Dating of Child Fractures : Chronological Repers From the Radiological Evolution of a Series of Femur Fractures (DFE)

Although several studies have studied the predictive nature of non-accidental trauma of the different types of fractures and in particular on the femur, the physiological and radiological particularities of the child make it difficult to estimate the age of a fracture and require defining a chronology specific to the specificities of the pediatric population. Some authors have carried out work for the dating of fractures, however the number of cases or the average age of the subjects does not allow a precise estimation of the chronology of evolution of the fractures.

Study Overview

• Status: Completed
• Conditions: Fractures in Children

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Child aged 18, cared for in the pediatric orthopedic department of the Strasbourg University Hospitals between January 2007 and December 2020

Description

Inclusion criteria:

• Child aged 18, cared for in the pediatric orthopedic department of the Strasbourg University Hospitals between January 2007 and December 2020
• Fracture of the femur resulting from orthopedic treatment instituted during a period of hospitalization
• Holders of parental authority who have been informed of the use of their child's data for the purposes of this research and who have not expressed any opposition

Exclusion criteria:

• Patient or legal representative who expressed their opposition to participating in the study
• Fracture of the femur having benefited from a surgical intervention
• Weakening metabolic or bone pathology
• Fracture on pathological focal lesion
• Fractures of the epiphysis or affecting the growth cartilage
• Impossibility of giving informed information to the subject

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Define retrospectively the chronology of the appearance of periosteal callus, secondary callus and remodeling phenomena from the study of radiographs of the femur	Evaluation of the time to radiographic appearance of the following stages defined by the number of days elapsed between the date of diagnosis of the fracture and the first radiography taken during follow-up, making it possible to highlight one of these phenomena: The radiographic periosteal reaction (or periosteal callus) defined by an opacity at the periphery of the fracture, corresponding to the first objectifiable calcification of the fracture hematoma and under the periosteum.; The secondary bone callus (or osteochondral) defined by a well-defined bone apposition of density close to that of the bone with opacification of the fracture line and union of the fracture site; Established remodeling activity when phenomena of axis correction, resorption of initial callus hypertrophy or re-permeabilizatio of the diaphyseal shaft can be demonstrated	Files analysed retrospectively from January 01, 2007 to December 31, 2020 will be examined

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Femur Fracture; FRACTURES IN CHILDREN; Pediatric population; Bony Callus
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: 7955 (CTEP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No