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

Completed

• Conditions: Femoral Shaft Fracture

• Registration Number: NCT03251534
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-11
• Study First Posted: 2017-08-16
• Primary Completion: 2017-09
• Status Verified: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 rotation disorder with the clinical condition of the patient.	24 months	Rotation disorder (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).
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 the flessum-recurvatum after femoral nailing of fhe femoral shaft fractures	24 months	Flessum-recurvatum (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 the varus-valgus with the clinical condition of the patient	24 months	Varus-valgus (angle in degree).
Correlation of the flessum-recurvatum with the clinical condition of the patient.	24 months	Flessum-recurvatum (angle in degree)
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.

Trial Locations

Locations (1)

Orthopedic and Trauma Department, University Hospital, Grenoble Alpes; 🇫🇷 Grenoble, France