NCT03251534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

August 11, 2017

Last Update Submit

September 7, 2018

Conditions

Femoral Shaft Fracture

Keywords

Eos imaging stereographyCentromedullary nailingQuantification of malunions

Outcome Measures

Primary Outcomes (1)

  • 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 (11)

  • Correlation of the rotation disorder with the clinical condition of the patient.

    24 months

  • Quantitative evaluation of the shortening or the lengthening of the operated limb (cranio-caudal plane).

    24 months

  • Correlation of shortening or limb lengthening with the clinical condition of the patient.

    24 months

  • Quantitative evaluation of the varus-valgus (lateral-medial plane).

    24 months

  • Correlation of the varus-valgus with the clinical condition of the patient

    24 months

  • +6 more secondary outcomes

Interventions

Centromedullary nailingPROCEDURE

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with surgery of femoral shaft fracture treated by nails

You may qualify if:

  • 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

You may not qualify if:

  • Patients who refuse to sign a non-objective form
  • Patients with femoral shaft fracture untreted with nails

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic and Trauma Department, University Hospital, Grenoble Alpes

Grenoble, 38043, France

Location

Related Links

Study Officials

  • Tonetti Jerôme, MD, PhD

    Orthopedic and Trauma department, University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 16, 2017

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2018

Last Updated

September 10, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)