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

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

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.

Study Overview

• Status: Completed
• Conditions: Femoral Shaft Fracture
• Intervention / Treatment: Procedure: Centromedullary nailing

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Orthopedic and Trauma Department, University Hospital, Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with surgery of femoral shaft fracture treated by nails

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of the rotation disorder with the clinical condition of the patient.	Rotation disorder (angle in degree).	24 months
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
Correlation of shortening or limb lengthening with the clinical condition of the patient.	Shortening or lengthening of limb (measured in mm).	24 months
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
Correlation of the varus-valgus with the clinical condition of the patient	Varus-valgus (angle in degree).	24 months
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
Correlation of the flessum-recurvatum with the clinical condition of the patient.	Flessum-recurvatum (angle in degree)	24 months
Idendification of the main risk factors of post-nailing rotational disturbances of femoral shaft fractures	Rotational disturbance (angle in degree)	24 months
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Clinical Investigation Centre for Innovative Technology Network
• Investigators: Principal Investigator: Tonetti Jerôme, MD, PhD, Orthopedic and Trauma department, University Hospital, Grenoble

Publications and helpful links

Helpful Links

• Clinical Investigation Centre for Innovative Technology Network

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Eos imaging stereography; Centromedullary nailing; Quantification of malunions
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: DCIC-1550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No