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

Femoral Shaft Fracture Clinical Trial

— FEOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251534
• Other study ID #: DCIC-1550
• Status: Completed
• Start date: September 2015
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2018
• Est. primary completion date: September 2017
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Femoral Shaft Fracture
• Fractures, Bone

Intervention

Procedure:
• Centromedullary nailing

Locations

Country	Name	City	State
France	Orthopedic and Trauma Department, University Hospital, Grenoble Alpes	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Clinical Investigation Centre for Innovative Technology Network

Country where clinical trial is conducted

France, 

Outcome

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

External Links

•   Clinical Investigation Centre for Innovative Technology Network