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NCT Number: NCT03251534

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

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.

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Key information

Conditions

Femoral Shaft Fracture

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopedic and Trauma Department, University Hospital, Grenoble Alpes

Grenoble, 38043, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Centromedullary nailing

Procedure

Primary outcomes

  1. Quantitative evaluation of rotational disturbances

    Time frame: 24 months

    Rotation disorder (degree angle), measured in a standardized and comparative way compared to the healthy side, by the EOS © software.

Secondary outcomes

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

    Time frame: 24 months

    Rotation disorder (angle in degree).

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

    Time frame: 24 months

    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

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

    Time frame: 24 months

    Shortening or lengthening of limb (measured in mm).

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

    Time frame: 24 months

    Varus-valgus (angle in degree), taken standardized and comparative way compared to the healthy side, by the EOS © software.

  5. Correlation of the varus-valgus with the clinical condition of the patient

    Time frame: 24 months

    Varus-valgus (angle in degree).

  6. Quantitative evaluation of the flessum-recurvatum

    Time frame: 24 months

    Flessum-recurvatum (angle in degree), measured in standardized and comparative way compared to the healthy side, by the EOS © software.

  7. Correlation of the flessum-recurvatum with the clinical condition of the patient.

    Time frame: 24 months

    Flessum-recurvatum (angle in degree)

  8. Idendification of the main risk factors of post-nailing rotational disturbances of femoral shaft fractures

    Time frame: 24 months

    Rotational disturbance (angle in degree)

  9. Identification of the main risk factors of limb shortening or lengthening (cranio-caudal plane) after femoral nailing of femoral shaft fractures.

    Time frame: 24 months

    Shortening or limb lengthening (measured in mm).

  10. Identification of the main risk factors for the varus-valgus (lateral-medial plane) after femoral nailing of fhe femoral shaft fractures

    Time frame: 24 months

    Varus-valgus (angle in degree).

  11. Identification of the main risk factors of the flessum-recurvatum after femoral nailing of fhe femoral shaft fractures

    Time frame: 24 months

    Flessum-recurvatum (angle in degree).

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Clinical Investigation Centre for Innovative Technology Network

Registry information

Official study title

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

Acronym: FEOS

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Aug 16, 2017
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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