Clinical trial NCT03251534: Contribution of Stereography (EOS Imaging System) in the Quantification of Femoral Shaft Fractures.
Official title: Contribution of Stereography in the Quantification of Malunions Femoral Shaft Fractures Operated by Centromedullary Nailing. A Case Serie of 40 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Shaft Fracture
Keywords: Eos imaging stereography
Centromedullary nailing
Quantification of malunions
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2017-08-16
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with surgery of femoral shaft fracture treated by nails

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantitative evaluation of rotational disturbances
timeFrame: 24 months
Secondary outcomes:
measure: Correlation of the rotation disorder with the clinical condition of the patient.
timeFrame: 24 months
measure: Quantitative evaluation of the shortening or the lengthening of the operated limb (cranio-caudal plane).
timeFrame: 24 months
measure: Correlation of shortening or limb lengthening with the clinical condition of the patient.
timeFrame: 24 months
measure: Quantitative evaluation of the varus-valgus (lateral-medial plane).
timeFrame: 24 months
measure: Correlation of the varus-valgus with the clinical condition of the patient
timeFrame: 24 months
measure: Quantitative evaluation of the flessum-recurvatum
timeFrame: 24 months
measure: Correlation of the flessum-recurvatum with the clinical condition of the patient.
timeFrame: 24 months
measure: Idendification of the main risk factors of post-nailing rotational disturbances of femoral shaft fractures
timeFrame: 24 months
measure: Identification of the main risk factors of limb shortening or lengthening (cranio-caudal plane) after femoral nailing of femoral shaft fractures.
timeFrame: 24 months
measure: Identification of the main risk factors for the varus-valgus (lateral-medial plane) after femoral nailing of fhe femoral shaft fractures
timeFrame: 24 months
measure: Identification of the main risk factors of the flessum-recurvatum after femoral nailing of fhe femoral shaft fractures
timeFrame: 24 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Orthopedic and Trauma Department, University Hospital, Grenoble Alpes
Study officials:
affiliation: Orthopedic and Trauma department, University Hospital, Grenoble
name: Tonetti Jerôme, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: