasty
The specific surgical technique -osteosynthesis, hemiarthroplasty, or total hip arthroplasty- will depend on the characteristics of the proximal femur fracture in each patient.
| Study group | Role | What they receive |
|---|---|---|
| Delay surgery | Patients who have passed more than 48 hours from admission to surgery Receives: Procedure: Osteosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay surgery
Time, in hours, from emergency room admission until surgery.
Measured: 1 month
Secondary outcomes (2)
QoL
Quality of life whit the 5-level EQ-5D version (EQ-5D-5L generic questionnaire by EuroQol) assessed preoperatively and postoperatively at days 5 and 30 and months 6 and 12.
The EQ-5D-5L measures 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) related to quality of life. Each dimension has 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and extreme problems) which are scored from 1 (no problems) to 5 (extreme problems) points, with the maximum score of 1 indicating a state of full health.
Measured: 12 months
Mortality
All causes mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Universidad del Cauca
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario San José
- Responsible party
- Principal investigator, Angela Maria Merchan, Universidad del Cauca
- Investigators
- Angela M Merchán Galvis, MD, MSc, Principal investigator, Universidad del Cauca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217642
- Sponsor's protocol ID
- 5231
- Acronym
- HIPCCO
- Status last verified
- Jan 2021
- First submitted
- 1 Jan 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37429947
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Fracture Cohort in Cauca: Factors That Delay Surgery and Its Outcomes.
- ClinicalTrials.gov ID
- NCT04217642
- Acronym / sponsor ID
- HIPCCO / 5231
- Conditions
- Hip Fractures
- Keywords
- Hip fractures, Delay surgery, Quality of life, Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidad del CaucaUniversity, hospital or other
- Collaborators
- Hospital Universitario San José
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hip fracture is an important cause of disability, functional risk and death in the adult population, being more significant in the elderly, it also entails high costs for the health system. Although it is usually rare before the sixth decade of life and is very rare in young people, patients who present a hip fracture functional risk can be very important, reaching prostration in up to 8% of cases when Your surgical management is delayed. It is known that the time elapsed between diagnosis and treatment that affects the survival of patients, because every two days of surgical waiting doubles the probability of death due to secondary complications such as infections and cardiovascular complications, which impacts on flexibility and quality. of the patient's life. In addition, it should be borne in mind that in occasions it is necessary to stabilize chronic pathologies of the patient, preventing this sea intervened in a timely manner.
At present there is no consensus on the intervention time of these fractures; However, previous studies have found that better results are obtained when surgical treatment is performed within the first 24 hours. In Colombia there are few published studies describing epidemiological characteristics, estimated time from admission to the surgical procedure, and the factors that specific to such delay. Due to the above and considering that hip fracture is considered a public health problem, it is important to identify sociodemographic factors and medical conditions that may be related to the postoperative complications, morbidity and mortality of these patients to help with the taking of therapeutic and administrative decisions that lead to improving the care provided and final results in the patient.
The general objective of this study is to identify the main causes of delay in surgical intervention in patients with a diagnosis of hip fracture of the San José university hospital during 2019 and its relationship with morbidity and mortality.
The research team has also proposed the following specific objectives to carry out this study:
- Describe socio-demographically the patients with a diagnosis of hip fracture, underwent surgery at the San José University hospital since 2019.
- Identify the reason that delay in surgical intervention.
- Quantify the main outcomes in morbidity and mortality during the 6 months after surgery, associated with the delay in surgery in the study population.
- Assess the quality of post-surgical life in the patient operated on for hip fracture.
- Correlate the delay in surgical intervention with complications and mortality in patients operated for hip fracture since 2019.
It is estimated to include 80 patients during the first year of recruitment. For the collection of information there is a sociodemographic survey, the EQ5D5L quality of life survey and comorbidity is evaluated taking into account the Charlson index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delay surgery | – | Procedure: OsteosynthesisPatients who have passed more than 48 hours from admission to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adults (male or female) ≥ 18 years of age
- Diagnosis of femoral fracture
- Receiving surgical treatment
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsteosynthesisAlso: Hemiarthroplasty, Total hip arthroplastyThe specific surgical technique -osteosynthesis, hemiarthroplasty, or total hip arthroplasty- will depend on the characteristics of the proximal femur fracture in each patient. | Procedure or surgery | Delay surgery |
Primary outcome
Delay surgery
Time frame: 1 month
Time, in hours, from emergency room admission until surgery.
2 secondary outcomes
QoL
Time frame: 12 months
Mortality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 37429947Merchan-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela M Merchán Galvis, MD, MSc principal investigator
Universidad del Cauca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by Universidad del Cauca at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela M Merchán Galvis, MD, MSc (+573176545717, angelamerchan@unicauca.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay surgery (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04217642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.