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Effectiveness of Early Definitive Fracture Fixation (E-FRAX) trial: A multicenter prospective observational study

Effectiveness of Early Definitive Fracture Fixation (E-FRAX) trial: A multicenter prospective observational study - E-FRAX study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000055269
Enrollment
1027
Registered
2024-08-19
Start date
2024-08-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fracture

Interventions

None listed

Sponsors

Keio University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Trauma- and surgery-related complications over six months from inclusion.

Countries

Japan

Contacts

Public ContactYusho Nishida

Keio University School of Medicine Department of Emergency and Critical Care Medicine

yushonishida@keio.jp03-3225-1323

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026