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Clinical Trials/NCT03251534
NCT03251534
Completed
Not Applicable

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

University Hospital, Grenoble1 site in 1 country40 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Femoral Shaft Fracture
Sponsor
University Hospital, Grenoble
Enrollment
40
Locations
1
Primary Endpoint
Quantitative evaluation of rotational disturbances
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
September 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

  • 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 rotation disorder with the clinical condition of the patient.(24 months)
  • Identification of the main risk factors of limb shortening or lengthening (cranio-caudal plane) after femoral nailing of femoral shaft fractures.(24 months)
  • Idendification of the main risk factors of post-nailing rotational disturbances of femoral shaft fractures(24 months)
  • Identification of the main risk factors of the flessum-recurvatum after femoral nailing of fhe femoral shaft fractures(24 months)
  • Quantitative evaluation of the shortening or the lengthening of the operated limb (cranio-caudal plane).(24 months)
  • Correlation of the varus-valgus with the clinical condition of the patient(24 months)
  • Correlation of the flessum-recurvatum with the clinical condition of the patient.(24 months)
  • Identification of the main risk factors for the varus-valgus (lateral-medial plane) after femoral nailing of fhe femoral shaft fractures(24 months)
  • Quantitative evaluation of the flessum-recurvatum(24 months)

Study Sites (1)

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