FEMORAL FRACTURESNCT03800186
Influence of Age on Trauma Femoral Fractures
An observational study of FEMORAL FRACTURES, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aimed to determine the influence of ageing on the incidence and site of femoral fractures in trauma patients, by taking the sex, body weight, and trauma mechanisms into account. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- FEMORAL FRACTURES
- What is being tested?
- Proximal type A, Proximal type B and Proximal type C
- How many people
- 3,859 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2018to 30 Dec 2018
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, 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 required patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury. Patients with incomplete data were excluded.
Who may be able to join
- Patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury
Who cannot join
- Patients with incomplete data were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Ageing on the Incidence and Site of Trauma Femoral Fractures: a Cross-sectional Analysis
This study aimed to determine the influence of ageing on the incidence and site of femoral fractures in trauma patients, by taking the sex, body weight, and trauma mechanisms into account.
Read the detailed description
This retrospective study reviewed data from adult trauma patients aged ≥ 20 years who were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2016. According to the femoral fracture locations, 3859 adult patients with 4011 fracture sites were grouped into five subgroups: proximal type A (n = 1,359), proximal type B (n= 1,487), proximal type C (n = 59), femoral shaft (n = 640), and distal femur (n = 466) groups. A multivariate logistic regression analysis was applied to identify independent effects of the univariate predictive variables on the occurrence of fracture at a specific site. The propensity score accounts for the risk of a fracture at a specific femoral site was calculated and presented visually with age in a two-dimensional plot.
- Conditions
- FEMORAL FRACTURES
- Being tested
- Proximal type A, Proximal type B, Proximal type C, femoral shaft, distal femur
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal type AOther
Patients with fracture of proximal type A
Proximal type BOther
Patients with fracture of proximal type B
Proximal type COther
Patients with fracture of proximal type C
femoral shaftOther
Patients with fracture of femoral shaft
distal femurOther
Patients with fracture of distal femur
| Study group | Role | What they receive |
|---|---|---|
| Trauma femoral fracture | Patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury. Patients were grouping into five subgroups as patients with fracture of proximal type A, proximal type B, proximal type C, femoral shaft, and distal femur. Receives: Other: Proximal type A; Other: Proximal type B; Other: Proximal type C; Other: femoral shaft; Other: distal femur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locations of femoral fracture
To provide a summary of covariate information regarding the occurrence of femur Fractures at a specific site.
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 posted11 Jan 2019
- Study start1 Jun 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
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
- 3,859 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TSANG-TANG Hsieh, MD, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800186
- Sponsor's protocol ID
- CDRPG8H0011
- Status last verified
- Jan 2019
- First submitted
- 6 Jan 2019
- Last updated
- 11 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 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Ageing on the Incidence and Site of Trauma Femoral Fractures: a Cross-sectional Analysis
- ClinicalTrials.gov ID
- NCT03800186
- Acronym / sponsor ID
- CDRPG8H0011
- Conditions
- FEMORAL FRACTURES
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,859 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 11 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 determine the influence of ageing on the incidence and site of femoral fractures in trauma patients, by taking the sex, body weight, and trauma mechanisms into account.
Detailed description
This retrospective study reviewed data from adult trauma patients aged ≥ 20 years who were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2016. According to the femoral fracture locations, 3859 adult patients with 4011 fracture sites were grouped into five subgroups: proximal type A (n = 1,359), proximal type B (n= 1,487), proximal type C (n = 59), femoral shaft (n = 640), and distal femur (n = 466) groups. A multivariate logistic regression analysis was applied to identify independent effects of the univariate predictive variables on the occurrence of fracture at a specific site. The propensity score accounts for the risk of a fracture at a specific femoral site was calculated and presented visually with age in a two-dimensional plot.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma femoral fracture | – | Other: Proximal type A, Other: Proximal type B, Other: Proximal type C, Other: femoral shaft, Other: distal femurPatients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury. Patients were grouping into five subgroups as patients with fracture of proximal type A, proximal type B, proximal type C, femoral shaft, and distal femur. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, 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 required patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury. Patients with incomplete data were excluded.
Key inclusion criteria (1 listed)
- Patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury
Key exclusion criteria (1 listed)
- Patients with incomplete data were excluded
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 |
|---|---|---|
| Proximal type APatients with fracture of proximal type A | Other | Trauma femoral fracture |
| Proximal type BPatients with fracture of proximal type B | Other | Trauma femoral fracture |
| Proximal type CPatients with fracture of proximal type C | Other | Trauma femoral fracture |
| femoral shaftPatients with fracture of femoral shaft | Other | Trauma femoral fracture |
| distal femurPatients with fracture of distal femur | Other | Trauma femoral fracture |
Primary outcome
Locations of femoral fracture
Time frame: up tp 2 months
To provide a summary of covariate information regarding the occurrence of femur Fractures at a specific site.
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 11 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.
TSANG-TANG Hsieh, MD study chair
Chang Gung Memorial Hospital
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 1 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 11 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?
Locations of femoral fracture (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 11 Jan 2019.