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

NCT ID: NCT03251534

Last Updated: 2018-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Femoral Shaft Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Centromedullary nailing

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Investigation Centre for Innovative Technology Network

NETWORK

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tonetti Jerôme, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Orthopedic and Trauma department, University Hospital, Grenoble

Locations

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Orthopedic and Trauma Department, University Hospital, Grenoble Alpes

Grenoble, , France

Site Status

Countries

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France

Related Links

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http://www.cic-it.fr/cic-it-grenoble.php

Clinical Investigation Centre for Innovative Technology Network

Other Identifiers

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DCIC-1550

Identifier Type: -

Identifier Source: org_study_id

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