UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055269 |
|---|---|
| Receipt number | R000063091 |
| Scientific Title | Effectiveness of Early Definitive Fracture Fixation (E-FRAX) trial: A multicenter prospective observational study |
| Date of disclosure of the study information | 2024/08/19 |
| Last modified on | 2024/08/17 16:03:02 |
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Basic information
Public title
Effectiveness of Early Definitive Fracture Fixation (E-FRAX) trial: A multicenter prospective observational study
Acronym
E-FRAX study
Scientific Title
Effectiveness of Early Definitive Fracture Fixation (E-FRAX) trial: A multicenter prospective observational study
Scientific Title:Acronym
E-FRAX study
Region
| Japan |
Condition
Condition
fracture
Classification by specialty
| Orthopedics | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Define early definitive fracture fixation (EDFF) as early surgical intervention for fractures of the extremities and pelvis resulting from blunt trauma, and investigate its impact on patient outcomes. Hypothesize that EDFF may reduce trauma- and surgery-related complications within six months of patient arrival, and validate this hypothesis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trauma- and surgery-related complications over six months from inclusion.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older with bone fractures resulting from blunt trauma, meeting one of the following criteria:
-Fractures of the extremities or pelvis with Abbreviated Injury Scale (AIS) scores ranging from 3 to 5.
-Fractures of the extremities or pelvis with AIS scores of 2 or higher, combined with other injuries at different body sites with AIS scores ranging from 2 to 5.
Key exclusion criteria
-Patients who present more than 24 hours after the injury.
-Patients with spinal cord injuries accompanied by paralysis.
-Cases of cardiac arrest before hospital arrival.
-Cases of cardiac arrest in the emergency department.
-Patients with proximal femur fractures (however, fractures accompanying the inclusion criteria are allowed).
-Patients who underwent abdominal, thoracic, or cranial surgery, or surgery for hemostasis including interventional radiology, prior to definitive fracture fixation.
-Patients who received external fixation before definitive fracture fixation (the external fixation does not need to be limited to the same site as the definitive fracture fixation).
-Patients who have expressed a refusal to participate in the study.
-Patients deemed unsuitable for participation by the clinical investigator.
Target sample size
1027
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | sasaki |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
1600016
Address
35 Shinanomachi Shinjuku Tokyo
TEL
03-3225-1323
sasaki.junichi@keio.jp
Public contact
Name of contact person
| 1st name | Yusho |
| Middle name | |
| Last name | Nishida |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
1600016
Address
35 Shinanomachi Shinjuku Tokyo
TEL
03-3225-1323
Homepage URL
yushonishida@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee of Ethics, Keio University School of Medicine
Address
35 Shinanomachi Shinjuku Tokyo
Tel
03-3353-1211
keio@esct.bvits.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical information will be collected at Day 0 (admission) and Day 1. Surgical-related information will also be collected. Data on survival, trauma- and surgery-related complications, and functional outcomes of the affected limb will be collected at 1 month and 6 months post-admission. Comparisons will be made between the EDFF group and the non-EDFF group for the above-mentioned items.
To adjust for observable confounders between the EDFF group and the control group and to accurately evaluate the time-varying treatment effect, we will perform inverse probability weighting (IPW) for time-varying treatment. The details are as follows:
Using the information collected at each time point from Day 0-1 as fixed-effect covariates and the facility as a random-effect covariate, we will apply a logistic regression mixed-effects model, using the administration of EDFF at each time point from Day 0-1 as the response variable. This will allow us to calculate the inverse probability weight (IPW) that accounts for the time-varying administration of EDFF, enabling the adjustment for background factors, including time-dependent covariates, between the two groups. Additionally, we will estimate the absolute difference in the primary outcome between the weighted EDFF and control groups by performing doubly-robust estimation, where the same covariates and primary outcome are regressed.
Considering that the observation period is six months long and that missing data on primary outcomes may lead to selection bias, multiple imputation will be used to complement the missing covariates and primary outcomes.
Management information
Registered date
| 2024 | Year | 08 | Month | 17 | Day |
Last modified on
| 2024 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063091
