Femoral FracturesNCT03822000
Risk Factors and Complications Contributing to Mortality in Elderly Patients With Fall-Induced Femoral Fracture
An observational study of Femoral Fractures, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aimed to identify the risk factors and complications associated with mortality in elderly patients with femoral fracture after a fall from the ground level. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- Survival and Death
- How many people
- 2,407 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jan 2019to 28 Jan 2019
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: This retrospective study reviewed data from 27,462 trauma patients registered between January 1, 2009 and December 31, 2016. The inclusion criteria were age ≥65 years and hospitalization for the treatment of femoral fracture following a fall from standing height level (<1 m). This study excluded those patients with a fall from ≥1 m as well as those for whom incomplete data were available.
Who may be able to join
- Patients with a fall from ≥1 m as well as those for whom incomplete data were available.
Who cannot join
- those patients with a fall from ≥1 m
- patients with incompleted data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors and Complications Contributing to Mortality in Elderly Patients With Fall-Induced Femoral Fracture: A Cross-sectional Analysis Based on Trauma Registered Data
This study aimed to identify the risk factors and complications associated with mortality in elderly patients with femoral fracture after a fall from the ground level.
Read the detailed description
This retrospective study reviewed data pertaining to elderly patients aged ≥ 65 years who were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2017. Multivariate logistic regression analysis was performed to identify independent effects of univariate predictive variables on the occurrence of mortality.
- Conditions
- Femoral Fractures
- Being tested
- Survival, Death
- Keywords
- femur fracture, trauma, fall, elderly, mortality, respiratory complication
- Medical subject headings
- Femoral Fractures, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurvivalOther
Elderly patients with fall-induced femoral fracture who were survived.
DeathOther
Elderly patients with fall-induced femoral fracture who were dead.
| Study group | Role | What they receive |
|---|---|---|
| Elderly Patients with Femoral Fracture | Elderly patients with fall-induced femoral fracture. Patients were categorized into two groups: death (n = 42) and survival (n = 2,365). Receives: Other: Survival; Other: Death |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality was used as the primary outcome.
Measured: up tp 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start11 Jan 2019
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FracturesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822000
- Sponsor's protocol ID
- CDRPG8H0011-2
- Status last verified
- Jan 2019
- First submitted
- 28 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Complications Contributing to Mortality in Elderly Patients With Fall-Induced Femoral Fracture: A Cross-sectional Analysis Based on Trauma Registered Data
- ClinicalTrials.gov ID
- NCT03822000
- Acronym / sponsor ID
- CDRPG8H0011-2
- Conditions
- Femoral Fractures
- Keywords
- femur fracture, trauma, fall, elderly, mortality, respiratory complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,407 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 30 Jan 2019 (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 study aimed to identify the risk factors and complications associated with mortality in elderly patients with femoral fracture after a fall from the ground level.
Detailed description
This retrospective study reviewed data pertaining to elderly patients aged ≥ 65 years who were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2017. Multivariate logistic regression analysis was performed to identify independent effects of univariate predictive variables on the occurrence of mortality.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly Patients with Femoral Fracture | – | Other: Survival, Other: DeathElderly patients with fall-induced femoral fracture. Patients were categorized into two groups: death (n = 42) and survival (n = 2,365). |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This retrospective study reviewed data from 27,462 trauma patients registered between January 1, 2009 and December 31, 2016. The inclusion criteria were age ≥65 years and hospitalization for the treatment of femoral fracture following a fall from standing height level (<1 m). This study excluded those patients with a fall from ≥1 m as well as those for whom incomplete data were available.
Key inclusion criteria (1 listed)
- Patients with a fall from ≥1 m as well as those for whom incomplete data were available.
Key exclusion criteria (2 listed)
- those patients with a fall from ≥1 m
- patients with incompleted data
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 |
|---|---|---|
| SurvivalElderly patients with fall-induced femoral fracture who were survived. | Other | Elderly Patients with Femoral Fracture |
| DeathElderly patients with fall-induced femoral fracture who were dead. | Other | Elderly Patients with Femoral Fracture |
Primary outcome
Mortality
Time frame: up tp 2 months
Mortality was used as the primary outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Femoral Fractures, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jan 2019. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: up tp 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2019.