Contribution of Stereography (EOS Imaging System) in the... | NCT03251534

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

NCT03251534

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Sep 10, 2018Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Femoral Shaft Fracture

Interventions

Centromedullary nailing

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

Sep 2017Actual

Completion Date

Sep 2018Actual

First Submitted Date

Aug 11, 2017

First Submission Date that Met QC Criteria

Aug 11, 2017

First Posted Date

Aug 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2018

Last Update Posted Date

Sep 10, 2018Actual

Name	Class
Clinical Investigation Centre for Innovative Technology Network	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Name	Type	Description	Arm Group Labels	Other Names
Centromedullary nailing	Procedure

Outcomes Module

Primary Outcomes

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 Outcomes

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).

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with surgery of femoral shaft fracture treated by nails

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tonetti Jerôme, MD, PhD	Orthopedic and Trauma department, University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopedic and Trauma Department, University Hospital, Grenoble Alpes		Grenoble		38043	France

References Module

Citations

Not provided