Contribution of Stereography (EOS Imaging System) in the Quantification of Femoral Shaft Fractures.

Contribution of Stereography in the Quantification of Malunions Femoral Shaft Fractures Operated by Centromedullary Nailing. A Case Serie of 40 Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03251534

Acronym

FEOS

Enrollment

Registered

2017-08-16

Start date

2015-09-30

Completion date

2018-09-30

Last updated

2018-09-10

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

Conditions

Femoral Shaft Fracture

Keywords

Eos imaging stereography, Centromedullary nailing, Quantification of malunions

Brief summary

This observational study is a collection of clinical and imaging data of patients with a femoral shaft fracture treated by nails. The aim of this research is the contribution of the EOS imaging system in the quantification of malunions.

Detailed description

The study is based on the collection of clinical and imaging data (using EOS imaging system) necessary for the follow-up of patients who have benefited, most often in the emergency, of a centromedullary nailing of the femoral shaft. The study does not lead to any further examination for the patient since they are followed until the removal of the material, which usually takes place 24 months after the fracture episode. This observational and pilot study is monocentric, prospective on a continuous series of 40 patients.

Interventions

PROCEDURECentromedullary nailing

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Inclusion criteria

* Patients aged at least 16 years (parental agreement signed for minors) or adults at the time of data collection * Patients with a femoral shaft fractures since january 2014 * Patients with a post-nailing femoral shaft fracture * Patients with unilateral fracture * Patients with regional origin allowing a follow-up in Grenoble center

Exclusion criteria

* Patients who refuse to sign a non-objective form * Patients with femoral shaft fracture untreted with nails

Design outcomes

Primary

Measure	Time frame	Description
Quantitative evaluation of rotational disturbances	24 months	Rotation disorder (degree angle), measured in a standardized and comparative way compared to the healthy side, by the EOS © software.

Secondary

Measure	Time frame	Description
Correlation of the rotation disorder with the clinical condition of the patient.	24 months	Rotation disorder (angle in degree).
Quantitative evaluation of the shortening or the lengthening of the operated limb (cranio-caudal plane).	24 months	Shortening or lengthening of the entire operative limb and of the femur alone (measured in mm), recorded in a standardized and comparative way compared to the healthy side, by the EOS © software
Correlation of shortening or limb lengthening with the clinical condition of the patient.	24 months	Shortening or lengthening of limb (measured in mm).
Quantitative evaluation of the varus-valgus (lateral-medial plane).	24 months	Varus-valgus (angle in degree), taken standardized and comparative way compared to the healthy side, by the EOS © software.
Correlation of the varus-valgus with the clinical condition of the patient	24 months	Varus-valgus (angle in degree).
Identification of the main risk factors of the flessum-recurvatum after femoral nailing of fhe femoral shaft fractures	24 months	Flessum-recurvatum (angle in degree).
Correlation of the flessum-recurvatum with the clinical condition of the patient.	24 months	Flessum-recurvatum (angle in degree)
Idendification of the main risk factors of post-nailing rotational disturbances of femoral shaft fractures	24 months	Rotational disturbance (angle in degree)
Identification of the main risk factors of limb shortening or lengthening (cranio-caudal plane) after femoral nailing of femoral shaft fractures.	24 months	Shortening or limb lengthening (measured in mm).
Identification of the main risk factors for the varus-valgus (lateral-medial plane) after femoral nailing of fhe femoral shaft fractures	24 months	Varus-valgus (angle in degree).
Quantitative evaluation of the flessum-recurvatum	24 months	Flessum-recurvatum (angle in degree), measured in standardized and comparative way compared to the healthy side, by the EOS © software.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026